Omicron Subvariant XBB.1.5 Accounts for 43% of US COVID Cases: CDC

January 16 2023

The fast-spreading Omicron subvariant XBB.1.5 is estimated to account for 43% of the COVID-19 cases in the United States for the week ended Jan. 14, data from the Centers for Disease Control and Prevention showed on Friday. The subvariant accounted for about 30% of cases in the first week of January, higher than the 27.6% the CDC estimated. XBB.1.5, which is related to Omicron, is currently the most transmissible variant. It is an offshoot of XBB, first detected in October, which is itself made from a combination of two other Omicron subvariants. The World Health Organization (WHO) said XBB.1.5 may spur more COVID-19 cases based on genetic characteristics and early growth rate estimates. While it is unclear if XBB.1.5 can cause its own wave of global infections, experts say the current booster shots continue to protect against severe symptoms, hospitalization and death. WHO Director General Tedros Adhanom Ghebreyesus tweeted the subvariant has been on the rise globally and has been identified in over 25 countries.

Paxlovid Has Been Free So Far. Next Year, More Will Pay

DECEMBER 15 2022

Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug — the uninsured and seniors — may have to pay the full price. And that means fewer people will get the potentially lifesaving treatments, experts said. In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes. But soon the Department of Health and Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.

Beyond Air Announces Positive Data for Inhaled Nitric Oxide (NO) to Treat COVID-19

NOVEMBER 16 2022

Beyond Air, Inc., a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced positive data from the LungFit PRO pilot study of high-concentration inhaled NO in Viral Community-Acquired Pneumonia (VCAP), including COVID-19. Incremental data from the completed pilot study was provided in a poster presentation at IDWeek 2022, held in Washington, DC. Initial topline data from the study were included in a presentation at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022) on April 25, 2022. “The analysis of the LungFit PRO study in VCAP patients further demonstrates improved efficacy on multiple parameters in the iNO treatment group compared to standard supportive treatment (SST). This is the fourth study in hospitalized subjects suffering from viral respiratory infections completed by Beyond Air with NO concentrations of 150 ppm or more with all studies having data showing a strong safety profile and statistically significant results on key endpoints. We believe high concentration NO delivery with the LungFit PRO generator and delivery system can be a powerful tool against any type of pneumonia, especially COVID-19, and our company is dedicated to bringing this important therapy to market as soon as possible,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. The multi-center, open-label, randomized clinical trial in Israel enrolled a total of 40 subjects hospitalized for VCAP (COVID-19, n=39; other viruses, n=1). Subjects were randomized in a 1:1 ratio to receive inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (NO + SST) or standard supportive treatment alone (SST, control group). Thirty-five subjects were included in the Intent To Treat (ITT) population, 16 in the inhaled NO + SST group and 19 in the control group. The primary COVID-19 treatments used during the study were Remdesivir (>30%) and Dexamethasone (>65%). Enrolled patients were followed for up to a 180-day period. The study endpoints include safety, and time on oxygen supplementation, among others. Safety data from the study show that inhaled NO treatment was well tolerated overall with no treatment related adverse events as assessed by the investigators. There were two SAEs reported in the group receiving inhaled NO along with SST, which were determined to be related to underlying conditions and unrelated to study device or NO. The efficacy results from the study are summarized below and show a trend of shortening LOS in favor of the inhaled NO treatment group. Also, duration of oxygen support, measured in-hospital and at home, was significantly shorter for inhaled NO treated subjects. Additionally, results from the study show a larger decline in c-reactive protein (CRP) from baseline for subjects treated with NO + SST compared to the control group.

Repeat COVID Infection Doubles the Risk of Death

NOVEMBER 15 2022

Getting COVID-19 a second time doubles a person's chance of dying and triples the likelihood of being hospitalized, a new study found. Vaccination and booster status did not improve survival or hospitalization rates among people who were infected more than once. "Reinfection with COVID-19 increases the risk of both acute outcomes and long COVID," study author Ziyad Al-Aly, MD, told Reuters. "This was evident in unvaccinated, vaccinated and boosted people." Researchers analyzed US Department of Veterans Affairs data:

  • 443,588 people with a first infection of SARS-CoV-2
  • 40,947 people who were infected two or more times
  • 5.3 million people who had not been infected with coronavirus, whose data served as the control group

"During the past few months, there's been an air of invincibility among people who have had COVID-19 or their vaccinations and boosters, and especially among people who have had an infection and also received vaccines; some people started to [refer] to these individuals as having a sort of superimmunity to the virus," Al-Aly said in a press release from the Washington University School of Medicine in St. Louis. "Without ambiguity, our research showed that getting an infection a second, third or fourth time contributes to additional health risks in the acute phase, meaning the first 30 days after infection, and in the months beyond, meaning the long COVID phase." Being infected with COVID-19 more than once also dramatically increased the risk of developing lung problems, heart conditions or brain conditions. The heightened risks persisted for six months.

Treatments Explored to Ease Post-Viral Symptoms of ME/CFS and Long COVID

AUGUST 15 2022

A variety of treatments, most already commercially available, are under investigation for treating the constellation of overlapping symptoms associated with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), “long COVID,” and dysautonomia. At the virtual annual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME), speakers presented data for a variety of approaches to ease symptoms common across post-viral conditions, such as extreme fatigue, post-exertional malaise ("crash"), cognitive dysfunction ("brain fog"), orthostatic intolerance including postural orthostatic tachycardia syndrome (POTS), and chronic pain. Most of the modalities are already commercially available for other indications, although some are costly and not covered by payers for these conditions. “Both post-acute COVID-19 syndrome and ME/CFS are forms of post-infectious viral syndromes and they have overlapping symptoms. … In the past, patients were told ‘you have chronic fatigue syndrome but there’s nothing we can do for it.’ That certainly is not the case. There aren’t cures, but there are many management techniques to improve symptoms,” Charles W. Lapp, MD, medical director of the Hunter-Hopkins Center, Charlotte, North Carolina, said. A current mainstay of treatment for ME/CFS — including that triggered by COVID-19 — is activity pacing, in which patients learn to stay within their “energy envelopes” in order to avoid post-exertional malaise, a worsening of all symptoms with exertion. The use of “graded exercise” is no longer recommended, per UK and US guidelines.

Pandemic Tied to Misdiagnosis of Rare Pneumonia

JULY 29 2022

Psittacosis, a rare disease, has been underdiagnosed or misdiagnosed during the COVID-19 pandemic, likely because the symptoms of the disease are similar to COVID-19 symptoms, researchers suggest on the basis of data from 32 individuals. Diagnosis of and screening for COVID-19 continues to increase; however, cases of atypical pneumonia caused by uncommon pathogens, which presents with similar symptoms, may be missed, wrote Qiaoqiao Yin, MS, of Zhejiang Provincial People's Hospital, China, and colleagues. "The clinical manifestations of human psittacosis can present as rapidly progressing severe pneumonia, acute respiratory distress syndrome, sepsis, and multiple organ failure," but human cases have not been well studied, they say.

In a study published in the International Journal of Infectious Diseases, the researchers reviewed data from 32 adults diagnosed with Chlamydia psittaci pneumonia during the COVID-19 pandemic between April 2020 and June 2021 in China. The median age of the patients was 63 years, 20 were men, and 20 had underlying diseases.

A total of 17 patients presented with fever, cough, and expectoration of yellow-white sputum. At the time of hospital admission, three patients had myalgia, two had headache, and two had hypertension. The patients were originally suspected of having COVID-19.

"All patients showed atypical pneumonia, including inflammatory infiltration, pleural effusion, multiple inflammatory exudative lesions with interstitial edema, lung abscesses and white lung," all of which could be observed in COVID-19 patients as well, the researchers write. RT-PCR and ELISA testing were used to rule out COVID-19. The researchers then used metagenomic next-generation sequencing (mNGS) to identify the disease-causing pathogens. They collected 18 bronchoalveolar lavage fluid (BALF) samples, nine peripheral blood samples, and five sputum samples. The mNGS identified C psittaci as the suspected pathogen within 48 hours. Suspected C psittaci infections were confirmed by endpoint PCR for the BALF and sputum samples and 6 of 9 blood samples, "indicating a lower sensitivity of PCR compared to mNGS for blood samples," the researchers say. No other potential pathogens were identified.

Psittacosis is common in birds but is rare in humans. C psittaci is responsible for 1% to 8% of cases involving community-acquired pneumonia in China, the researchers note. Although poultry is a source of infection, 25 of the patients in the study did not report a history of exposure to poultry or pigeons at the time of their initial hospital admission. Many patients may be unaware of exposures to poultry, which further complicates the C psittaci diagnosis, they note.

Millions of Siemens Healthineers Rapid COVID-19 Antigen Self-Tests Now Available in the US

FEB 2 2022

Siemens Healthineers announced the CLINITEST Rapid COVID-19 Antigen Self-Test is now available in the US to self-test for the SARS-CoV-2 virus. The CLINITEST Rapid COVID-19 Antigen Self-Test uses a simple nasal swab to provide accurate COVID-19 test results (including for both the Omicron and Delta variants) in 15 minutes and comes in a five-test-per-box configuration—convenient for families, group, and/or serial testing needs. The test is approved for unsupervised self-testing by individuals ages 14 and older, and adult-collected samples from individuals ages 2-13, with or without symptoms. "Siemens Healthineers is bringing millions of rapid COVID-19 antigen tests to the United States to make them available to the American people at a time when the tests are desperately needed," said Jennifer Zinn, Executive Vice President and Head of Diagnostics, North America, Siemens Healthineers. "Since receiving Emergency Use Authorization for the CLINITEST Rapid COVID-19 Antigen Self-Test in December, we’ve worked tirelessly to leverage every pathway to bring the tests to the public as quickly as possible. This is in addition to the tremendous efforts we've successfully undertaken to make these tests widely available in Europe." The company has been selected as a test supplier to support the US federal government’s efforts to ship tests directly to households. Siemens Healthineers committed to making tens of millions of tests available for the federal government over the next two months. Additionally, Siemens Healthineers is supplying millions more tests for state government programs and to nonprofit organizations. Siemens Healthineers also is supplying the antigen tests to healthcare institutions across the country to ensure front-line workers can continue to care for patients safely. "As Americans struggle to access COVID-19 tests amidst the latest surge, we were eager to step in to help workers and students be safe," said Randi Weingarten, President, American Federation of Teachers. “Working with Siemens Healthineers we are helping educators and school staff, as well as nurses and others we represent, get the supplies they need to keep themselves, their families, and their students safe. Rapid tests provide the peace of mind necessary for our nation's schools to remain safely in person—where students do best—without risking the spread of COVID. Pandemic safety remains a community-wide effort, and with this critical inventory and partnership from Siemens Healthineers, we can help get more tests into the hands of people who need them most."

Volunteers Needed to Catch COVID in the Name of Science

Jan 28 2022

The world's first medical trial authorised to deliberately expose participants to the coronavirus is seeking more volunteers as it steps up efforts to help develop better vaccines. The Oxford University trial was launched last April, three months after Britain became the first country to approve what are known as challenge trials for humans involving COVID-19. Its first phase, still ongoing, has focused on finding out how much of the virus is needed to trigger an infection while the second will aim to determine the immune response needed to ward one off, the university said in a statement. Researchers are close to establishing the weakest possible virus infection that assures about half of people exposed to it get asymptomatic or mild COVID-19. They then plan to expose volunteers - all previously naturally infected or vaccinated - to that dose of the virus's original variant to determine what levels of antibodies or immune T-cells are required to prevent an infection. "This is the immune response we then need to induce with a new vaccine," said Helen McShane, Oxford University Professor of Vaccinology and the study's chief investigator. The trial's findings will help make future vaccine development much quicker and more efficient, the statement said.

As Omicron Surges, Effort to Vaccinate Young Children Stalls

Jan 28 2022

Two months after Pfizer’s covid vaccine was authorized for children ages 5 to 11, just 27% have received at least one shot, according to data from the Centers for Disease Control and Prevention. Only 18%, or 5 million kids, have both doses. The national effort to vaccinate children has stalled even as the omicron variant upends schooling for millions of children and their families amid staffing shortages, shutdowns and heated battles over how to safely operate. Vaccination rates vary substantially across the country, a KHN analysis of the federal data shows. Nearly half of Vermont’s 5- to 11-year-olds are fully vaccinated, while fewer than 10% have gotten both shots in nine mostly Southern states. Pediatricians say the slow pace and geographic disparities are alarming, especially against the backdrop of record numbers of cases and pediatric hospitalizations. School-based vaccine mandates for students, which some pediatricians say are needed to boost rates substantially, remain virtually nonexistent. “You have these large swaths of vulnerable children who are going to school,” said Dr Samir Shah, a director at Cincinnati Children’s Hospital Medical Center. Compounding the problem is that states with low vaccination rates “are less likely to require masking or distancing or other nonpartisan public health precautions,” he said.

COVID-19 Antigen Tests May Be Less Sensitive to Omicron: FDA

DEC 30 2021

Rapid antigen tests for COVID-19 might be less effective at detecting the Omicron variant that is spreading rapidly across the United States, according to the US Food and Drug Administration (FDA). Early data suggest that COVID-19 antigen tests "do detect the omicron variant but may have reduced sensitivity," the FDA said in a statement posted December 28 on its website. The FDA is working with the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative to assess the performance of antigen tests with patient samples that have the Omicron variant. The potential for antigen tests to be less sensitive for the Omicron variant emerged in tests using patient samples containing live virus, "which represents the best way to evaluate true test performance in the short-term," the FDA said. Initial laboratory tests using heat-activated (killed) virus samples found that antigen tests were able to detect the Omicron variant. "It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus," the FDA said. The agency continues to recommend use of antigen tests as directed in the authorized labeling and in accordance with the instructions included with the tests. They note that antigen tests are generally less sensitive and less likely to pick up very early infections compared to molecular tests. The FDA continues to recommend that an individual with a negative antigen test who has symptoms or a high likelihood of infection due to exposure follow up with a molecular test to determine if they have COVID-19. An individual with a positive antigen test should self-isolate and seek follow-up care with a healthcare provider to determine the next steps. The FDA, with partners and test developers, are continuing to evaluate test sensitivity, as well as the best timing and frequency of antigen testing.

COVID Booster Protection May Wane in About 10 Weeks, New Data Show

DEC 30 2021

Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain. U.K. health officials shared the data just before Christmas and noted that there haven’t been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death. “It will be a few weeks before effectiveness against severe disease with Omicron can be estimated,” U.K. Health Security Agency officials wrote in the report. “However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease.” Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to The New York Times. The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant. Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks. The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the U.K. through Dec. 20.

COVID-19 Asymptomatic Infection Rate Remains High

DEC 15 2021

Based on data from a meta-analysis of 95 studies that included nearly 30,000,000 individuals, the pooled percentage of asymptomatic COVID-19 infections was 0.25% in the tested population and 40.5% among confirmed cases. Asymptomatic infections remain potential sources of transmission for COVID-19, especially as communities reopen and public life resumes, but the percentage of these infections among those tested and among those diagnosed with COVID-19 has not been examined, wrote Qiuyue Ma, PhD, and colleagues of Peking University, Beijing, China. In a study published in JAMA Network Open, the researchers identified 44 cross-sectional studies, 41 cohort studies, seven case series, and three case series on transmission studies. A total of 74 studies were conducted in developed countries, including those in Europe, North America, and Asia. Approximately one third (37) of the studies were conducted among healthcare workers or in-hospital patients, 17 among nursing home staff or residents, and 14 among community residents. In addition, 13 studies involved pregnant women, eight involved air or cruise ship travelers, and six involved close contacts of individuals with confirmed infections. The meta-analysis included 29,776,306 tested individuals; 11,516 of them had asymptomatic infections. Overall, the pooled percentage of asymptomatic infections among the tested population was 0.25%. In an analysis of different study populations, the percentage was higher in nursing home residents or staff (4.52%), air or cruise ship travelers (2.02%), and pregnant women (2.34%), compared against the pooled percentage. The pooled percentage of asymptomatic infections among the confirmed population was 40.50%, and this percentage was higher in pregnant women (54.11%), air or cruise ship travelers (52.91%), and nursing home residents or staff (47.53%). The pooled percentage in the tested population was higher than the overall percentage when the mean age of the study population was 60 years or older (3.69%). By contrast, in the confirmed population, the pooled percentage was higher than the overall percentage when the study population was younger than 20 years (60.2%) or aged 20 to 39 years (49.5%). The researchers noted in their discussion that the varying percentage of asymptomatic individuals according to community prevalence might impact the heterogeneity of the included studies. They also noted the high number of studies conducted in nursing home populations, groups in which asymptomatic individuals were more likely to be tested. The study findings were limited by several factors, including the potential for missed studies that were not published at the time of the meta-analysis, as well as the exclusion of studies written in Chinese, the researchers noted. Other limitations included lack of follow-up on presymptomatic and covert infections, and the focus on specific populations, factors that may limit the degree to which the results can be generalized.

Pfizer Says COVID-19 Pill Near 90% Effective in Final Analysis

DEC 15 2021

Pfizer Inc said its antiviral COVID-19 pill showed near 90% efficacy in preventing hospitalizations and deaths in high-risk patients, and recent lab data suggests the drug retains its effectiveness against the fast spreading Omicron variant of the coronavirus. The U.S. drugmaker last month said the oral medicine was around 89% effective in preventing hospitalizations or deaths when compared to placebo, based on interim results in around 1,200 people. Data from its final analysis of the trial includes an additional 1,000 people. Nobody in the trial who received the Pfizer treatment died, compared with 12 deaths among placebo recipients. The Pfizer pills are taken with the older antiviral ritonavir every 12 hours for five days beginning shortly after onset of symptoms. If authorized, the treatment will be sold as Paxlovid. "It's a stunning outcome," Pfizer Chief Scientific Officer Mikael Dolsten said in an interview. "We're talking about a staggering number of lives saved and hospitalizations prevented. And of course, if you deploy this quickly after infection, we are likely to reduce transmission dramatically," Dolsten said. Pfizer also released early data from a second study suggesting that the treatment reduced hospitalizations by around 70% in a smaller trial of standard-risk adults, including some higher-risk vaccinated people. Pfizer said those results showed a positive trend, but were not statistically significant. They are following the results and plan to release data from the final 20% of participants in the 1,100-patient trial. The trial did not show that the drug alleviated symptoms of COVID-19 in that population. Dolsten said he expects authorization for use in high-risk individuals from the US Food and Drug Administration and other regulatory agencies soon. He does not believe an FDA advisory panel meeting will be needed. "We're in very advanced regulatory dialogues with both Europe and the UK, and we have dialogues with most of the major regulatory agencies globally," Dolsten said.

SARS-CoV-2 Testing Portfolio Detects Omicron Variant

DEC 9 2021

Siemens Healthineers has announced that the company’s SARS-CoV-2 tests are well designed to detect the Omicron SARS-CoV-2 variant. The company recently evaluated the potential impact of the emergent variant on the CLINITEST Rapid COVID-19 Antigen Test, the FTD SARS-CoV-2 Assay, a PCR test, and the Atellica IM / ADVIA Centaur SARS-CoV-2 Antigen Assay (CoV2Ag). On November 26, 2021, both the WHO and ECDC designated the Omicron variant as a variant of concern. Mutations are normal, abundant, and expected, especially with an RNA virus, and the SARS-CoV-2 is no different. As countries struggle to combat emerging variants, fast and accurate testing is an important tool in containing spread. To assess the potential impact to the CLINITEST rapid test and the Atellica/ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) Assay, the Siemens Healthineers R&D team analyzed the sequence data of the Omicron variant nucleocapsid protein. This analysis demonstrated >98% sequence homology of the nucleocapsid protein to other SARS-CoV-2 variants. Meaning, it is unlikely that the Omicron variant would affect the results. The CLINITEST Rapid COVID-19 Antigen Self-Test has a sensitivity of 97.25 percent and a specificity of 100 percent (compared to a PCR, or nucleic acid-detection method) and provides results in 15 minutes. The simple process for collecting a nasal swab and obtaining a result are included in the Instructions for Use. A nasal swab is collected from both nostrils and then the swab is washed in a buffer to reveal a specific protein inside the SARS-CoV-2 virus. The sample is then dispensed onto the test cassette and after 15 minutes the result is visible. The position and number of lines clearly indicate whether the test is positive or negative. The Siemens Healthineers’ CoV2Ag test shows strong alignment compared with on the market available automated real-time (RT)-PCR testing with sensitivity exceeding 96% and specificity exceeding 99% for the Atellica CoV2Ag test. While molecular RT-PCR diagnostic testing is the gold standard in accuracy, it lacks the high throughput capability of a lab-based, automated antigen test. With availability of CoV2Ag on the Atellica IM Analyzer, laboratories can significantly increase the SARS-CoV-2 testing capacity with a platform that can run up to 440 tests per hour. Siemens Healthineers has also confirmed, based on in silico analysis, that the FTD SARS-CoV-2 Assay, a PCR-based test, detects the Omicron variant. Dual target design makes it possible to detect two different genomic regions of SARS-CoV-2. One benefit of this is a higher sensitivity because it is possible to detect two different genomic regions on the same detection channel, but most important right now, is that it helps to cope with mutations. Siemens Healthineers offers an evolving menu of single mutation PCR reflex tests that complement our FTD SARS-CoV-2 Assay to identify SARS-CoV-2 variants. Our relationship with A1 Life Sciences allows us to offer research use only tests (RUO). that enable laboratories to efficiently detect mutations to discriminate between circulating variants, including Omicron. “As a leader in laboratory diagnostics, Siemens Healthineers is committed to monitoring all current and emerging variants of concern to ensure the test results remain accurate and reliable,” said Deepak Nath, PhD, President Laboratory Diagnostics, Siemens Healthineers. “Accurate diagnostic tools are a critical factor in allowing public health authorities to combat the spread of virus and protect the health of their populations.”

What We Know, What We Don’t About the Omicron Variant

NOV 30 2021

A new COVID-19 variant known as Omicron has global health officials concerned as scientists race to discover how mutations will impact the transmission and severity of the virus. Here’s what we know. Omicron, officially known as B.1.1.529, was designated a variant of concern on November 26 by the World Health Organization (WHO). The designation was made based on evidence presented to the WHO's Technical Advisory Group on Virus Evolution that Omicron has several mutations that may affect how the variant behaves, ie, the severity of disease it causes, its degree of transmissibility, and the variant's immune escape potential — that is, whether it can bypass protection offered by current COVID-19 vaccines. Omicron was first identified in South Africa and reported to the WHO on November 24; it has now been detected in Australia, Belgium, Botswana, Britain, Denmark, Germany, Hong Kong, Israel, Italy, the Netherlands, France, Canada, and South Africa. At least 44 countries have imposed travel restrictions from several African countries, reports CNN. Japan and Israel have banned all foreign nationals from entering their countries. Health officials in Canada confirmed the country's first 2 cases in Ottawa, November 28. There have been 50 mutations identified in the B.1.1.529 lineage, the most concerning being more than 30 in the spike protein region, the area that facilitates a virus' entry into the host cell, enhancing its transmissibility as well as the potential for immunoescape. WHO notes, however, that it is not clear yet whether the variant is more transmissible compared to other recent variants, including Delta. While the number of persons testing positive for Omicron has increased in areas of South Africa where circulation has been identified, studies have been launched to understand if the variant is to blame or if other factors may be implicated. There are as yet no data to clarify whether Omicron causes more severe disease compared to other variants, and WHO again points to Delta as the primary comparator. “Preliminary data suggest that there are increasing rates of hospitalization in South Africa, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with Omicron,” states WHO. Nor is there any suggestion that symptoms associated with Omicron infection are different from those seen with currently circulating variants. According to a report from Reuters, a South African physician who was among the first clinicians to suspect a different strain of the coronavirus among patients he saw said that “the symptoms of the Omicron variant were so far mild and could be treated at home.” The chair of South African Medical Association, also speaking, said that no patients so far have reported loss of smell or taste and there has been no major drop in oxygen levels observed. According to WHO, initial reported infections were among university students who overall tend to have milder infection and symptoms. Better understanding of both infectivity and transmissibility of Omicron will likely take several weeks, the WHO stressed, as will accruing information on whether the variant can potentially render current vaccinations less effective. “Work is already under way to look at the immune escape potential of B.1.1.529 in the laboratory setting,” note scientists with South Africa’s National Institute for Communicable Diseases (NICD) in a statement. “Based on our understanding of the mutations in this lineage, partial immune escape is likely, but it is likely that vaccines will still offer high levels of protection against hospitalization and death.” Effectiveness of current tests is currently not in question, according to WHO, as the widely used PCR assays continue to detect infection, including with Omicron. Research is underway to assess any potential impact of the variant on other tests including rapid antigen detection tests. Treatments for COVID-19 also are being assessed for efficacy against Omicron infection but WHO stresses that both corticosteroids and IL-1 receptor antagonists will continue to be effective against severe COVID-19. In statements, leaders from both Pfizer-BioNTech and Moderna said virus mutations have been anticipated since the beginning and that the companies are working closely with authorities to process information as soon as it is available.

Merck's COVID-19 Pill May Be Less Effective Than First Hoped

NOV 30 2021

Merck’s antiviral pill for COVID-19, molnupiravir, appears to be far less effective than early results from the clinical trial first suggested. According to an analysis by scientists at the FDA, the experimental pill cut the risk of hospitalization or death from COVID-19 by about 30%, compared to a placebo, and the pill showed no benefit for people with antibodies against COVID-19 from prior infection. The updated analysis showed 48 hospitalizations or deaths among study participants who were randomly assigned to take the antiviral drug, compared to 68 among those who took a placebo. Those results come from the full set of 1,433 patients who were randomized in the clinical trial, which just became available last week. Initial results from the first 775 patients enrolled in the clinical trial, which were issued in a company news release in October, had said the drug cut the risk of hospitalization or death for patients at high risk of severe disease by about 50%. Merck has been producing millions of doses of molnupiravir, which is the first antiviral pill to treat COVID-19 infections. The United Kingdom’s drug regulator authorized use of the medication in early November. The company said it expected to distribute the medication globally by the end of 2021. Last month, two Indian drug companies halted late-stage clinical trials of a generic version of molnupiravir after the studies failed to find any benefit to patients with moderate COVID-19. Trials in patients with milder symptoms are still ongoing. TheNew England Journal of Medicine postponed its planned early release of the molnupiravir study results, citing “new information.” The medication is designed to be given as four pills taken every 12 hours for 5 days. It’s most effective when taken within the first few days of new symptoms, something that requires convenient and affordable testing. The new results seem to put molnupiravir far below the effectiveness of existing treatments.

COVID-19 Breath Test Being Developed

OCT 28 2021

Instead of an invasive nasal swab, researchers at The Ohio State University Wexner Medical Center are exploring the use of a unique breath test for the rapid screening of patients for COVID-19. Results from the initial study in patients, published today in the journal PLOS ONE, found the breath test is highly accurate in identifying COVID-19 infections in critically ill patients. "The gold standard for diagnosis of COVID-19 is a PCR test that requires an uncomfortable nasal swab and time in a lab to process the sample and obtain the results,” said Dr Matthew Exline, lead researcher, director of critical care at Ohio State Wexner Medical Center University Hospital and professor of internal medicine at The Ohio State University College of Medicine. “The breathalyzer test used in our study can detect COVID-19 within seconds.” COVID-19 infection produces a distinct breath print from the interaction of oxygen, nitric oxide and ammonia in the body. The breath detector device, developed by Pelagia-Irene Gouma, researcher and professor in the Department of Materials Science and Engineering and the Department of Mechanical and Aerospace Engineering at The Ohio State University and Milutin Stanaćević, associate professor in the Department of Electrical and Computer Engineering at Stony Brook University, can detect the breath print of COVID-19 in exhaled breath within 15 seconds. “This novel breathalyzer technology uses nanosensors to identify and measure specific biomarkers in the breath,” said Gouma. “This is the first study to demonstrate the use of a nanosensor breathalyzer system to detect a viral infection from exhaled breath prints.” The study followed 46 patients in the intensive care unit with acute respiratory failure that required mechanical ventilation. Half of the patients had an active COVID-19 infection and the remaining half didn’t have COVID-19. All patients had a PCR COVID-19 test when they were admitted to the unit. Researchers collected exhaled breath bags from the patients on day 1, 3, 7 and 10 of their inpatient stay. The breath bag samples were tested within 4 hours of sample collection in a lab. The breath print was identified in patients with COVID-19 pneumonia with 88% accuracy upon admission to the ICU. “PCR tests often miss early COVID-19 infections and results can be positive after the infection has resolved,” Exline said. “However, this noninvasive breath test technology can pick up early COVID-19 infection within 72 hours of the onset of respiratory failure, allowing us to rapidly screen patients in a single step and exclude those without COVID-19 on mechanical ventilation.” The use of breathalyzer technology to rapidly diagnose patients with respiratory infections has the potential to greatly improve the ability to rapidly screen both patients and asymptomatic people. Future studies will look at the use of this technology for less severe COVID-19 patients and will explore whether other diseases and infections could benefit from it. The research team has applied to the U.S. Food and Drug Administration for emergency use authorization of the breathalyzer technology.

Doctors Divided About Need for COVID-19 Boosters: Poll

Sep 15 2021

Current scientific evidence does not indicate that people who are not immunocompromised need booster shots of COVID-19 vaccines, a team of experts write in a viewpoint article in The Lancet. Research shows that the vaccines remain effective at preventing severe COVID-19, according to the group of experts. They include two high-level officials in the office of the US Food and Drug Administration that regulates vaccines who recently announced plans to leave the agency. Doctors and nurses in the United States are divided about the need for COVID-19 boosters and about how the United States should prioritize its supply of vaccines, according to a Medscape poll of more than 1700 clinicians that collected responses from August 25 to September 6. Overall, 71% of 575 US physicians who were polled said they thought the available evidence supports giving boosters to people who have already had two doses of the Moderna or Pfizer COVID-19 vaccines; 12% disagreed, and 17% said they were unsure. Of 1133 nurses surveyed, 66% said they thought evidence supports boosters, 15% disagreed, and 19% were unsure. More than three fourths of the 348 male physician respondents said they believed the evidence supports boosters; 64% of their female colleagues (208 were polled) shared this view. Responses varied by age: 74% of physicians and 70% of nurses aged 55 and older said they believed the evidence supports boosters. Fewer of their younger colleagues (61% of doctors and 56% of nurses) agreed. Doctors based outside the United States were significantly less likely than US doctors to say the evidence supports boosters. Only 42% of about 200 doctors based outside the United States thought boosters are needed; 32% said the evidence doesn't support boosters, and 27% said they were unsure.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV1) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute, in Stockholm, Sweden.

"We found no effect of COVID-19 on spirometric lung function in generally healthy adults," she said in oral abstract presented at the European Respiratory Society (ERS) 2021 International Congress, which was held online.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

"The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults," commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London, United Kingdom.

"We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function," she said. Simonds was not involved in either study.

COVID-19 Spares Lung Function in Young Adults

Sep 15 2021

Here's some encouraging news for once regarding SARS-CoV-2 infections: a study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma. Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV1) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute, in Stockholm, Sweden. "We found no effect of COVID-19 on spirometric lung function in generally healthy adults," she said in oral abstract presented at the European Respiratory Society (ERS) 2021 International Congress, which was held online. The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303). "The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults," commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London, United Kingdom. "We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function," she said. Simonds was not involved in either study.

FDA Authorizes Booster Shot for Immunocompromised Americans

Aug 13 2021

The US Food and Drug Administration has authorized a third dose of COVID-19 vaccines by Pfizer Inc (PFE.N)-BioNTech and Moderna Inc (MRNA.O) for people with compromised immune systems. The amended emergency use authorization paves the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose of the same shot they have initially received. Mixing of mRNA vaccines is permitted for the third shot if their original vaccine is not available. An advisory panel to the US Centers for Disease Control and Prevention (CDC) on Friday voted to recommend the additional doses, an important step before the policy is implemented. Patients will not need a prescription or the sign off of a health care provider in order to prove they are immunocompromised and receive the additional dose, according to CDC officials. “It will be a patient’s attestation, and there will be no requirement for proof or prescription or a recommendation from an individual’s health care provider,” CDC official Dr Amanda Cohn said, speaking before the Advisory Committee on Immunization Practice vote. The vulnerable group makes up less than 3% of U.S. adults, Rochelle Walensky, director of the CDC, had said before the authorization. “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines,” Janet Woodcock, U.S. FDA’s acting commissioner, said in a tweet. Woodcock said that others who are fully vaccinated do not need an additional vaccine dose right now.

Tachycardia Syndrome May Be a Distinct Marker for Long COVID

Aug 13 2021

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype. The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, Sweden, and colleagues was published online August 11 in The American Journal of Medicine. Ståhlberg said that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint. “We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said. Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report. “Systematic investigations suggest that 9% of Post-acute Covid-19 syndrome patients report palpitations at six months,” the authors write. The findings also shed light on potential tests and treatments, he said. “Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Ståhlberg said.

Highlighting the Effectiveness of the COVID-19 Vaccines Could Convert Doubters

JUL 13 2021

Informing people about how well the new COVID-19 vaccines work could boost uptake among doubters substantially, according to new research. The study, led by the University of Bristol and published in the British Journal of Health Psychology, shows the importance of raising awareness of vaccine efficacy, especially if it compares very favourably to another well-established vaccine. The research focused on adults who were unsure about being vaccinated against COVID-19. Those who were given information about the vaccine’s efficacy scored 20 per cent higher on a measure of willingness to be vaccinated, compared to those who received no information. This improved receptivity increased by as much as double among survey respondents who were also given information about how COVID-19 vaccines perform in comparison to the annual flu vaccine. Lead author Professor Colin Davis, Chair in Cognitive Psychology at the university’s School of Psychological Science, said: “The general positive effect of providing key information is not surprising, as we knew already that people’s perception of the effectiveness of a vaccine is an important factor in their vaccination intentions. But the extra benefit of providing comparative information is a novel finding which underscores the vital role of communication in improving vaccine uptake.” The findings come from two surveys of UK adults, aged between 18 and 85, last December. The first survey of 2,400 people revealed that 65 per cent agreed or strongly agreed they would have the COVID-19 vaccine, which at the time wasn’t widely available. A further 12 per cent were equally sure that they would not take the vaccine. However, in the middle range were around a quarter (23 per cent) of respondents who expressed reservations and uncertainty about whether they would be vaccinated. A second survey of 481 of those fence-sitters followed, which aimed to discover whether providing certain relevant information might nudge them to overcome their hesitancy and be more inclined to be vaccinated. When no information was given, the majority of the participants were unsure about having the vaccine. Confidence levels grew by some 20 per cent when they were told of the overwhelming efficacy of the Pfizer and Moderna vaccines, 95 per cent and 94 per cent respectively at the time. Their likelihood of being vaccinated grew by a similar margin again, when the information about the COVID-19 vaccine also stated the effectiveness of the flu vaccine over the past 15 years, according to the US Centers for Disease Control, which stands at some 40 per cent. “The findings show the positive potential of the contrast effect. Pointing out factual comparisons can be helpful when making a decision, particularly about something new. People value evidence-based information and this can provide affirmation and reassurance for cautious groups,” Professor Davis said. “It’s also important to note the information we provided about the lower effectiveness of the flu jab did not change people’s intention to have the flu vaccine. Perception of the flu vaccine benefits from its familiarity and an established sense of safety and efficacy. By positively associating the COVID-19 vaccine with the well-known flu jab, people are reminded that vaccines work and they are safe.” The latest figures show vaccine uptake is slowing. Over the last two months the average number of vaccine doses being administered daily has dropped from over half a million doses a day to just under a third of a million. This reflects a much lower rate of uptake among younger groups. In England while at least 95 per cent of 55 to 79-year-olds have had their first dose and at least 80 per cent of those aged 35 and above, the figure drops to some 76 per cent among 30 to 35-year-olds, 65 per cent for 25 to 29-year-olds, and just 57 per cent of 18 to 24-year-olds, according to latest NHS England data. Professor Davis said: “Younger people perhaps perceive themselves to be less vulnerable to COVID-19 virus. While mortality rates are fortunately much lower in this age group, exposure to the virus carries the danger of long-COVID in people of all ages. By getting vaccinated young people can protect themselves and also reduce transmission levels in the population as a whole. The vaccination campaign is by no means over and this study shows the importance of informed and targeted communication.”

Pfizer, Moderna Vaccine Protection May Last Months, or Longer

JUN 30 2021

Pfizer and Moderna's COVID-19 vaccines may provide protection against the virus for months — and much longer for those who had been infected and were later vaccinated, according to a new study. The study, published in the journal Nature, found either vaccine provided robust protection for at least 12 weeks following a second dose and could provide low-level protection for at least a year. Researchers say their study showed the vaccines provide "robust and prolonged" protection. The New York Times reported that researchers on this and other studies suggest COVID immunity might last for years, or even a lifetime, in people who had COVID, recovered, and were vaccinated. The researchers, led by Ali H. Ellebedy, PhD, of the Department of Pathology and Immunology at Washington University School of Medicine in St Louis, warn that variants of the virus that emerge in the future could change the effectiveness of the vaccines.

Respiratory Infection RSV Surges in South as Mask Use, Distancing Decline

JUN 30 2021

Doctors in Georgia and other Southern states have seen since April an unusual surge of a common respiratory virus that affects children and older adults. The spike in cases of respiratory syncytial virus (RSV) at this time of year is linked, at least in part, to children and others no longer widely wearing masks or social distancing to prevent COVID-19 infection, experts say. When masks began coming off, "we knew we'd see a really bad RSV season,'' said Dr Stephen Thacker, a pediatric infectious disease specialist in Savannah."Kids are getting infected at the same time.'' Thacker said the virus swept through his own household, starting with his youngest child. "I got it, too,'' he told GHN on Thursday. The CDC this month issued an advisory about the rise of RSV, which can lead to severe disease in young children and older adults. It's primarily spread via respiratory droplets when a person coughs or sneezes, and through direct contact with a contaminated surface. RSV is the most common cause of pneumonia and bronchiolitis (inflammation and congestion of the small airways in the lungs) in children under a year old in the United States. Each year in the US, the virus leads to an average of about 58,000 hospitalizations, with 100 to 500 deaths among children younger than 5 years old; and 177,000 hospitalizations with 14,000 deaths among adults aged 65 years or older. The virus is generally a leading cause of hospitalization for children in the nation. The risk is worse for children born prematurely and those with heart conditions or immune system problems, Thacker added. Fortunately, most people who get it, including infants, develop only mild symptoms like those of a common cold, such as congestion, runny nose, and coughing, the American Lung Association in Georgia said.

Almost All US COVID-19 Deaths Now in the Unvaccinated

JUN 30 2021

If you, a friend or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk for dying if you do become infected. That's the conclusion of a new report The Associated Press released looking at COVID-19 deaths during May 2021. Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That's less than 1%. "Recently I was working in the emergency room [and] I saw a 21-year-old African- American who came in with shortness of breath," says Vino K. Palli, MD, a doctor specializing in emergency medicine, internal medicine and urgent care. The patient deteriorated rapidly and required ventilation. She was transferred to a specialized hospital for in case she needed what’s known as ECMO treatment, where blood is pumped outside your body to remove carbon dioxide. "This patient was unvaccinated along with her entire family. This would have been easily preventable," says Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City. "Vaccine misinformation compounded with vaccine inertia and vaccine access has contributed to this," he says. “Even though we have a surplus amount of vaccines at this time we are only seeing 50 to 55% off completely vaccinated patients.” The AP report authors also acknowledge that some people who are fully vaccinated can get a “breakthrough infection” of COVID-19. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%. The AP came up with these numbers using CDC data. The CDC tracks the numbers of cases, hospitalizations and deaths, but does not break down rates by vaccination status. "The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination," says Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, NY. Stuart C. Ray, MD, professor of Medicine and Oncology in the Division of Infectious Diseases at Johns Hopkins University School of Medicine in Baltimore, says. "It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19, when they represent less than 50% of the adult population in the USA." The findings from the study could be more persuasive than previous arguments made in favor of immunization, Ray says. "These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss." Brian Labus, PhD, of the University of Nevada Las Vegas is less convinced. "While this might change some peoples' minds, it probably won't make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider."

Thrombosis With Thrombocytopenia After mRNA COVID-19 Vaccine

JUN 30 2021

What is believed to be the first case of thrombosis with thrombocytopenia after a messenger RNA COVID-19 vaccine has been reported. The case report is described in a letter to Annals of Internal Medicine published online today. A group led by Swathi Sangli, MBBS, Allegheny Health Network, Pittsburgh, Pennsylvania, describe what they say appears to be the development of vaccine-induced thrombosis with thrombocytopenia (VITT) or thrombocytopenia with thrombosis syndrome (TTS) in a 65-year-old man who had received a second dose of the Moderna mRNA-1273 vaccine 10 days before the onset of symptoms. The patient presented with 1 week of bilateral lower-extremity discomfort, intermittent headaches, and 2 days of dyspnea. He had no known prior heparin exposure. He was found to have large, bilateral, acute pulmonary emboli with right ventricular strain and acute deep venous thromboses in both lower extremities. The patient had severe thrombocytopenia, so it was decided not to give systemic anticoagulation and an inferior vena cava filter was placed. The patient received two doses of intravenous immunoglobulin followed by 40 mg of dexamethasone intravenously for 4 days for presumed immune-mediated thrombocytopenia. Unfractionated heparin therapy was initiated after platelet transfusions elevated his platelet count, but 3 days later, the patient developed an acute gluteal hematoma requiring withdrawal of heparin. The thrombocytopenia persisted, and on evaluation for heparin-induced thrombocytopenia (HIT), the anti-platelet factor 4/heparin IgG assay was strongly positive. Twelve hours later, he developed acute encephalopathy, and a CT scan showed cerebral venous sinus thrombosis. The lower-extremity deep venous thromboses progressed and a new upper-extremity deep venous thrombosis occurred. Blood cultures also showed methicillin-sensitive Staphylococcus aureus and antibiotics were given. Bivalirudin treatment and plasmapheresis was started but the patient continued to deteriorate and died. After his death, serum collected during admission (but before he received heparin) was strongly positive for anti-platelet factor 4/heparin IgG. The authors say that, in retrospect, this patient met the criteria for VITT, and the likelihood of this diagnosis is strengthened by the positive platelet factor 4 test of the blood drawn before heparin administration. "Although we believe the evidence supporting VITT in this case is robust, we cannot rule out atypical HIT or HIT with unrecorded heparin administration," they state. "Had we suspected VITT earlier, we would have treated the patient differently," they note, giving bivalirudin (or another recommended nonheparin anticoagulant) earlier, avoiding platelet transfusions, and conducting more extensive serologic testing of platelet-activating antibodies, as guidelines recommend. "In summary, we believe it is important to note that many millions of people have received COVID-19 vaccines that use mRNA technology. This is the only report to date of possible VITT or TTS in those recipients, and such a rare event, even if confirmed by additional reports, should not prevent persons from receiving the benefits of these vaccines," the authors write.

Getinge Gets FDA Clearance

JUN 24 2021

Getinge announces clearance from the US FDA of several new software options for the Servo-u and Servo-n ventilators. In addition to the latest software upgrades, Getinge also received clearance for the new Servo-u MR ventilator for the MRI room. “The COVID-19 pandemic and the heightened awareness of respiratory health has driven the need for personalized ventilation solutions for critically ill patients. Now more than ever, options for personalized lung protection and personalized weaning solutions are at the forefront of respiratory patient health. Getinge strives to support clinicians and patients by optimizing lung protection and delivering solutions for personalized ventilation,” said Eric Honroth, President, Getinge North America. With this software upgrade for the Servo-u and Servo-n combined, Getinge adds several new functionalities and options across all patient categories – adult, pediatric and neonatal. Getinge broadens its portfolio of lung-protective tools, including Automatic Stepwise Recruitment maneuver (Auto SRM), a standardized and automated workflow that guides lung recruitment and helps clinicians identify a personalized PEEP that provides the lowest driving pressure, which is a variable strongly associated with patient survival in ARDS1. Stress index and Transpulmonary pressure monitoring, including key parameters for assessment of lung stress during controlled and spontaneous ventilation, complements the lung protective toolkit, which was designed to optimally divide the cognitive workload between the clinician and the ventilator. Additionally, the clearance includes Heliox therapy. Heliox is a mixture of helium and oxygen that facilitates laminar flow and minimizes airway pressure due to its low density. This helps reduce the work of breathing (WoB) of patients suffering from obstructive lung diseases. Getinge also received clearance to introduce the Servo-u MR to the US market, a complement to the Servo Family, expanding Getinge’s platform of ventilators into the MRI room. Designed to guide the ventilator into a safe position, the Servo-u MR includes a magnetic field indicator with visual and audible alerts and an auto-lock handle that locks all four wheels as soon as the clinician releases the ventilator. “We are seeing a transformation in the way healthcare providers view respiratory health,” said Eric Honroth. “With this clearance, we are excited to be part of driving this transformation, working hand in hand with experts and clinicians.” Getinge remains committed to innovation in ventilation platforms. With its rich legacy of firsts, Getinge is proud to bring innovative products and solutions to clinicians through this most recent 510k clearance. The new options and the Servo-u MR ventilator are expected to be available in the US in July 2021.

EMA Launches Review of Clot Risk With AstraZeneca COVID Vaccine

MAR 15 2021

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is investigating cases of thromboembolic events related to AstraZeneca’s COVID-19 vaccine, but says the benefits currently still outweigh risks. As of March 10, 30 cases of thromboembolic events had been reported among nearly 5 million people vaccinated with the AstraZeneca vaccine in the European Economic Area, which includes European Union (EU) countries as well as Iceland, Liechtenstein, and Norway. The Danish Health Authority paused its vaccination campaign with the AstraZeneca vaccine last week as a precautionary measure while they investigate reports of blood clots in people who received the vaccine, including one individual who died, the EMA noted in a statement March 12. Now, several other European countries have temporarily stopped using the AstraZeneca vaccine based on similar reports, including Italy, Germany, France, the Netherlands and Ireland. The EMA issued an update today saying that suspending these vaccination campaigns are “a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who have received the vaccine.” Events involving blood clots, some with “unusual features” such as low numbers of platelets, have occurred in a “very small number” of people who received the vaccine, the new statement notes, and the number of events overall in vaccinated people “seems not to be higher than that seen in the general population.” The agency is working with AstraZeneca, experts in blood disorders, and other health authorities, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), where around 11 million doses have already been administered. “EMA’s investigation has been continuing over the weekend, and rigorous analysis of all the data related to thromboembolic events will be carried out in the coming days,” the agency notes. “Experts are looking in great detail at all the available data and clinical circumstances surrounding specific cases to determine whether the vaccine might have contributed or if the event is likely to have been due to other causes.”

At-Home COVID-19 Testing: Convenience, Cost, and Some Caveats

MAR 15 2021

At-home testing for COVID-19 features great convenience, but pathology experts caution that false positives, false negatives, out-of-pocket costs, and the potential for inadequate sampling from people swabbing their own noses or mouths could compromise results. Experts agree that COVID-19 testing has had its challenges and has evolved over the past year. “It’s a very, very significant day,” Kisha Mitchell Richards, MD, FCAP, director of pathology and laboratory at Greenwich Hospital, Greenwich, Connecticut, said at a March 11 webinar on COVID-19. The webinar was sponsored by the College of American Pathologists (CAP). “It’s one year ago today that the World Health Organization declared COVID-19 a pandemic and basically set in stone a year that was going to change our lives probably forever,” Richards said. During that time, “PCR testing” became more of a household term, community and preoperative testing changed and expanded, and more at-home tests gained emergency use authorization from the US Food and Drug Administration (FDA). Among them is the first molecular-based at-home test, which was approved earlier. However, the number and nuances of COVID-19 tests have left some people with questions. “People are still having difficulty understanding the tests. This may be due to the shift in focus to the vaccines and/or being overwhelmed and confused by the amount of information available,” said Patrick Godbey, MD, FCAP, president of CAP and laboratory director of Southeastern Pathology Associates and Southeast Georgia Health System, Brunswick, Georgia.

Vaccinators Put Squeeze on FDA to Relax Vaccine Handling Advice

MAR 15 2021

President Joe Biden has promised enough covid vaccine to immunize every willing adult by June 1. But the gap between supply and demand has been so dramatic that vaccinators discoveried ways to suck the final drops out of each vaccine vial — if federal regulators will let them. Pharmacists involved in the covid vaccination drive say it’s common to have half a dose left in a Pfizer vial after five or even six doses have been administered — and to have half a dose left after 10 doses have been drawn out of a Moderna vial. Combining two half-doses could increase vaccinations by thousands at a time when 2 million or so doses are being administered every day in the country. So, they want to use a single hypodermic needle to withdraw leftover vaccine from two vials from which all full doses already have been removed. The American Society of Health-System Pharmacists asked the Food and Drug Administration consider granting permission to do so in a recent letter. The governors of Colorado and Oregon also have sought permission to allow their pharmacists to pool covid vaccine vials. Federal health regulators, however, have long opposed the reuse of drug vials because of the risk of introducing a bacterial contaminant. From 1998 to 2014 more than 50 outbreaks of viral or bacterial disease were reported as a result of unsafe injection practices, including injecting multiple patients with a drug from the same vial. The FDA wouldn’t comment on the pharmacists’ letter but restated to KHN its current policy that “doses not be pooled from different vaccine vials, especially for coronavirus vaccines, which are not formulated with a preservative.” On its website, the Centers for Disease Control and Prevention explicitly tells vaccinators to discard vials “when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials to obtain a dose.” “It’s a recipe for disaster,” said Ann Marie Pettis, president of the Association for Professionals in Infection Control and Epidemiology. There is always a tiny chance that one of the two vials has previously been contaminated, which would contaminate a shot that combined their contents, she said. Spokespeople for both Moderna and Pfizer said excess portions of their vaccines must be discarded and never pooled. Johnson & Johnson had no comment on the issue.

Online COVID-19 Symptom Checkers May Not Catch Severe Illnesses

MAR 15 2021

Digital COVID-19 symptom checkers in the US and the UK may fail to identify severe COVID-19 and other serious illnesses such as bacterial pneumonia or sepsis, according to a group of public-health researchers. The online tools often advise patients to stay home and may prevent them from getting prompt treatment, the team writes in BMJ Health and Care Informatics. “As a frontline COVID doctor myself, I was concerned that the symptom checker was delaying the presentation of patients with severe COVID-19 to the hospital, and this was adding to the pressure on higher-dependency areas, such as” intensive-care units (ICUs), said senior author Dr Daniel Goyal of the Gibraltar Health Authority and Gibraltar’s COVID-19 Research Group. “The earlier we can identify pneumonia, the easier it is to facilitate recovery,” he told Reuters Health by email. “If patients present late, then they have higher mortality, higher rates of ICU admissions, longer admission, and they take much longer to recover, if they survive.” Dr Goyal and his colleagues ran a simulation study in April 2020 on nationwide symptom checkers in the U.S., UK, Japan and Singapore. They used 52 cases that represented typical COVID-19 presentations, including mild, moderate, severe and critical cases, as well as COVID-19 “mimickers” such as bacterial pneumonia and sepsis. The case scenarios included symptoms such as cough, fever and shortness of breath, along with underlying conditions, immunosuppression, age, symptom severity and symptom duration. They compared the recommendations, including whether patients were advised to seek medical care or stay at home. Overall, the research team found that the Japan and Singapore checkers were twice as likely to recommend medical care. About 88% of the Singapore cases were triaged onward, followed by 77% in Japan, 44% in the UK and 38% in the .S. Both the UK and US tools consistently failed to identify severe COVID-19, bacterial pneumonia and sepsis, often advising patients to stay at home and not seek care. The Singapore and Japan symptom checkers recommended clinical assessment after four days of symptoms, whereas the U.S. and the UK tools didn’t change based on the duration of symptoms. Age also didn’t appear to affect the recommendations in the U.S. or U.K., but all patients in Singapore over age 65 with viral symptoms and all “older adults” in Japan who had viral symptoms for more than two days were advised to seek medical care.

Fauci Worries About Possible Post-COVID ‘Mental Health Pandemic’

MAR 15 2021

Anthony Fauci, MD, says he’s concerned about how Americans will react once the coronavirus pandemic is brought under control, CBS News reports. Noting that an American Psychological Association survey showed people reporting high stress levels because of the pandemic, CBS’s Norah O’Donnell asked if Fauci was worried about a possible “mental health pandemic.” “Very much so,” Fauci, director of the National Institute of Allergy and Infectious Diseases and a top White House coronavirus advisor, replied. “That’s the reason why I want to get the virological aspect of this pandemic behind us as quickly as we possibly can because the long-term ravages of this are so multifaceted,” Fauci said. Some of the problems could include prolonged physical symptoms and the economic effects of the pandemic, he said. “And then the other things: Not only the mental health effects, but many people have put off routine types of medical examinations that they normally would have done,” Fauci said. “I hope we don’t see an increase in some preventable situations that would not have happened if people had the normal access to medical care, which clearly was interrupted by the shutdown associated with COVID-19.” The American Psychological Association released the survey results Thursday in what many people consider the 1-year anniversary of the start of the coronavirus pandemic. “The prolonged stress experienced by adults, especially the high levels of stress reported by Americans directly linked to the pandemic, is seriously affecting mental and physical health, including changes to weight, sleep and alcohol use,” the APA said in a news release.

First Pill for COVID-19 Could Be Ready by Year’s End

MAR 15 2021

New pills to treat patients with COVID-19 are currently in midstage clinical trials and, if successful, could be ready by the end of the year. Only one treatment — remdesivir (Veklury) — has been fully approved by the US Food and Drug Administration (FDA) for patients in the hospital and it must be administered intravenously. Hopes for a day when patients with COVID-19 can take a pill to rid their bodies of the virus got a boost over the weekend when early trial results were presented at a medical conference. Interim phase 2 results for the oral experimental COVID-19 drug molnupiravir, designed to do for patients with COVID-19 what oseltamivir (Tamiflu) can do for patients with the flu, were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2021 Annual Meeting. In the small study, the pill significantly reduced infectious virus in patients who were symptomatic and had tested positive for COVID-19 during the previous 4 days but were not hospitalized. After 5 days of treatment, no participants who received molnupiravir had detectable virus, whereas 24% who received placebo did. Two other oral agents are being developed by RedHill Biopharma: one for severe COVID-19 infection for hospitalized patients, and one for patients at home with mild infection. The first, opaganib (Yeliva), proceeded to a phase 2/3 global trial for hospitalized patients after the company announced topline safety and efficacy data in December. In phase 2, the drug was shown to be safe in patients requiring oxygen and effectively reduced the need for oxygen by the end of the treatment period.

California Leaders Look to Reopening, Push 1-Shot Vaccine

MAR 15 2021

California officials are contemplating what things will look like in the nation’s most populous state once millions of people are vaccinated and they move to phase out restrictions on gatherings and businesses that have altered life for a year. When officials last summer designed the four-tiered, yellow-to-purple system California now uses to decide whether people can dine indoors, go to the movies or gather with friends, they did not include a green tier — a recognition that a return to normalcy after the pandemic was far off. Now, Gov. Gavin Newsom’s administration is preparing to add one. “The likelihood of hitting that green tier is probably sooner than some of us thought when we were looking at the summer and fall,” Dr Mark Ghaly, California’s health secretary, said. State officials rely on a complicated formula, including virus spread, to determine which activities are restricted in each county. But a green designation won’t mean “go” for all things. Ghaly said such a label would still mean wearing masks and staying physically distant. He declined in an interview to offer more specifics on what restrictions would be maintained or to provide a threshold of vaccinations the state hopes to meet to allow such a go-ahead. State Public Health Director Dr Tomas Aragón forecast that California could achieve herd immunity when about 75% of the population has been vaccinated, though that could change as the virus mutates. That officials are optimistic enough to publicly discuss a green tier puts California in a dramatically different place than it was a few weeks ago during the state’s worst surge. Now case rates, hospitalizations and deaths are on the decline and vaccinations are on the rise.

CDC’s ‘Huge Mistake’

MAR 15 2021

Since the start of the pandemic, the most terrifying task in health care was thought to be when a doctor put a breathing tube down the trachea of a critically ill covid patient. Those performing such “aerosol-generating” procedures, often in an intensive care unit, got the best protective gear even if there wasn’t enough to go around, per Centers for Disease Control and Prevention guidelines. And for anyone else working with covid patients, until a month ago, a surgical mask was considered sufficient. A new wave of research now shows that several of those procedures were not the most hazardous. Recent studies have determined that a basic cough produces about 20 times more particles than intubation, a procedure one doctor likened to the risk of being next to a nuclear reactor. Other new studies show that patients with covid simply talking or breathing, even in a well-ventilated room, could make workers sick in the CDC-sanctioned surgical masks. The studies suggest that the highest overall risk of infection was among the front-line workers — many of them workers of color — who spent the most time with patients earlier in their illness and in sub-par protective gear, not those working in the covid ICU. “The whole thing is upside down the way it is currently framed,” said Dr Michael Klompas, a Harvard Medical School associate professor who called aerosol-generating procedures a “misnomer” in a recent paper in the Journal of the American Medical Association. “It’s a huge mistake,” he said. The growing body of studies showing aerosol spread of covid-19 during choir practice, on a bus, in a restaurant and at gyms have caught the eye of the public and led to widespread interest in better masks and ventilation. Yet the topic has been highly controversial within the health care industry. For over a year, international and US nurse union leaders have called for health workers caring for possible or confirmed covid patients to have the highest level of protection, including N95 masks. But a widespread group of experts have long insisted that N95s be reserved for those performing aerosol-generating procedures and that it’s safe for front-line workers to care for covid patients wearing less-protective surgical masks. Such skepticism about general aerosol exposure within the health care setting have driven CDC guidelines, supported by national and California hospital associations. The guidelines still say a worker would not be considered “exposed” to covid-19 after caring for a sick covid patient while wearing a surgical mask. Yet in recent months, Klompas and researchers in Israel have documented that workers using a surgical mask and face shield have caught covid during routine patient care.

COVID-19 Isolation and an Infant’s Immune System

MAR 15 2021

Queirra Fenderson, a first-time mom in Fort Washington, MD, gave birth to her daughter, Arya, at the end of December 2019. On the advice of their pediatrician, she and her husband spent the first month of their daughter’s life living in a “bubble” with only a few close family and friends seeing their baby to protect her from germs during cold and flu season. Right about the time the new parents were ready to start exposing Arya to more people and germs, the pandemic hit. So a year later, their 14-month-old still remains in that bubble. “There are still people to this day, some are my closest friends, who haven’t met her yet. It’s crazy,” Fenderson says. She says she and her husband have often wondered how this isolation is impacting their daughter’s developing immune system. They’ve even considered day care to boost her immunity, but balancing that against the risk of COVID-19 has led them to still keep her home. “Arya hasn’t been sick her whole entire life, and I want her to get more exposure to germs to boost her immunity. But in my gut, I’m afraid of the exposure to COVID, too,” Fenderson says. “Pandemic parenting is hard.” Simone Christensen of California agrees. She’s been very cautious with her 9-week-old daughter, Scout, who has seen only a few family members since she was born. Christensen has asthma, and their pediatrician has stressed the need to be cautious about COVID-19. But she and her husband also worry how isolation is impacting their daughter’s immune system. “Scout hasn’t really been exposed to much at this point, which seems crazy because I feel like at this age, I was probably sucking on a table at McDonald’s,” she says with a laugh. “Anytime you talk to someone who raised their child pre-pandemic, they always tell you how important it is to expose babies to germs so their immune system starts to build up, and I always thought I’d be the kind of mom who does that. But everything is different because of COVID. The risks are so much greater, and trying to figure out what’s best in a pandemic is scary and hard.” Leana Wen, MD, is an emergency room doctor and a public health expert. She’s also a mom whose second child — a 10-month-old girl — was born during the pandemic. She says there’s good reason to be cautious with babies and what you expose them to early in life. “Newborns are highly susceptible to illnesses,” she says. “They don’t have much of an immune system of their own, so even pre-pandemic, we advised people to be very careful to germ exposure with newborns, understanding that they develop more robust immune systems over time.” But many others, like B. Brett Finlay, PhD, a Canadian microbiologist and professor of microbiology at the University of British Columbia, also stress that early exposure to microbes has been shown to help a baby’s immune system develop well. “We’ve learned over the last decade or so that the normal development of the immune system absolutely requires the presence of normal microbes,” says Finlay, co-author of Let Them Eat Dirt: Saving Your Child from an Oversanitized World. “It makes a difference in childhood development, and lack of exposure to these good microbes affects allergies, asthma, eczema, obesity, and more,” We don’t know everything about how the immune system is built, “but we do know the end result is you need these early life microbes to get normal immune system development.” This question, often referred to as the hygiene hypothesis, was first raised in 1989, and it has long caused controversy and debate. It argues that the developed world’s focus on clean environments through the use of disinfectants, sanitizers, and bleach has a negative impact on the immune system. The FDA points out it is one of many explanations for “for asthma being the most common chronic disease in the developed world.” But plenty of others aren’t so sure. Researchers who published a study in 2016 found “no good evidence that hygiene, as the public understands, is responsible for the clinically relevant changes to microbial exposures.” The study, published in Perspectives in Public Health, says a combination of things, including “natural childbirth, breast feeding, increased social exposure through sport, other outdoor activities, less time spent indoors, diet and appropriate antibiotic use, may help restore the microbiome and perhaps reduce risks of allergic disease.” The hygiene hypothesis theorizes that cleanliness and lack of exposure to microbes have led to increased allergies, asthma, and other conditions.

New Device Delivers Warmed Respiratory Gases to Spontaneously Breathing Patients

MAR 4 2021

Masimo announced the US introduction of softFlow, innovative pulmonary care therapy which provides nasal high-flow warmed and humidified respiratory gases to spontaneously breathing patients. The technology, available on the softFlow 50, offers adult patients high-flow respiratory support through a soft nasal cannula by generating a consistent high flow of warm, humidified air or air/oxygen mixture. As the COVID-19 pandemic continues, increasing the number of patients suffering from respiratory conditions and requiring respiratory support, softFlow offers clinicians across the continuum of care an important tool to help in the treatment of spontaneously breathing patients. Capable of operating without an external compressed air supply, softFlow is designed for maximum versatility, with utility in settings throughout the hospital, long term-care facilities, and use at home. To reduce the risk of cross-contamination, softFlow uses a single-patient-use flow path from the internal mixing chamber to the patient and a bacterial/viral filter designed to filter contaminants from the air delivered to the patient. The US National Institutes of Health (NIH) and World Health Organization (WHO) have both suggested that the use of High-Flow Nasal Cannula (HFNC) therapy, like softFlow, is a viable option for providing respiratory support for select COVID-19 patients for whom conventional oxygen therapy may be insufficient. softFlow can provide patients suffering from COVID-19 or other respiratory conditions with higher flow rates of oxygen than conventional oxygen therapies. As a therapy, NIH concluded, “HFNC is preferred over Noninvasive Positive Pressure Ventilation (NIPPV) in patients with acute hypoxemic respiratory failure based on data from an unblinded clinical trial in patients without COVID-19 who had acute hypoxemic respiratory failure.” The referenced study found a higher number of ventilator-free days (24 days) with HFNC than with conventional oxygen therapy (22 days) or NIPPV (19 days) (p=0.02). The researchers also found a lower 90-day mortality rate compared to conventional oxygen therapy or NIPPV. With softFlow, the airflow is consistently delivered through the nose, allowing patients to continue to eat, drink, and speak, which is difficult with mask-based forms of respiratory support. In addition, the softFlow 50 system provides warm, humidified gas into the patient’s nose, to enhance comfort and aid in mucous clearance. With its ability to precisely deliver high respiratory gas flow rates well above those required for typical respiratory demand, clinicians can also take advantage of the high-flow rate to help limit the entrainment of room air (which can reduce the quantity of delivered inhaled oxygen). The innovative integrated airflow generator of the softFlow technology and water reservoir attachment allow for continued HFNC treatment of recovering COVID-19 patients in the home and other care settings, without the need for a separate source for high-flow air like other devices. The device’s simple, intuitive interface allows patients or their caregivers (who can lock settings) to easily customize the flow rate and humidification level. First available in 2016, softFlow is now in use in numerous countries in Africa, Asia, and Europe. Beijing Aerospace Changfeng Co., LTD, of China, noted, “We are very satisfied with the therapy successes we achieve with this device. We would like to emphasize the stable flow during inhalation and exhalation, which is generated by the powerful motor, which doesn’t need an external air source, as well as the resulting CO2 washing out. This fact opens up possibilities for [use as] a therapy for hypercapnic patients. Another very positive aspect of the device is the way it prevents condensation in the applicator by warming the entire tube system up to the nasal cannula. … All in all we are very satisfied with the handling of the device and the medical results.” Miguel Marina Barrio, Product Manager, Intensive Care Division, Hospital Hispania, Spain, added, “We already ordered 50 devices and we are very satisfied with the way softFlow performed. … In our opinion, the following points are very good: menu structure, product features, design, usability, manuals, delivery times. … The product quality, customer service, and type of packaging are particularly excellent.” Dr Dalal Al Matrouk, Head of Anesthesia and ICU at Farwaniya Hospital, Ministry of Health, Kuwait, said, “We have deployed 10 units of Masimo softFlow to help our clinicians manage patients with COVID-19-induced respiratory problems. We realize that high-flow nasal therapy could potentially help avoid invasive mechanical ventilation and its associated risks of ventilator-induced lung injury and hospital-acquired pneumonia.” Joe Kiani, Founder and CEO of Masimo, said, “We believe softFlow provides clinicians with an important tool to help address the growing number of people with compromised respiratory function, whether in high-acuity or low-acuity settings, including at home. We’re happy to now be able to offer this technology in the United States.”

Lab-based antigen test available on high-throughput analyzers

FEB 23 2021

Siemens Healthineers announced the company's laboratory-based SARS-CoV-2 Antigen Assay (CoV2Ag) obtained CE Mark and is now offered for the Atellica Solution and ADVIA Centaur analyzers, widely available in laboratories worldwide. The test has been submitted to the FDA for Emergency Use Authorization. The antigen test detects the nucleocapsid antigen and has been designed with five monoclonal antibodies with the objective to maximize its sensitivity to both current and future SARS-CoV-2 variants. It also offers a leading time-to-result for lab-based antigen tests, making it an ideal tool to test large quantities of patient samples quickly. Additionally, the test helps protect laboratory staff from the virus with a pretreatment process, which inactivates the virus without compromising the quality or validity of patient test results. The Siemens Healthineers' CoV2Ag test shows strong alignment to molecular RT-PCR methods with sensitivity exceeding 94% and specificity at 100% for the Atellica COVAg test. While molecular RT-PCR diagnostic testing is the gold standard in accuracy, it lacks the high throughput capability of a lab-based, automated antigen test. With availability of CoV2Ag on the Atellica IM Analyzer, laboratories can significantly increase the SARS-CoV-2 testing capacity with a platform that can run up to 440 tests per hour. Other benefits of lab-based, automated antigen testing include simplified pre-analytics and a more economical cost per test compared with RT-PCR testing, making this a cost effective solution to detect infection when high throughput is critical. Such testing could be deployed at on-site collection centers for hospital staff, patients and visitors, remote collection facilities for large scale testing of local populations or in dedicated, pop-up labs at airports or large universities. "SARS-CoV-2 antigen testing is a critical tool to help support the fight against COVID-19 and identify infected individuals, including those who are asymptomatic," said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. "High-throughput SARS-CoV-2 antigen testing can help laboratories rapidly scale their SARS-CoV-2 diagnostic testing capacity. The Siemens Healthineers' antigen test offers fast pretreatment time and time to results." The CoV2Ag assay is for in vitro diagnostic use in the qualitative detection of SARS-CoV-2 in nasopharyngeal swab and nasal swab specimens within the first seven days of symptom onset, or from asymptomatic individuals, using the Atellica IM Analyzer or ADVIA Centaur XP and ADVIA Centaur XPT immunoassay Systems. Siemens Healthineers has distinguished itself as a provider of quality assays to aid the COVID-19 pandemic. In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow-up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50121P00005.

Device Helps Make VAP Preventable

JAN 16 2021

The issue of secondary bacterial infection during a pandemic is nothing new. Per Dr. Fauci, “The majority of deaths in the 1918-1919 influenza (Spanish Flu) pandemic resulted directly from secondary bacterial pneumonia caused by common upper-respiratory-tract bacteria.” Today, half of the COVID problem is actually COVID. The other half is pneumonia or secondary bacterial infections which is preventable if hospitals use proper secretion management equipment. An estimated 150k+ COVID deaths involve VAP. VAP is preventable. The SIMEX device reduces VAP risk.
“Sadly, this is a very serious problem that is not going away and is getting worst and worst by the minute especially in California where the percentage of COVID ventilated patients dying due to VAP pneumonia is at 56% (10% higher than the national average),” said Hamid Khosrowshahi, President, FloSure Technologies’ LLC

Long-COVID Cases Rise as Stigma of Chronic Fatigue Taunts

JAN 16 2021

When Margot Gage-Witvliet began feeling run down after her family returned from a trip to the Netherlands in late February, she initially chalked up her symptoms to jet lag. Three days later, however, her situation went from concerning to alarming as she struggled to breathe. "It felt like there was an elephant sitting on my chest," she said. Her husband and daughters also became ill with COVID-19, but Gage-Witvliet was the only one in her family who didn't get better. After an early improvement, a rare coronavirus-induced tonic-clonic seizure in early April sent her spiraling back down. Gage-Witvliet spent the next several weeks in bed with the curtains drawn, unable to tolerate light or sound. Today, Gage-Witvliet's life looks nothing like it did 6 months ago when she first got sick. As one of COVID-19's so called long haulers, she continues to struggle with crushing fatigue, brain fog, and headaches — symptoms that worsen when she pushes herself to do more. Across the country, as many as one in 10 COVID-19 patients are reporting illnesses that continue for weeks and months after their initial diagnosis. Nearly all report neurologic issues like Gage-Witvliet, as well as shortness of breath and psychiatric concerns. For Avindra Nath, MD, a neurologist at the National Institutes of Health, the experience of these long-haul COVID-19 patients feels familiar and reminds him of myalgic encephalomyelitis, also known as chronic fatigue syndrome. Nath has long been interested in the lingering neurologic issues connected to chronic fatigue. An estimated three-quarters of all patients with chronic fatigue syndrome report that their symptoms started after a viral infection, and they suffer unrelenting exhaustion, difficulties regulating pulse and blood pressure, aches and pains, and brain fog. When Nath first read about the novel coronavirus, he began to worry that the virus would trigger symptoms in a subset of those infected. Hearing about the experiences of long-haulers like Gage-Witvliet raised his suspicions even more. Unlike COVID-19 long haulers, however, many patients with chronic fatigue syndrome go at least a year with these symptoms before receiving a diagnosis, according to a British survey. That means researchers have had few opportunities to study the early stages of the syndrome. "When we see patients with myalgic encephalomyelitis, whatever infection they might have had occurred in the remote past, so there's no way for us to know how they got infected with it, what the infection was, or what the effects of it were in that early phase. We're seeing them 2 years afterward," Nath said. Nath quickly realized that studying patients like Gage-Witvliet would give physicians and scientists a unique opportunity to understand not only long-term outcomes of COVID-19 infections, but also other postviral syndromes, including chronic fatigue syndrome at their earliest stages. It's why Nath has spent the past several months scrambling to launch two National Institutes of Health (NIH) studies to examine the phenomenon. Although Nath said that the parallels between COVID-19 long haulers and those with chronic fatigue syndrome are obvious, he cautions against assuming that they are the same phenomenon. Some long haulers might simply be taking a much slower path to recovery, or they might have a condition that looks similar on the surface but differs from chronic fatigue syndrome on a molecular level. But even if Nath fails to see links to chronic fatigue syndrome, with more than 92.5 million documented cases of COVID-19 around the world, the work will be relevant to the substantial number of infected individuals who don't recover quickly.

Microsoft, Cigna Form Coalition for Digital Records of COVID-19 Vaccination

JAN 16 2021

Tech giants including Microsoft Corp, Oracle Corp and healthcare companies Cigna Corp and Mayo Clinic are part of a coalition pushing for digital records of people who get vaccinated against COVID-19. The project, called Vaccination Credential Initiative, aims to help people get encrypted digital copies of their immunization records stored in a digital wallet of their choice, the companies said in a statement. Individuals without smartphones would receive paper printed with QR codes containing the credentials, they said. In the United States, where vaccines from Pfizer Inc and Moderna Inc have been authorized for emergency use, vaccinated individuals receive a vaccination card or printout. The current system does not readily support convenient access, control and sharing of verifiable vaccination records, the companies said.

Disinfecting During Pandemic Puts Asthmatics at Risk

JAN 16 2021

Increased cleaning by people with asthma during the pandemic may be triggering flares of their disease, a new report suggests. Researchers who surveyed 795 US adults with asthma between May and September found the proportion who disinfected surfaces with bleach at least five times a week rose by 155 percent after the pandemic started. Use of disinfectant wipes, sprays and other liquids also increased, the researchers reported in the Journal of Allergy & Clinical Immunology: In Practice. After accounting for other behaviors and risk factors, higher odds of having uncontrolled asthma were linked with greater household use of disinfectant wipes, disinfectant sprays, bleach and water solutions, and other disinfecting liquids. The study does not prove that increased frequency of disinfecting caused uncontrolled asthma. Still, the authors say, people with asthma need safer cleaning options. The Centers for Disease Control and Prevention advises asthmatics to ask someone else to clean and disinfect surfaces and to stay in another room when cleaners or disinfectants are used and right afterward. It also said soap and water may be sufficient for surfaces and objects that are seldom touched.




AI Platform Highlights Conference

MAY 29 2023

Optellum, a medtech company that provides a ground-breaking AI platform to diagnose and treat early-stage lung cancer, attended this year’s American Thoracic Society International Conference in conjunction with three prominent American healthcare institutions. Physicians from each of these institutions demonstrated how integrating Optellum Virtual Nodule Clinic into their clinical workflows offers benefits for both patients and providers. Dr Roger Kim and Dr Anil Vachani of Penn Medicine led a discussion called “Theoretical Net Benefit of a Radiomics-Based Computer-Aided Diagnosis Tool for Risk Stratification of Pulmonary Nodules.” The work at Vanderbilt Health demonstrates the cost-effectiveness of the AI platform, which was assigned CPT code 0721T in 2022 to facilitate health insurance claims for patients. Dr Vachani was the lead investigator for Optellum’s FDA clearance, the first of its kind achieved in 2021, and his work with Dr Kim showing that clinical decision making is better if the AI tool is incorporated into radiology or pulmonology practice was published in Radiology in 2022. Optellum Virtual Nodule Clinic is in use at other leading hospitals in the US and being rolled-out in a government-funded widespread screening trial in the UK’s National Health System (NHS). The company was named as one of the 150 most promising digital health companies of 2022 by CB Insights.

Sanofi: Smoker's Lung Drug Benefit Was Swift and Sustained in Trial

MAY 29 2023

The benefits of Sanofi and Regeneron's anti-inflammatory drug Dupixent set in quickly during a trial to treat "smoker's lung" and lasted for the duration of the 1-year study, French drugmaker Sanofi said. The company said it was discussing with major watchdogs across the world whether the trial results are substantial enough to support a regulatory review or whether that will require the results of another ongoing trial. It said in March in a brief summary of the late-stage trial that Dupixent was associated with a 30% reduction in acute exacerbations of the disease, which is also known as chronic obstructive pulmonary disease (COPD). This potentially added billions to the French drugmaker's growth prospects but also underscored a heavy reliance on its bestseller. Dupixent, approved to treat conditions including asthma and eczema, is being jointly developed with Regeneron. "Within two weeks we saw improvement in lung function and improvement in quality of life," said Naimish Patel, Sanofi head of global development for immunology and inflammation. "And this was also sustained, out to 52 weeks," he added.

Endobronchial Valves: Sustained Improvement in Emphysema

MAY 29 2023

Patients with emphysema treated with one-way endobronchial values showed consistent improvement in lung function after 5 years compared with controls, based on data from 174 individuals.

One-way endobronchial valves demonstrated benefits for patients with severe emphysema over a 12-month period in the EMPROVE trial, according to Gerard J. Criner, MD, of Temple University, Philadelphia, and colleagues. Five-year results from the EMPROVE study were presented here in a poster session at the American Thoracic Society annual conference. The initial EMPROVE trial demonstrated safety and efficacy of the Spiration Valve System (SVS) over 12 months. However, data on the long-term benefits of one-way endobronchial values are limited, the researchers wrote. The valve was designed for use in selected areas of the bronchial airways and features a flexible umbrella that allows air and mucus to clear from treated airways while blocking inspired air flow to areas of the lungs affected by disease, the researchers explained in the poster. Criner and colleagues assessed 172 patients who were randomly assigned to treatment with a one-way valve system (113 patients) or a control group (59 patients). Participants were evaluated at 1, 3, 6, and 12 months, then annually for 5 years. The primary efficacy outcome was lung function, measured by forced expiratory volume per second (FEV1). At five years, the FEV values improved by 0.1098 liters in the treatment group (P < .001). Treated patients and controls experienced decreased FEV at a rate of 0.0440 liters per year from baseline, a significant difference (P < .001). Assuming a steady rate of disease progression, "the treatment group gained approximately 2.5 years of FEV1 improvement immediately following SVS treatment, which was maintained, compared to controls," the researchers noted in their abstract. Serious adverse events were assessed from 6 months to 5 years (352.7 patient-years) for treated patients and from 6 months to 2 years (72.9 patient-years) for controls. Overall, a total of 210 SAEs occurred in the treatment group and 35 occurred in controls, for rates of 0.60 and 0.48, respectively (P = .201). The most common SAEs in the treatment and control groups were COPD exacerbations, pneumothorax, and death. The results suggest that the FEV improvements seen in patients with severe emphysema after one-way endobronchial value placement compared with usual care are enduring after 5 years, with no significant changes in safety, the researchers concluded.

Antiepithelial-derived Cytokines Need Targeting for Asthma

MAY 29 2023

Use of antiepithelial-derived cytokines was of limited benefit for patients with severe asthma who had low eosinophil counts, as indicated by data from a systematic review that included more than 2000 individuals. Several types of antiepithelial-derived cytokines (anti-EDCs) have been studied or approved for patients with severe asthma; however, "we understand very little about the effects for those who are not type 2," said Terence Ho, MD, of McMaster University, Hamilton, Ontario, Canada. The meta-analysis was needed because some clinical trials suggest benefits for patients with type-2 asthma (T2) and patients with non-T2 asthma, but data that compare outcomes are limited, Ho said. If one were to look at just one study, one might think that anti-EDCs would work equally for all patients with severe asthma, he noted. In a study presented at the American Thoracic Society (ATS) 2023 International Conference, Ho and colleagues identified 12 randomized, controlled trials that involved the use of anti-EDCs for a total of 2391 patients. The study population consisted of patients with T2 and non-T2 severe, uncontrolled asthma. T2 asthma was defined as asthma associated with eosinophil levels of ≥300 cells/uL; non-T2 asthma was defined as asthma associated with eosinophil counts of <300 cells/uL. The researchers used a random-effects pairwise analysis to evaluate outcomes in the different patient groups. Outcomes of interest were all-cause mortality, asthma exacerbation rate (AER), change in forced expiratory volume per second (FEV1), serious adverse events, change in blood, sputum, and/or submucosal eosinophil counts, fractioned exhaled nitric oxide (FeNO) level, and immunoglobulin E (IgE) level. Overall, anti-EDCs were associated with a reduced AER among patients with T2 asthma (risk ratio [RR], 0.33) with moderate certainty, but certainty was low for patients with non-T2 asthma (RR, 0.59). Anti-EDCs were significantly associated with improved lung function, as shown on FEV1, for patients with T2 asthma (mean difference with patients with non-T2 asthma: 218.5 mL vs 68.8 mL). Blood eosinophil counts, IgE level, and FeNO level were similarly reduced among both patient groups. The takeaway message for clinicians is not to presume that anti-EDCs will be equally effective for all patients with severe asthma, especially given the cost associated with these treatments, Ho said. More research on the use of anti-EDCs for patients with non-T2 asthma is needed, he said.

Dupilumab Curbs Acute COPD Exacerbations

MAY 29 2023

Dupilumab significantly reduced exacerbations in adults with chronic obstructive pulmonary disease by approximately 30% compared with placebo, based on data from approximately 900 individuals. Chronic obstructive pulmonary disease (COPD) is associated with decreased lung function and increased risk of exacerbations, and previous studies of anti-interleukin-5 biologics have yielded mixed results, according to Surya Bhatt, MD, of the University of Alabama at Birmingham, and colleagues. Dupilumab, a fully human monoclonal antibody, is designed to target receptors for interleukin-4 and interleukin-13, known drivers of type 2 inflammation, the researchers said. In a study known as the BOREAS trial, simultaneously published in the New England Journal of Medicine and presented at the 2023 American Thoracic Society International Conference in Washington, DC, the researchers randomized 468 COPD patients to 300 mg of dupilumab and 471 to a subcutaneous placebo injection once every 2 weeks. The patients met criteria for type 2 inflammation, defined as blood eosinophil counts of at least 300 per microliter, and demonstrated an increased risk of exacerbations despite a history of triple inhaler therapy. The patients ranged in age from 40 to 80 years (mean age 65 years) and had physician-diagnosed COPD for at least 12 months. Approximately two thirds were men, and 84% were White. The study population overall had an average of 2.3 moderate or severe COPD exacerbations in the past year, and 30% were current smokers. The primary outcome was the annualized rate of COPD exacerbations, which was 0.78 in the dupilumab group vs. 1.10 in the placebo group, (rate ratio 0.70, P < .001). Secondary endpoints included change in prebronchodilator forced expiratory volume in 1 second (FEV1). This change was significantly greater from baseline to 12 weeks in the dupilumab group compared with the placebo group (mean of 0.160 L vs. 0.077 L, P < .001); this difference continued at 52 weeks. Other secondary endpoints examined quality of life using St. George’s Respiratory Questionnaire (SGRQ) and the Evaluating Respiratory Symptoms in COPD (E-RS: COPD). On these measures, lower scores indicated better quality of life and less severe symptoms, respectively. SGRQ total scores improved by 4 or more points in 51.5% of dupilumab patients and 43.1% of placebo patients, and the least squares mean difference in the dupilumab group vs. the placebo group from baseline to 52 weeks was -3.4 (P = .002). The least squares mean difference in E-RS: COPD total score from baseline to 52 weeks in dupilumab patients vs. placebo patients was -1.1 (P = .001).

Sublingual Immunotherapy Stops Onset and Worsening of Asthma

MAY 29 2023

The EfficAPSI study showed with real-world data that sublingual immunotherapy (SLIT), or "desensitization," reduces the risks for asthma onset and the worsening of asthma symptoms for patients with allergic rhinitis. The research was presented at the 18th French-language allergy conference in Paris. These results confirm that allergen immunotherapy (AIT), or "desensitization," is indeed an etiologic treatment of this allergic condition. SLIT encompasses personalized solutions created for an individual specifically for allergies to dust mites, grass, birch, cats, and so on. These preparations are commonly used by allergy specialists when establishing an AIT treatment plan. The pharmacoepidemiologic EfficAPSI study is the largest retrospective, real-world, longitudinal cohort study ever carried out regarding liquid SLIT using data stored in the French National Health Data System (SNDS). The primary objective of the study was to evaluate the real-world impact of liquid SLIT on the onset and worsening of asthma for patients with allergic rhinitis and to evaluate the impact of sublingual treatments on public health. A cohort analysis of patients treated with SLIT and control patients treated for allergic rhinitis with or without treatment for asthma was carried out. The patients treated with SLIT for at least 2 consecutive years were anonymously selected from the SNDS using the Stallergenes Greer prescription database. In all, 99,538 patients who received SLIT were compared with 333,082 control patients (those who had received treatment for allergic rhinitis without taking SLIT). Participants were stratified according to their treatment history for asthma and were paired using a propensity score to minimize comparison bias.

Tests Clear Recalled Philips Sleep Apnea Machines of Health Risks: Company

MAY 29 2023

Dutch medical devices maker Philips said that independent tests have shown that the use of its respiratory devices involved in a major global recall did not cause health risks for patients. Philips said "rigorous testing" by external parties on the range of DreamStation machines used to treat sleep apnoea showed positive results, confirming preliminary results released last year. "We are very pleased with these results, it is very important for patients to know that the use of the devices did not lead to a health risk", Philips Chief Executive Roy Jakobs said. "It proves we have worked with a safe product, even though it might degrade." Amsterdam-based Philips has been grappling with the fallout of the global recall in June 2021 of millions of respirators used to treat sleep apnea over worries that foam used in the machines could become toxic.

Masimo Announces Major Expansion of the HEOS® Platform

MAY 24 2023

Masimo announced the global expansion of the HEOS platform, enabling an always-on connection to the Masimo Health secure cloud for four million devices and empowering consumers with an enhanced health tracking experience. This software upgrade allows Masimo’s cutting-edge devices and secure cloud solution to seamlessly integrate with HEOS-enabled sound bars, wireless speakers, amplifiers, and receivers from Denon, Marantz, and Definitive Technology worldwide – including the U.S., Canada, United Kingdom, Japan, and Australia, with more countries going live later this year.

Mercury Medical Awarded Respiratory Therapy Products Agreements with Premier, Inc.

MAY 8 2023

Mercury Medical has been awarded a group purchasing agreement for Resuscitation Devices and Medication Delivery and Bronchial Hygiene with Premier, Inc. Effective May 1st, 2023, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for Respiratory Therapy Products.

John Gargaro MD, President and CEO at Mercury Medical, states: “This is a huge milestone that now allows Premier members access to our clinically differentiated resuscitation devices, medication delivery and bronchial hygiene devices. Our CPR2+ manual resuscitation bag, included in the contract, is a prime example of innovation aimed at helping hospitals maximize their lung volume protection strategies. These new contracts assist Premier members to achieve Mercury Medicals vision, To Save Lives.”

Respiratory Therapy Products Agreements include #PP-NS-1759 Resuscitation Devices and #PP-NS-1749 Medication Delivery and Bronchial Hygiene.

Premier, Inc. is a leading healthcare improvement company, uniting an alliance of more than 4,400 U.S. hospitals and health systems and approximately 250,000 other providers and organizations to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost.

Vitalograph Reveals their Most Powerful, Versatile and Connected Handheld Spirometer Ever

MAY 1 2023

The In2tive™ spirometer is a powerful and versatile portable respiratory diagnostic solution that enables detailed, point of-care spirometry testing wherever it is needed, all seamlessly connected to the hospital network. It features a 10,000-test subject memory, and also has a detachable flow head, which makes it easier to view data during testing while creating distance between subject and tester. In2itive allows for an elegant bi-directional flow of information via wireless or USB connection to the EMR as well.

The In2itive offers multiple spirometry testing options, such as FVC, SVC and bronchodilator responsiveness, all in compliance with ATS/ERS 2019 Guidelines. V-Core technology, comprising a core of air capillaries engineered from stainless steel, makes Vitalograph flow heads very accurate and stable (even at low flow rates) and extremely robust and long-lasting. No moving parts means there is little opportunity for breakages and makes them a practical and adaptable choice where frequent spirometry testing is required.

Troy Pridgeon, North America EVP Operations and Sales says: “The In2tive brings Vitalograph quality and test accuracy to a device that is much more powerful and more portable than ever before. It’s rechargeable and lightweight and it has the largest screen of any handheld spirometer on the market. Its bi-directional EMR connectivity continuously synchronizes respiratory assessment needs and spirometry results, maximizing the efficiency of healthcare decisions, from anywhere within a healthcare setting.”

New Device Launched to Monitor Oxygen Concentration

April 26 2023

Maxtec, a global leading manufacturer of respiratory care products, is excited to announce the launch of its newest device, the MaxO2ME+p. This device is designed to monitor both oxygen concentration and pressure during bubble CPAP therapy, a care method for infants to treat respiratory distress syndrome (RDS) or other respiratory conditions. This device will help provide clinicians with the critical data they need to deliver effective care to their patients. The MaxO2 ME+p is a state-of-the-art device that helps healthcare providers monitor the oxygen concentration and pressure of the air delivered to neonatal patients during bubble CPAP therapy. By providing real-time, accurate data on oxygen concentration and pressure, the MaxO2 ME+p helps healthcare providers ensure that their patients are receiving the correct therapy. "We are thrilled to introduce the MaxO2 ME+p to the market," said Kathy Ouellette, President and CEO of Perma Pure Group (consisting of Maxtec and Perma Pure). "This device is the result of our ongoing commitment to developing innovative medical devices that make a real difference in the lives of patients and healthcare providers. We believe that the MaxO2ME+p is a game-changer in the field, and we are excited to see the impact it will have on patient care." Maxtec is dedicated to providing clinicians with the tools they need to deliver effective care to their patients. The MaxO2 ME+p is the latest example of this commitment, and Maxtec is proud to bring this product to market as they continue to pursue a mission of helping the world to Breathe Easier and Be Healthier.

Masimo Announces FDA Clearance of the Rad-G with Temperature

April 18 2023

Masimo announced that the Rad-G with Temperature has received FDA 510(k) clearance. Rad-G with Temperature is a rugged, versatile, handheld monitor that provides clinically proven SET® pulse oximetry, respiration rate from the pleth (RRp®), and other important parameters alongside non-contact infrared clinical thermometry. With its long-lasting rechargeable battery, robust rubber casing, light weight, and the added convenience of integrated noninvasive forehead thermometry, Rad-G with Temperature makes it easier for care teams to quickly measure vital signs using a single, compact, portable device and make informed decisions anywhere patient assessment is needed. Rad-G with Temperature is designed for use in a variety of settings, including physicians’ offices, outpatient services, urgent care facilities, wellness clinics, and in first-responder scenarios, both indoors and in the field. Joe Kiani, Founder and CEO of Masimo, said, “With Rad-G, we set out to create an accessible, high-quality care solution that could be used in a multitude of care settings to serve the five billion people on our planet that to date have not had access to pulse oximetry, let alone SET pulse oximetry. With the addition of temperature measurements, Rad-G is more versatile than ever, streamlining the assessment of multiple key vital signs. Having a product that is light, small, multifunctional, and ‘accurate when you need it most’ is crucial, and Rad-G was designed to be just that. With this FDA clearance, Rad-G with Temperature can now be deployed across the U.S., in addition to many other parts of the world, helping support clinicians in almost any care scenario.” The infrared thermometry offered by Rad-G with Temperature provides a host of benefits. Rad-G’s thermometer is non-contact and does not require probe covers or other disposable accessories. Its integration into the Rad-G platform eliminates the need for clinicians to locate a separate clinical thermometer to take body temperature measurements and ensures that many people can be seamlessly and efficiently screened for temperature, with one-touch operation, alongside oxygen saturation, respiration rate, and more, in the same session, using a single device. Designed from the start to maximize portability and battery life, Rad-G’s rechargeable battery provides an impressive 24 hours of operational use between charges – allowing clinicians to work in transport, emergency, and other challenging scenarios with confidence that the device will continue to function hour after hour. First developed in partnership with The Bill & Melinda Gates Foundation as a spot-check device for use in pneumonia screening, Rad-G with Temperature originally launched outside the U.S. Since its introduction in Europe, more than 100 global customers have adopted the device to help them assess patient status in a variety of care settings. Among other care scenarios, the National Health Service (NHS) England, which provides the majority of healthcare in England, uses the technology to support primary care assessments of unwell children in physician’s offices across the country. In a survey of 109 NHS England clinicians whose primary care facilities were using more than 4,000 Rad-G with Temperature devices, 85% of respondents scored Rad-G with Temperature as “Quite Easy” or “Very Easy” to use. SpO2 and PR monitoring on Rad-G is provided using clinically proven Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in over 100 independent and objective studies to outperform other technologies. SET is estimated to be used on more than 200 million patients a year3 and is the primary pulse oximetry at 9 of the 10 hospitals that top the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.4 With Masimo SET®technology in Rad-G, clinicians have access to accurate pulse oximetry measurements in the palm of the hand. In addition to temperature measurements and Masimo SET® oxygen saturation (SpO2) and pulse rate (PR), the same SpO2sensor can be used to monitor respiration rate from the plethysmograph, with RRp. Difficulty breathing and fever are generally considered two of the earliest signs of patient deterioration, and Masimo believes that the availability of RRp and thermometry on Rad-G may play a role in assisting clinicians and public health officials as they seek to combat numerous types of illnesses, including pneumonia and other respiratory viruses. Rad-G with Temperature can be used with a variety of reusable and single-patient use sensors. The universal direct-connect Rad-G reusable sensor, indicated for monitoring adult, pediatric, and infant patients, helps to eliminate the need to stock and carry multiple sensor types, increasing the device’s versatility and ease of use, especially in more challenging field environments. Rad-G with Temperature is also compatible with the vast portfolio of Masimo single-patient-use adhesive sensors—including Masimo RD SET sensors, which offer best-in-class accuracy specifications of 1.5% in conditions of motion and no motion—ensuring clinicians can customize their setup based on the unique needs of each care setting. In addition, Rad-G is designed to work reliably on all people, regardless of skin tone, from neonates and babies to elderly patients.

ECO MEDICS-ECO PHYSICS, INC. to Exhibit at ATS 2023 International Conference

April 18 2023

ECO PHYSICS, INC. is once again going to be an exhibitor at the American Thoracic Society’s International Conference. We are proud to be welcomed back to ATS 2023 and excited for a safe return to the live, in-person conference. Last year over 8,100 professionals attended the show in San Francisco, CA. This will be ECO PHYSICS, INC.’s 23rd straight year as an exhibitor. The annual ATS International Conference is the home of pulmonary, critical care, and sleep professionals, from those in the earliest stages of their careers to those whose research or strides in clinical care have gained them international recognition. In years past, on average 10,000 of these respiratory professionals chose to attend, present, and learn about the latest advances. This year’s Conference will be held May 19-24, in Washington, DC. ECO MEDICS offers a broad range of research Pulmonary Function Testing (PFT) & Spirometry capabilities including Lung Clearance Index (LCI), Forced Expiratory Volume in 1 second (FEV1), and Forced Vital Capacity (FVC). The EXHALYZER D performs sensitive nitrogen multiple breath washout (N2MBW) measurements, revealing detailed information on the small airways. The Analyzer CLD 88sp instrument is utilized for exhaled nitric oxide (FeNO) and nasal nitric oxide (nNO) measurements.

Beyond Air Appoints New Chief Medical Officer

March 23 2023

Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, announced the appointment of Dr Jeff Myers as Chief Medical Officer of the Company, effective March 27, 2023. Dr Andrew Colin, the Company’s incumbent Chief Medical Officer, has transitioned to the role of Senior Medical Director Global Clinical Leadership and will remain an integral part of the Beyond Air team. Dr Colin will be working closely with Dr. Myers to ensure a seamless transition. Dr Myers joins Beyond Air with nearly 15 years of leadership experience as a biopharmaceutical executive overseeing clinical development, clinical operations, and regulatory affairs. Prior to industry, Dr Myers was a cardiothoracic surgeon for nine years, most recently at Massachusetts General Hospital. “We are excited to appoint Dr Myers as our Chief Medical Officer. Being an accomplished cardiothoracic surgeon with success at several healthcare companies in medical capacities provides Dr Myers with the attributes Beyond Air needs as we move forward with developing the pipeline for our revolutionary LungFit platform,” stated Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “I want to thank Dr Colin for his commitment to Beyond Air and look forward to working with him in his new role.” “I am excited to join Beyond Air’s highly accomplished team of scientists, engineers, and investigators. This team has successfully advanced development of the Company’s pipeline, including announcing the first FDA-approved product for the LungFit platform in mid-2022. I look forward to building upon this momentum as we continue to harness the power of nitric oxide to treat a broad variety of indications,” commented Dr Myers. Dr Myers’ previous leadership responsibilities include overseeing clinical development, clinical operations, business development, medical affairs, and implementing regulatory strategies in the US and abroad. Previously, he was the Chief Medical Officer for Revolo Biotherapeutics, initiating clinical trials in the US and Europe before leaving to become the CEO of Bioceptive where he continues to serve as a member of the Board of Directors. Dr Myers also served as the Chief Medical Officer for Portola Pharmaceuticals where he was instrumental in the acquisition by Alexion Pharmaceuticals, and Vice President, Medical and Regulatory Affairs, at SteadyMed Therapeutics. Prior to beginning his career in biotechnology, he was a practicing congenital cardiac surgeon and served as the Chief of Pediatric Cardiac Surgery at Tulane University and Massachusetts General Hospital with appointments to Tulane and Harvard Medical Schools. He is passionate about developing novel, first-in-class therapies that significantly improve the lives of patients. Dr Myers began his work with inhaled nitric oxide in pursuit of his PhD at Georgetown University and is thrilled to join Beyond Air and its pursuit of the potential of these therapies across multiple indications in critically ill patients. In connection with the appointment of Dr Myers, the Company granted Dr Myers an inducement stock option award and restricted stock unit award as inducements material to Dr Myers’ entering into employment with the Company in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The Inducement Option is being granted effective as of March 27, 2023 and is exercisable for the purchase of 50,000 shares of the Company’s common stock, at an exercise price equal to the last reported sale price on Nasdaq on March 27, 2023. The Inducement RSU for 50,000 shares of the Company’s common stock is being granted effective as of March 27, 2023. The Inducement Awards were approved by the independent compensation committee of the Board in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The Inducement Option has a ten-year term and will vest over a four-year period, with 25% of the shares underlying the stock option award vesting on the first anniversary of the date of grant and annually thereafter in three equal installments, subject to Dr Myers’ continued service with the Company through the applicable vesting dates. The Inducement RSU will vest over a five-year period, with 20% vesting in December 2023 and 20% annually thereafter. The Inducement Awards are subject to the terms and conditions of the Company’s 2013 Equity Incentive Plan.

Companies Unite for Pulmonary Function Testing Series

March 14 2023

Combining decades of scientific expertise and experience in respiratory diagnostics, Vitalograph and Morgan Scientific have come together to create the most advanced series of Pulmonary Function Testing systems. The state-of-the-art innovative Pulmonary Function Testing (PFT) hardware from Vitalograph, combined with the most comprehensive enterprise PFT software, ComPAS2 from Morgan Scientific will revolutionize Pulmonary Function Testing as we know it. For clinicians, this means having an accurate and reliable point-of-care and laboratory testing system. Ease of testing for both clinician and patient is a hallmark of the new products, with pressure-less gas delivery and instant test quality feedback, resulting in research-grade accuracy and repeatability. Clinicians can be assured that results meet stringent regulatory standards and also meet the new gas pathway directive. The Vitalograph Morgan PFT range is designed to grow with your clinic and respond to the complex respiratory diagnostic needs of all secondary care health facilities. The ComPAS2 software allows seamless workflow integrations that work with the dynamics of each unique setting, be it with a single device, a mult-device lab, or a complex hospital system with numerous departments. The ComPAS2 Task Manager makes interpreting and billing for a PFT as easy as answering an email, with its inbox design and integrated billing interface. ComPAS2 and its Task Manager, coupled with Vitalograph’s expertise in respiratory diagnostic hardware, enables you carry out complete respiratory diagnostics, wherever they are needed. Commenting on the partnership Vitalograph CEO, Frank Keane said: “We are delighted to bring together our combined respiratory diagnostic expertise to create what we believe is the world’s most comprehensive PFT range. Our vision is to have a real impact on the effective management of respiratory diseases and ultimately improve patients’ lives.” While Gareth Morgan, President from Morgan Scientific added, “Morgan Scientific working in partnership with Vitalograph is an ideal alliance. Our two family-owned companies have a combined legacy summing more than 100 years of providing the highest quality pulmonary diagnostic solutions to the world. What we have been able to accomplish with regard to new software and hardware innovations, amidst the challenges of a pandemic, is simply amazing and speaks to the strength of the relationship. I have never been more excited about what we have to offer and how it will help to reset the gold standard in the industry. Furthermore, we couldn’t be more aligned with our approach to customer care and truly listening to our users.”

Vitalograph Announces US Sales Agreement with NIOX

March 9 2023

Vitalograph announced a US sales agreement with NIOX , the world-leading point-of-care fractional exhaled nitric oxide (FeNO) testing device.

“At Vitalograph, we constantly work to push the boundaries of innovation through our high-quality medical devices. Our devices are found in healthcare and occupational health settings worldwide, where they are used to aid in the diagnosis and management of respiratory conditions,” said a news release. Executive Vice President of Vitalograph’s Sales and Operations for North America, Troy Pridgeon, said: “This is a very convenient and beneficial opportunity to bundle the NIOX FeNO testing products into our own portfolio of spirometers and screening devices. Vitalograph is proud to include this important testing tool as an option to further enhance the range and sophistication of our available solutions.” Physicians worldwide use the market-leading NIOX products to help improve asthma diagnosis and management. NIOX accurately assesses airway inflammation at the point-of-care, helping improve patient outcomes. NIOX’s Senior Vice President, Americas and Research Business, Tom Scaccia, said: “NIOX is the gold standard point-of-care FeNO testing device and an accurate, reliable, and straightforward technology trusted by thousands of healthcare professionals to help manage their patient’s asthma. A US sales agreement with Vitalograph furthers our goal of ensuring that the millions of asthma patients in the US have access to this important device.” NIOX products are used to improve asthma patient outcomes and are indicated for use in those aged 7 years and older in the U.S. NIOX technology is based on the discovery that patients with Type 2 airway inflammation (previously known as allergic or eosinophilic inflammation) have elevated levels of nitric oxide in their exhaled breath. Corticosteroid therapy has been proven to reduce airway inflammation and FeNO levels. Research has shown that up to 84% of asthma patients have Type 2 airway inflammation, which is particularly associated with exacerbations. By measuring the concentration of FeNO, NIOX enables clinicians to evaluate airway inflammation in asthma patients, aiding diagnosis and reducing exacerbations.

Study Finds Masimo PVi Reliably Predicted Fluid Responsiveness in Young Children Undergoing Neurosurgery

March 9 2023

Masimo announced the findings of a prospective study published in Pediatrics International in which Dr. Ya-Fei Liu and colleagues at Peking University First Hospital in Beijing evaluated the ability of noninvasive, continuous Masimo PVi, alongside other dynamic parameters, to predict fluid responsiveness in children 1-3 years old who were undergoing major neurosurgery. The researchers concluded, “Volume-based PVi and ∆Vpeak [respiratory variation in aortic blood flow peak velocity] showed acceptable reliabilities for fluid responsiveness prediction in young children undergoing major neurosurgery, while pressure-based SVV [stroke volume variation] using FloTrac/Vigileo, Eadyn [dynamic arterial elastance], and PPV [pulse pressure variation] [did] not.” Noting that dynamic variables have been shown to predict fluid responsiveness more accurately than static variables, and the critical importance of optimizing fluid administration in pediatric surgical patients, the researchers sought to evaluate and compare the performance of a variety of dynamic variables in such a scenario. The parameters evaluated were noninvasive, continuous PVi (pleth variability index, obtained from the photoplethysmographic waveform measured by fingertip pulse oximetry sensors and, in this study, the Masimo Radical-7 Pulse CO-Oximeter), ∆Vpeak (obtained intermittently by Doppler echocardiography), SVV (measured by the Edwards Lifesciences FloTrac/Vigileo system), PPV (obtained from the peripheral arterial pressure waveform), and Eadyn (an index of arterial load). The researchers enrolled 60 patients, aged 1-3, who were undergoing major neurosurgery with mechanical ventilation set at a fixed tidal volume of 8 ml/kg. Following induction of anesthesia, during a hemodynamically stable period, the patients were administered 10 ml/kg of Ringer’s lactate solution, over 10 minutes; all variables were measured before and within five minutes of fluid loading. Patients with an increase in cardiac index (CI) of 10% or more were identified as a fluid responder. (CI was defined as stroke volume index multiplied by heart rate.) The researchers identified 26 of the 60 patients as fluid responders. They found that baseline PVi showed “fair diagnostic accuracy” for CI-fluid responsiveness, with an area under the receiver operating characteristic curve (AUROC) of 0.775, p < 0.001. A baseline PVi cutoff value of 15% predicted CI-fluid responsiveness with 77% sensitivity and 68% specificity. Baseline ∆Vpeak was an “excellent predictor” of a CI increase, with AUROC of 0.982, p < 0.001, and a cutoff value of 9.6%. However, ∆Vpeak, which is dependent on the timing of echocardiograms, can only be obtained intermittently; the authors also note, as a practical drawback, that the limited availability of echocardiographic professionals “decreases its wide use in routine clinical settings.” The researchers found the other methods were either “poor” or “were not” predictors. The researchers concluded, “Volume-based PVI and ∆Vpeak showed acceptable reliabilities to predict fluid responsiveness, defined by a CI increase, after anesthesia induction in mechanically ventilated young children undergoing major neurosurgery. However, pressure-based FloTrac/Vigileo-derived SVV, Eadyn, PI, PPV, and SVIc were not or [were] poorly reliable predictors. PVi’s noninvasiveness, continuity and acceptable predictability for fluid responsiveness could make it a potential aid in evaluating hemodynamic status, facilitating fluid administration, and developing optimal fluid management protocols in young children undergoing neurosurgery.” Joe Kiani, Founder and CEO of Masimo, said, “From its inception, Masimo has focused on developing technologies that improve outcomes for the very youngest and most fragile of patients. This latest study on PVi – the second we are reporting on just this week! – adds to the body of evidence that PVi can help clinicians predict fluid responsiveness.” In the U.S., PVi is FDA 510(k) cleared as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

React Health Acquires Product Line

february 24 2023

Ventec Life Systems, Inc., a wholly owned subsidiary of React Health Holdings, has acquired the assets of the Invacare Respiratory Product line following Invacare’s exit in November of 2022. “With this acquisition, React Health is well positioned to continue to support the end-to-end care of patients with cardiology, sleep, and respiratory illnesses, in partnership with physicians and providers of diagnostic and needed therapies. Invacare’s respiratory line provides a perfect complement to React’s current product offering and shows React Health’s commitment to providing quality products to support the needs of the sleep and respiratory space.” said Tom Pontzius, President, Operations, React Health. Integration and transition of the Invacare products has begun. While there are many steps and tasks at hand, React Health will continue to update its customers on the progress and timing of the release of the acquired products, components, and services in the coming days. Clint Geffert, President of Commercial Operations at React Health adds, “The addition of the Invacare product line to React Health’s Respiratory offering further strengthens our commitment to providing a full complement of products and services to treat chronic disease states in the home setting.  We look forward to welcoming Invacare’s customers and patients to the React Health family.” “React Health is excited to bring the Invacare Respiratory product line back to market. Invacare has been synonymous with quality for years. The respiratory products and services have been very well received in the marketplace and we look forward to continuing the legacy we take over.” said Pontzius.

New Study Evaluates the Utility of Masimo ORi in Reducing Hyperoxemia During Laparoscopic Gastrectomy

FEBRUARY 22 2023

Masimo announced the findings of a prospective, double-blinded, randomized controlled study published in Medicine in which Dr. Jin Hee Ahn and colleagues at the Sungkyunkwan University School of Medicine in Seoul, Korea, evaluated the ability of Masimo ORi to assist clinicians in guiding supplemental oxygenation during elective laparoscopic gastrectomy surgery. The researchers found that the combination of ORi and standard of care oxygen saturation (SpO2) monitoring reduced hyperoxemia compared to SpO2 monitoring alone. ORi, available outside the US since 2014, is a noninvasive and continuous parameter intended to provide additional insight into a patient’s oxygen status under supplemental oxygen. Enabled by the multi-wavelength rainbow Pulse CO-Oximetry platform, ORi is provided alongside SpO2 measured by clinically proven Masimo SET pulse oximetry. Noting that the use of supplemental oxygen during general surgery increases the risk of hyperoxemia, the researchers sought to evaluate whether noninvasive, continuous ORi might improve clinicians’ ability to detect hyperoxemia, since SpO2 monitoring alone cannot monitor beyond 100% saturation, and since arterial blood gas analysis has the disadvantages of being invasive and giving intermittent, delayed results. To test their hypothesis, the researchers randomly allocated 62 adult patients scheduled for elective laparoscopic gastrectomy into two groups, one whose fraction of inspired oxygen (FiO2) during anesthesia was guided by ORi and SpO2 monitoring (the ORi-SpO2 group, n=30), and a control group whose FiO2 was guided by SpO2 monitoring alone (the SpO2 group, n=32). Patients in both groups were monitored with Masimo Radical-7 Pulse CO-Oximeters with rainbow sensors. In addition to Masimo ORi and SET SpO2, Masimo PVi (pleth variability index) was monitored as part of goal-directed fluid management. In the ORi-SpO2 group, FiO2 was adjusted to maintain ORi > 0 and < 0.3, which was evaluated every 2 to 3 minutes throughout surgery. In the SpO2 group, FiO2 was adjusted to maintain SpO2 ≥ 98%, similarly evaluated every 2 to 3 minutes. To assess the incidence of hyperoxemia, the clinicians recorded the arterial partial pressure of oxygen (PaO2), measured using an ABL-90 FLEX Plus blood gas analyzer, before surgical incision and one, two, and three hours after surgical incision. Hyperoxemia was defined as PaO2 ≥ 100 mmHg and severe hyperoxemia as PaO2 ≥ 200 mmHg. The researchers found that one hour after surgical incision, PaO2 was higher in the SpO2 group (250.31 ± 57.39 mmHg) than in the ORi-SpO2 group (170.07 ± 49.39 mmHg) (p < .001), and remained consistently higher in the SpO2 group than in the ORi-SpO2 group over time (p = .045). The rate of severe hyperoxemia was higher in the SpO2 group (84.4%) than in the ORi-SpO2 group (16.7%) 1 hour after incision (p < .001). The researchers concluded, “[I]ntraoperative hyperoxemia was reduced when FiO2 was adjusted based on the combination of SpO2 and ORi compared with SpO2 alone in patients undergoing laparoscopic gastrectomy.” ORi has not yet received FDA clearance and is not available in the United States.

You Should Be Testing VO2 Max in Your Older Patients

FEBRUARY 15 2023

Physicians routinely monitor cholesterol, blood pressure, and glucose levels to get a clearer picture of their patients' overall health. But a group of experts argues that having an accurate read of a person's ability to absorb oxygen during peak exertion ― VO2 max ― is just as important. Once the focus of cyclists and other elite athletes, VO2 max has in recent years caught the attention of geriatricians, who have linked the measure to maximum functional capacity ― an umbrella term for the body's ability to perform aerobic exercise. "Function is prognostic of mortality," said Daniel E. Forman, MD, FAHA, FACC, professor of medicine and chair of the Section of Geriatric Cardiology at the University of Pittsburgh Medical Center. "If you aren't looking at that, you're missing the boat.” Although cardiopulmonary exercise testing (CPET) remains the gold standard for assessing VO2 max, Forman said clinicians often overlook CPET because it is old. As a person ages, the amount of physical activity they need to stay fit varies, depending on their genes, their health, and their fitness history. Measuring VO2 max can help doctors better prescribe physical activity, both with regard to specific exercises and for how long, Claudio Gil Araújo, MD, PhD, dean of research and education at the Exercise Medicine Clinic at CLINIMEX in Rio de Janeiro, Brazil, said. The test can also measure progress. "Guidelines talk about how much exercise you should do every week, but it's somewhat misleading because the health outcomes are much more linked to physical fitness than the amount of exercise you do," Araújo said. Treating a patient with hypertension requires an individualized approach. "The same thing is true with exercise," he said.

React Health adds New V-Com PAP Comfort Accessory to its PAP Offering

February 13 2023

React Health announced it has entered into a distribution agreement with SleepRes, LLC to provide the recently launched V-Com with new PAP orders in the United States. The V-Com, which is placed between the CPAP mask and the CPAP hose, is engineered to reduce inspiratory pressure and flow to provide comfort with minimal to no reduction in expiratory pressure (EPAP). Introduced in June 2022, V-Com has gained early acceptance with many key thought leaders in the field and is poised to disrupt the way PAP therapy and comfort are approached. “React Health is committed to providing innovative options to improve comfort and patient tolerance to PAP therapy. The V-Com is a novel approach that is focused on solving the adherence issues that the industry has struggled with due to patients not being able to tolerate their PAP” said Clint Geffert, President, Commercial Operations, for React Health. “As a manufacturer, we are in a unique position to complement the efforts that our DME and Physician partners utilize daily to improve patient compliance. Our relationship with V-Com is an example of this. We know when patients are more comfortable, they are more likely to continue therapy.” “I have experienced the V-Com myself and believe it is a real difference maker for patients starting CPAP,” said Robert Miller, Vice President of Sleep Therapy, Apria Healthcare. “The fact that a manufacturer has chosen to make V-Com available for their patients is tremendous value-add. I congratulate React Health.” In the cover story for the December 2022 edition of Sleep Review magazine titled, “A Potentially Huge CPAP Pressure Mistake” early physicians and engineers in the field suggest that current CPAP devices are harder to tolerate than 20 years ago. They attribute this difficulty tolerating therapy to IPAP which the V-Com mproves. “The V-Com’ s comfort comes from the IPAP being less than EPAP,” said Dr Krishna Sundar, Chief of Medicine at the University of Utah. “This new concept of IPAP less than EPAP appears to have advantages beyond comfort. It is causing all of us in the field to rethink treatment.” “Comfort is an ethical matter,” said William Noah, MD, CEO of SleepRes, LLC. “If an intervention provides comfort for a difficult therapy, and does not adversely affect the therapy, then I believe you have an obligation to offer that intervention. We applaud the leadership of React Health for being so patient-focused and look forward to working with them.” “One of the best solutions we’ve seen is to change the pressure transitions in the devices, and in our partnership with V-Com we look forward to making that happen.” said Geffert.

VERO Biotech’s Second Generation GENOSYL Delivery System Receives FDA Approval

february 3 2023

VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of its innovative second generation GENOSYL Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the operating room setting. Second generation GENOSYL is now the first and only device for iNO delivery that is approved for use in both rebreathing and non-rebreathing anesthesia methods, improving patient care, saving money for the hospital, and reducing environmental pollution from waste anesthetic gas. The advantages of rebreathing anesthesia have made this method the standard of care for anesthesia administration in the OR setting. There is a significant advantage in patient care, helping patients retain moisture and body heat. The loss of body heat and moisture can be key complications of anesthesia faced by every patient, especially smaller patients. Rebreathing also allows lower fresh gas flows, which reduces costs for the hospital as well as environmental pollution from anesthetic gas waste. The expected benefits of the second generation GENOSYL as approved for rebreathing anesthesia include the following: Ability to use rebreathing anesthesia: lower gas flows, i.e., less use of costly anesthetic agents and savings for the hospital; increased patient comfort (by preserving patient body temperature and moisture); treamlined process of care: seamless iNO delivery from the ICU through surgery to post-operative care, resulting in process and workflow improvements for the health care organization that reduce overall cost to the hospital; et and forget: allows anesthesiologists to continue to use rebreathing anesthesia and therefore could prevent potentially dangerous, cumbersome, and time- consuming workarounds; educed environmental impact of anesthesia delivery: reduction in release of anesthetic to the environment. “Second generation Genosyl DS has proven to be the only iNO delivery system capable of accurately delivering iNO with an anesthesia machine under rebreathing conditions, enabling low flow anesthesia with all its benefits,” commented Mark Twite, MD, Director of Pediatric Cardiac Anesthesia, Children’s Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado. “Anesthesia providers can now simply set the iNO dose without adjusting fresh gas flow or anesthetic agent. This decreases provider distractions, maintains focus on the patient, and facilitates the transition of care between the ICU and OR for ventilated patients,” he added. “We believe this new indication for our second generation device will now provide significant benefits to the anesthesiology and surgical care communities whose patients require inhaled nitric oxide in the operating room setting,” said Brent V. Furse, CEO and President, VERO Biotech. “We have addressed an unmet need in facilitating rebreathing anesthesia, a further demonstration of our continuous commitment to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face,” he added. It is important to note the FDA approval of the GENOSYL DS for use with rebreathing anesthesia in the operating room setting is for the second generation device. The recently approved third generation GENOSYL DS has not been tested with rebreathing anesthesia. VERO Biotech is currently in the process of conducting similar validations and expect to have the data available Q1-2023. GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the US Food and Drug Administration (FDA). Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension. Unlike tank-based systems, GENOSYL DS generates and delivers iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify clinical workflow.

Siemens Healthineers and Unilabs launch strategic partnership


Siemens Healthineers, a leading medical technology company, and Unilabs, a leading diagnostic services provider, announced a multi-year agreement valued at over €200 million. Unilabs has invested in Siemens Healthineers’ top-notch technology and will acquire more than 400 laboratory analyzers to further improve its laboratory infrastructure to offer an unparalleled service to its customers. “Delivering the best possible patient care is at the heart of everything we do, and we will continue to invest in the latest technology to further boost our services,” said Michiel Boehmer, Unilabs’ CEO. “Our CARE BIG mantra is driving us in our quest to build the most-digitally driven diagnostics group – enabling better decisions for a healthier tomorrow.” Under this agreement, Unilabs will continue modernizing its healthcare infrastructure across its network to improve customer service and quality, and thereby improve patient health. The solutions Siemens Healthineers provides will enhance Unilabs’ laboratory operations, throughput, and clinical equivalence across its testing network. In the first years, Siemens Healthineers will install high- and mid-volume immunoassay and clinical chemistry analyzers, including the Atellica Solution and Atellica CI 1900, sample handlers, haemostasis analyzers, and automation solutions. "Siemens Healthineers is uniquely positioned to add value through a portfolio of products that work in harmony to scale technology, especially as testing demand grows,” said Sharon Bracken, Head of Diagnostics for Siemens Healthineers. "Our solutions help on many levels. They can improve cost savings and profitability through integrated reagents and consumables, deliver sophisticated intelligence software for better data analytics, and reduce unnecessary workflow friction with intuitive system user interfaces. We look forward to how our collaboration with Unilabs, along with its expanded investment in Siemens Healthineers technology, will benefit the company’s laboratory operations and patient care for years to come."

Flu, RSV on Decline, but COVID Deaths Persist


Respiratory illness levels in the U.S. have declined so much in recent weeks that they are approaching numbers usually seen during non-flu season. Just 3% of flu tests are coming back positive, according to the CDC’s weekly Fluview report. Case counts for respiratory syncytial virus (RSV) emergency department visits are now below summertime levels. Both illnesses raged in record-shattering fashion just a couple of months ago. “This flu season started really early because there were so many children with zero experience with flu, common colds, and RSV,” David Celentano, ScD, chair of epidemiology at Johns Hopkins Bloomberg School of Public Health, said. Data is now pointing to what may amount to simply an early peak for flu and RSV. About 25 million people in the U.S. have had the flu this year and 17,000 people have died of it. The once record-setting hospitalization rate for the flu has fizzled so much that this season may finish up below average for hospitalizations, the CDC projected. The agency said this year’s flu vaccine has been very effective against circulating strains.

Comorbidities and the Prognosis of Chronic Obstructive Pulmonary Disease


Strict control of comorbidities in patients with chronic obstructive pulmonary disease decreases exacerbations, morbimortality, and avoids readmissions. An increasing number of women have the disease, which progresses differently in women than in men and even has different comorbidities. "Comorbidities in patients with chronic obstructive pulmonary disease are more common in older adults, in those with more advanced pulmonary disease, and in those that are hospitalized for an acute exacerbation," said Belén Alonso, MD, PhD, coordinator of the COPD Working Group of the Spanish Society of Internal Medicine. Up to 73 comorbidities associated with chronic obstructive pulmonary disease have been described. Alonso made these remarks during her presentation at the Comorbidities in Chronic Obstructive Pulmonary Disease Panel, which took place during the 43rd Conference of the Spanish Society of Internal Medicine (SEMI), in Gijón, Spain. According to the scientific society's press release, moderator María Gómez Antúnez, MD, stated, "The correct approach and treatment of these comorbidities is fundamental to improve the quality of life of the patient, decrease exacerbations, avoid readmissions, and decrease morbimortality in people with chronic obstructive pulmonary disease." The different works published, two of them by the SEMI COPD Working Group (ECCO and ESMI studies), indicate that the main comorbidities of patients with that pneumopathy are arterial hypertension, dyslipidemia, diabetes, heart failure, atrial fibrillation, ischemic heart disease, chronic kidney disease, peripheral arterial disease, and osteoporosis. Chronic hepatopathy, pulmonary neoplasm, depression, and cerebrovascular disease are less common.

Masimo and Philips Expand Partnership to Improve Telehealth

January 18 2023

Masimo and Royal Philips announced an expansion of their partnership to augment patient monitoring capabilities in home telehealth applications with the Masimo W1 advanced health tracking watch. The W1 will integrate with Philips’s enterprise patient monitoring ecosystem to advance the forefront of telemonitoring and telehealth. The combined innovation, which draws upon the two global medical technology leaders’ extensive expertise in monitoring, connectivity, and automation, will be highlighted later this month at Arab Health 2023. Masimo W1 is the first watch to offer accurate, continuous pulse oximetry measurements and other insightful health data. Using Masimo’s secure health data cloud, patient information will be relayed to the Philips patient monitoring ecosystem for remote clinician surveillance. Hospital clinicians will be able to seamlessly and remotely monitor key health markers as their patients move throughout their homes and go about their daily lives. Physicians will be able to more confidently discharge patients knowing that their vital signs will still be monitored (via Masimo W1) and their physiological status tracked (via Philips dashboards), helping them catch possible patient deterioration sooner and make more informed interventions. This breakthrough combination of monitoring and connectivity technologies will enable numerous opportunities supporting early discharge initiatives, hospital-at-home programs, and chronic illness management. Bilal Muhsin, Chief Operating Officer of Masimo Healthcare, said, “Expanding our partnership with Philips in this way is a win-win for patients and clinicians everywhere, and is an important part of our multi-year plan to bring the best of hospital monitoring to the home while continuing to improve access to quality hospital care.” “At Philips, we believe in an open ecosystem of information that enables physicians in their daily routine, allows for them to access and process vital patient information and deploy a wide range of measurements and patient-worn technologies,” added Christoph Pedain, General Manager, Hospital Patient Monitoring at Philips. “Our integration of the latest Masimo technologies is a testament to that strategy and we are delighted to deepen our relationship with Masimo.” Masimo W1 for use in medical applications is CE marked and is pending FDA clearance.

Obesity Impacts Peripheral Airway Reactivity, Asthma

January 16 2023

Peripheral airway response to methacholine was similar among obese adults with and without asthma, although forced expiratory volume was lower for those with asthma, based on data from 53 individuals. Obesity remains a risk factor for asthma, and obese individuals with asthma tend to have worse control and more severe disease compared to nonobese asthma patients, wrote Anne E. Dixon, MD, BM, BCh, of the University of Vermont, Burlington, and colleagues.

Previous studies have shown that airway reactivity can occur in obese individuals without airway inflammation, but studies characterizing obese asthma based on lung function are lacking, they said. "Combining spirometry and oscillometry might reveal abnormalities in lung mechanics particularly pertinent to people with obesity and asthma," the researchers noted. In a cross-sectional study published in the journal Chest, the researchers reviewed data from 31 obese adults with asthma and 22 obese adults without asthma. The participants were aged 18 years and older, with forced expiratory volume (FEV1) of at least 60% of predicted. All had class III obesity, with an average BMI of 47.2 kg/m2 for those with asthma and 46.7 kg/m2 for nonasthma controls. Demographic characteristics were similar between the groups. Airway reactivity was defined as a 20% decrease in FEV1 and/or a 50% change in resistance or reactance at 5 Hz (R5 and X5), at a concentration of 16 mg/mL or less of methacholine. Patients were assessed using spirometry and oscillometry. Overall, most obese individuals with and without asthma showed significant changes in peripheral airway resistance. For those with asthma, the resistance at 5 Hz, measured by oscillometry, increased by 52% in response to the PC20 methacholine challenge, with an area under the reactance curve (AX) of 361%. For controls without asthma, the resistance at 5 Hz increased by 45%, with an AX of 268% in response to 16 mg/mL of methacholine.

This finding suggests that obesity predisposes individuals to peripheral airway reactivity regardless of asthma status, the researchers wrote in their discussion.

Comorbidities and the Prognosis of Chronic Obstructive Pulmonary Disease

January 16 2023

Strict control of comorbidities in patients with chronic obstructive pulmonary disease decreases exacerbations, morbimortality, and avoids readmissions. An increasing number of women have the disease, which progresses differently in women than in men and even has different comorbidities. "Comorbidities in patients with chronic obstructive pulmonary disease are more common in older adults, in those with more advanced pulmonary disease, and in those that are hospitalized for an acute exacerbation," said Belén Alonso, MD, PhD, coordinator of the COPD Working Group of the Spanish Society of Internal Medicine. Up to 73 comorbidities associated with chronic obstructive pulmonary disease have been described. Alonso made these remarks during her presentation at the Comorbidities in Chronic Obstructive Pulmonary Disease Panel, which took place during the 43rd Conference of the Spanish Society of Internal Medicine (SEMI), in Gijón, Spain. According to the scientific society's press release, moderator María Gómez Antúnez, MD, stated, "The correct approach and treatment of these comorbidities is fundamental to improve the quality of life of the patient, decrease exacerbations, avoid readmissions, and decrease morbimortality in people with chronic obstructive pulmonary disease." The different works published, two of them by the SEMI COPD Working Group (ECCO and ESMI studies), indicate that the main comorbidities of patients with that pneumopathy are arterial hypertension, dyslipidemia, diabetes, heart failure, atrial fibrillation, ischemic heart disease, chronic kidney disease, peripheral arterial disease, and osteoporosis. Chronic hepatopathy, pulmonary neoplasm, depression, and cerebrovascular disease are less common.

First and Only Asthma Rescue Medication Approved in the US

January 12 2023

AIRSUPRA (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The approval by the Food and Drug Administration (FDA) was based on results from the MANDALA and DENALI Phase III trials. In MANDALA, AIRSUPRA significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. Importantly, in the secondary endpoint of mean annualized total systemic corticosteroid exposure, AIRSUPRA demonstrated a significant reduction compared to albuterol at the approved dose of 180mcg albuterol/160mcg budesonide. In DENALI, AIRSUPRA significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma. AIRSUPRA is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the US. It is being developed by AstraZeneca and Avillion. Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of AIRSUPRA means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “With patients experiencing more than 10 million asthma exacerbations each year in the US and uncontrolled asthma expected to cost the US economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the US. Physicians will be able to offer their patients AIRSUPRA, an important new rescue treatment that reduces the risk of asthma exacerbations.” Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide. In the US over 21 million adults have asthma, representing more than 80% of the total number of people with asthma. Adults have 8.5 million exacerbations each year in the US. Uncontrolled asthma will cost the US economy an estimated $300 billion (in 2018 dollar values) in the next 20 years in direct medical costs alone. The safety and tolerability of AIRSUPRA in both trials were consistent with the known profiles of the components, with the most common adverse events including headache, oral candidiasis, cough and dysphonia.Results from the MANDALA trial were published in the New England Journal of Medicine in May 2022.

Financing Founds for Respiratory Care

January 11 2023

Honeywell and Telesair, Inc., an innovator of next generation respiratory care, jointly announced that Telesair, Inc. has closed a total of $22 million Series A round financing led by Pasaca Capital with participation from existing and new investors such as ZhenCheng Capital, Shangbay Capital, Device of Tomorrow Capital, Berkeley Catalyst Fund and Ultrastar Ventures LLC. The round of funding will support the commercialization of Telesair's Bonhawa Respiratory Humidifier, a unique, differentiated respiratory solution for use in the ICU and the development of a second-generation, revolutionary product designed to get patients out of the hospital sooner and safely at home longer. “We are excited to be moving into the next step of our evolution as a company," said Telesair CEO, Bryan Liu. "This funding helps us further advance our mission and fully launch our first generation Bonhawa platform technology as we continue to develop second generation innovations to address a multi-billion-dollar market that is underserved today. In an age of dramatically increasing respiratory disease challenges, simple-to-use medical respirators are paramount to treatment and empower patients to experience a better quality of life. We're delighted that our funding partners share our vision and have confidence in our ability to deliver real solutions to a major global need." "Telesair, Inc.’s innovative products, strong team and execution capability fit perfectly to our investment philosophy," said Charles Huang, Founder and Chairman of Pasaca Capital. "We are proud to support Telesair and be a part of its growth. We look forward to supporting Telesair through forthcoming development and commercialization milestones, and we are excited to see the company's progress in the months and years ahead." Honeywell Ventures is the venture arm of Honeywell that invests in early-stage, high-growth companies that have emerging and disruptive technologies which will change how we live, work and use energy. "Honeywell is aligned with Telesair's mission to improve lives through innovation in digital healthcare" said Patrick Hogan, Managing Director of Honeywell Ventures. "We are impressed with their mission and technology roadmap, and we are excited to collaborate with them in critical areas such as advanced sensing and remote patient monitoring, enabled by artificial intelligence and machine learning."

VERO Biotech Receives FDA Approval of its Third Generation Tankless Inhaled Nitric Oxide Delivery System

January 9 2023

VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of the newest generation of its tankless inhaled nitric oxide (iNO) delivery system.

GENOSYL DS is a tankless and portable system engineered with redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients with an easy-to-use interface and portability features. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden.

The Third Generation GENOSYL® Delivery System – developed for respiratory therapists by respiratory therapists – has new features that are expected to deliver three key benefits for patients, clinicians and providers.

These include:

Faster dosing, enabled by an adaptive sensor and automated cassette activation that accelerate time to achieve the desired dose.

Simpler workflow, as clinicians can now work from one console. The new delivery system has a dual cassette bay within each console, and transitions cassettes automatically. Previously, with a single cassette, clinicians needed to transition to a second console.

Operational efficiency, facilitated by an improved user interface and smaller, lighter disposable cassettes that alleviate storage constraints within hospitals.

"The enhancements to the GENOSYL Delivery System Console will help me to work more efficiently," said Denise Lauderbaugh, MPH, BSRC, RRT-NPS and Clinical Practice Specialist, Rady Children's Hospital, San Diego, CA. "It has two cassettes in one console, and they are even smaller than before; it automatically activates and transitions to the second cassette when the first one is depleted; and I no longer have to transition from a primary to a standby console. I can care for my patients through the operation of just one console," she added.

"The continuous innovation of the GENOSYL Delivery System represents our commitment to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face," said Brent V. Furse, CEO and President, VERO Biotech. "We are grateful for the partnership and support we received with the launch of our innovative tankless GENOSYL Delivery System and this collaboration that has and will allow VERO Biotech to continue to expand on its mission to save lives, alleviate suffering and improve the health economics of acute care."

GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA). Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension. Unlike tank-based systems, GENOSYL DS generates iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks and helps to simplify clinical workflow.

GENOSYL (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Important Safety Information

  • GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
  • Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
  • Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.
  • Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
  • In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
  • The most common adverse reaction is hypotension.
  • Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
  • GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.

Visit for the full Prescribing Information for GENOSYL.

Company Rakes in Awards

January 6 2023

Werfen announced that it has received five 2022 IMV ServiceTrak Awards including Best System Performance and Best Service in the Coagulation (Hemostasis) category, as well as Best Customer Satisfaction, Best System Performance and Best Service in the Blood Gas category. These honors mark the fourth-consecutive year Werfen has been recognized in Coagulation since this category was established in 2018, and the second time Werfen has swept Blood Gas, since the category was established in 2020. IMV ServiceTrak 2022 Clinical Laboratory Awards are presented to manufacturers whose customers are highly satisfied with their products and services. Results are based on interviews conducted with respondents in 1,716 clinical testing locations in the US, representing 2,169 instruments. As the leading market research and business intelligence provider to the laboratory diagnostic industry, IMV has been a laboratory benchmarking standard for over 25 years. “It’s an incredible honor to have the quality of our products and customer service, in both our Hemostasis and Acute Care Diagnostics business lines, recognized among the winners of the 2022 IMV awards,” said Bill Crandell, Vice President of Commercial Operations, North America at Werfen. “This is a testament to the hard-work and commitment of the entire Werfen team, from those who develop and manufacture the very best products, to those who provide the very best support at our customers’ sites. Their efforts enable us to fulfill our Purpose: to Power Patient Care.” The Werfen Hemostasis Diagnostics Management product portfolio is comprised of in vitro diagnostics systems, reagents and information technology solutions used to diagnose and guide treatment of thrombotic and bleeding disorders. ACL TOP Family 50 Series Hemostasis Testing Systems for routine and specialty testing, offers unprecedented pre- analytical quality assurance, risk-management, and laboratory accreditation benefits. The ACL AcuStar is the first specialty testing analyzer to offer full automation of highly sensitive immunoassays, with no special training required. HemoCellTM Specialized Lab Automation, a unique Hemostasis workcell, allows Hemostasis labs to standardize their testing processes, while HemoHubTM Intelligent Data Manager centralizes oversight and access to Werfen testing systems for operational performance, quality management and clinical-decision support. The comprehensive and fully automated HemosI assay portfolio, including routine and specialty testing, is designed for disease state management.

New Study Finds That Masimo Patient SafetyNet Helped Clinicians Reduce CPR Events and Rates

January 5 2023

Masimo announced the findings of a before-and-after study published in PLoS ONE in which Dr Ahmed Balshi and colleagues at King Saud Medical City in Riyadh, Saudi Arabia, evaluated the impact of implementing remote patient monitoring with Masimo Patient SafetyNet on the efficacy of hospital rapid response teams (RRTs). Comparing outcomes before and after implementation of Patient SafetyNet, they found that the “after” group experienced more RRT activations but had significantly lower incidence and rate of cardiopulmonary resuscitation (CPR), significantly shorter hospital length of stay (LOS), and lower hospital mortality. Noting that RRT activation depends on the “timely detection of [patient] deterioration,” the researchers sought to determine whether a remote patient surveillance system that automated calculation and relaying of early warning scores could lead to earlier recognition of changes in patient status and the improved efficacy of RRTs. They hypothesized that implementing such a system could decrease the rate of severe adverse events, as a result of potentially quicker RRT activation. To that end, they designed a “before” and “after” study at a large government hospital (1,200 inpatient beds) in central Saudi Arabia where the ICU provides outreach, in the form of an RRT, to the general ward. In the “before” period (retrospective data) nurses manually recorded patient vital signs, calculated warning scores, and activated RRTs; in the “after” period” (prospective data), vital signs data collected at the bedside, alongside automatically calculated warning scores, were wirelessly relayed to nursing stations for centralized remote patient surveillance and RRT activation. Both before and after, activation of an RRT was triggered when a patient’s vital signs deteriorated to the point they scored ≥ 5 on the MEWS (Modified Early Warning Score) scale. “Before” group data was analyzed from 2,346 adult patients from January to August 2020, and “after” group data from 2,151 patients from September 2020 to April 2021. For the “after” group, Masimo Patient SafetyNet was used to automate transfer of bedside monitoring data to central nursing stations, with alarm and notification data also relayed to clinicians’ smartphones using Masimo Replica. The researchers found that in the “before” group, there were 78 episodes of CPR over 20,510 total inpatient days, for an incidence of 3.3% and rate of 3.8 per 1000 inpatient days (95% confidence interval: 3 – 4.7 episodes). In the “after” group, there were 42 episodes over 17,945 inpatient days, for an incidence of 1.95% and rate of 2.3 per 1000 inpatient days (95% CI: 1.7 – 3.2). CPR incidence in the “after” group was significantly lower (p = 0.01). In addition, the CPR success rate was significantly higher in the “after” group (before: 38.5% vs. after: 59.5%; p = 0.04). The average hospital LOS was higher in the “before” group (before: 8.7 days ± 3.4 days vs. after: 8.3 days ± 3 days; 95% CI of the difference: 0.2 – 0.6 days; p < 0.001). The number of RRT activations was lower in the “before” group (before: 20 ± 7 vs. after: 23.7 ± 9.4; 95% CI of the difference: 3.2 – 4.2; p < 0.001). Overall hospital mortality was lower in the “after” group (before: 5.45% vs. after: 4%; 95% CI: 0.6 – 2.2; p < 0.001). Using multivariable logistic regression, they calculated that being in the “after” group decreased a patient’s odds of needing CPR by 33% (odds ratio: 0.67; 95% CI: 0.46 – 0.99; p = 0.04). The investigators concluded, “Automated activation of the RRT by Masimo Patient SafetyNet applied to medical ward patients significantly reduced CPR events and rates, reduced hospital length of stay, and increased the number of RRT activations. There was no difference in the ICU admission rates. Further evaluation of the system in surgical wards and mixed settings [should be] conducted.”

CAIRE Completes Acquisition of MGC Diagnostics

JANUARY 4 2023

CAIRE Inc., the leading global manufacturer of oxygen therapy and on-site generation systems, has finalized the acquisition of St. Paul, Minnesota-based MGC Diagnostics Holdings, Inc. (MGC). This acquisition strengthens CAIRE’s position and focus on diagnostic technologies — furthering expanding its expertise in serving patients throughout the progression of pulmonary disease. Through this expansion of its time-proven portfolio of personal portable and stationary oxygen therapy solutions, and larger onsite generation solutions, CAIRE adds MGC’s well-respected brand of non-invasive cardiorespiratory diagnostic systems, accessories, and consumables for the detection, classification, and management of cardiorespiratory disease. “This acquisition provides the means of serving the patient in a more holistic way — improving their quality of care throughout their entire journey. With MGC, we address the needs of patients early in the progression of pulmonary disease with a proven portfolio of equipment that addresses awareness and diagnostic tools for the healthcare provider and clinician. After diagnosis, CAIRE’s oxygen therapy portfolio, which covers the entire continuum of care, can be leveraged to manage the patient’s disease and ensure the best possible quality of life. This is a win for CAIRE, but most importantly the patient, and quality respiratory care everywhere.” said Earl Lawson, CAIRE President and CEO. “We also expect to leverage CAIRE’s well-established global distribution and manufacturing footprint to expand patient access to this expanded set of solutions.” Established in 1977, MGC is the number two player globally in the cardiorespiratory diagnostics sector. In addition to its St. Paul headquarters, MGC has facilities in Belgium, Germany, France, and Australia with more than two hundred employees. The company has a broad portfolio of products anchored by its pulmonary function testing systems, cardiopulmonary exercise systems, spirometers, flow sensors, gas analyzers, and associated consumables. An aging population contributes to continued growth in prevalent populations for conditions requiring cardiorespiratory diagnostic testing. More than 65 million patients suffer from COPD, the third leading cause of death worldwide, and more than 300 million patients suffer from asthma globally. Both these populations continue to grow annually and are responsible for more than $100 billion annually in healthcare spending. “The MGC team is excited about CAIRE’s acquisition of MGC. The additional resources that CAIRE and its parent NGK SPARK PLUG CO., LTD offer will enable the MGC business to accelerate its plans for expansion and growth to better serve respiratory patients around the globe. These plans include continued strengthening of the product portfolio and improved access in current and new markets,” said Todd Austin, MGC CEO. Acquired by NGK SPARK PLUG in 2018, CAIRE is poised for continued growth as the organization further expands its portfolio of solutions to serve the greater medical and healthcare markets, a part of its overall diversification outside of its core internal combustion engine business. Brookwood Associates acted as the financial advisor to CAIRE in this acquisition.

High Dupilumab Discontinuation in Small Nasal Polyposis Case Series

DECEMBER 30 2022

Almost 1 in 4 patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) that was treated with dupilumab discontinued taking the drug because of adverse events (AEs), according to a recent case series. The research, published November 17 in International Forum of Allergy and Rhinology, is the first case series to highlight potential risks of dupilumab treatment for CRSwNP. "Of the 58 total patients undergoing treatment with dupilumab for more than 6 months in the tertiary care clinic, 14 patients (24.1%) experienced AEs that required discontinuation of dupilumab," write lead study author Daniel J. Lee, MD, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues. "The leading causes were dermatologic with skin rashes or pruritus and musculoskeletal with severe joint pain." To investigate dupilumab's real-world safety profile, Lee and his research team conducted a retrospective chart review of patients with CRSwNP who had received subcutaneous injections of dupilumab 2 mL (300 mg) every 2 weeks between November 2018 and February 2022 at one academic rhinology and allergy clinic. The average age of the participants in both outcome groups was around 50 years. The groups were well balanced with respect to gender, as well as smoking and alcohol use, history of autoimmune disease, diabetes, hypertension, asthma, atopic dermatitis, and prior sinus surgery. All participants had undergone prior sinus surgery and had been taking dupilumab for CRSwNP with or without asthma treatment for an average of 7.3 months. Participants who stopped taking dupilumab did so within a median of 4 months of starting treatment; 42.9% (6 of 14) cited severe rash as the main reason for discontinuation, and 35.7% (5 of 14) cited severe joint pain. One person developed a drug-induced systemic lupus erythematosus–like reaction with positive antinuclear antibodies, and another developed angioedema that required medical care.

FLAMA/LABA Combos Tied to Varying Adverse Events in COPD

DECEMBER 30 2022

The risk for severe adverse events for patients with chronic obstructive pulmonary disease was significantly lower among those treated with glycopyrronium/indacaterol or umeclidinium/vilanterol compared with those treated with tiotropium/olodaterol, based on data from nearly 45,000 individuals. Fixed-dose combinations (FDCs) of long-acting muscarinic antagonists (LAMAs) and long-acting beta-agonists (LABAs) remain the foundation of treatment for chronic obstructive pulmonary disease (COPD), but concerns persist about potentially increased risk for cardiovascular events, especially among new users, wrote Ching-Fu Weng, MD, PhD, of Hsinchu Cathay General Hospital, Hsinchu, Taiwan, and colleagues. Data comparing the incidence of severe adverse events among different LAMA/LABA combinations are lacking, they said. In a study published in the journal Chest, the researchers reviewed claims data from the National Health Insurance Research Database and mortality data from the National Death Registry, both in Taiwan, from 2010-2019. The study population included 44,498 patients with COPD aged 40 years and older who were new users of any of three available FDCs between January 2015, and June 2019. Patients with concomitant LAMA and LABA in their previous 12 months were excluded. The FDCs were glycopyrronium/indacaterol (GLY/IND), umeclidinium/vilanterol (UMEC/VI), and tiotropium/olodaterol (TIO/OLO). GLY/IND was prescribed to 15,586 patients, 20,460 patients got UMEC/VI, and 8452 patients received TIO/OLO. Baseline characteristics were similar among the treatment groups. The primary outcome of severe adverse events was defined as hospitalization or an emergency department visit with a primary diagnosis of COPD or a secondary diagnosis of a severe AE; the secondary outcome was one of several cardiovascular events including acute myocardial infarction, heart failure, or arrhythmia. The median follow-up period was 6 months for the UMEC/VI and GLY/IND groups, and 60 days for the TIO/OLO group. During the follow-up period, the incidence of severe AEs was lower in the UMEC/VI group compared with the TIO/OLO group (17.85 vs 29.32 per 100 person-years, hazard ratio [HR], 0.76). Similarly, the incidence of severe AEs was lower in the GLY/IND group compared with the TIO/OLO group (15.54 vs 25.53 per 100 person-years, HR, 0.77). The incidence and risk for any severe AEs was similar between the UMEC/IV and GLY/IND groups. In a sensitivity analysis, the between-group differences decreased when both severe and moderate AEs were included or in an intent-to-treat analysis, the researchers noted. However, effectiveness remained similar for the UMEC/VI and GLY/IND groups, they said. For the secondary outcome of cardiovascular events, patients in the GLY/IND group had a significantly lower rate compared with the TIO/OLO group (2.49 vs. 4.28 per 100 person-years, HR 0.70), but this difference vanished when the follow-up was 6 months or less. No significant differences appeared in cardiovascular events between the UMEC/VI and GLY/IND groups or between the UMEC/VI and TIO/OLO groups.

Fat-Free Mass Index Related to Outcomes in Underweight COPD Patients

DECEMBER 30 2022

Higher fat-free mass was tied to exercise outcomes in patients with chronic obstructive pulmonary disease who were underweight, but not in those who were obese or nearly obese, based on data from more than 2000 individuals. Change in body composition, including a lower fat-free mass index (FFMI), often occurs in patients with COPD irrespective of body weight, write Felipe V.C. Machado, MSc, of Maastricht University Medical Center, the Netherlands, and colleagues. However, the impact of changes in FFMI on outcomes including exercise capacity, health-related quality of life (HRQL), and systemic inflammation in patients with COPD stratified by BMI has not been well studied, they said. In a study published this month in the journal Chest, the researchers reviewed data from the COPD and Systemic Consequences – Comorbidities Network (COSYCONET) cohort. The study population included 2137 adults with COPD (mean age 65 years,; 61% men. Patients were divided into four groups based on weight: underweight (UW), normal weight (NW), pre-obese (PO), and obese (OB). These groups accounted for 12.3%, 31.3%, 39.6%, and 16.8%, respectively, of the study population. Exercise capacity was assessed using the 6-minute walk distance test (6MWD), health-related quality of life was assessed using the Saint George's Respiratory Questionnaire for COPD, and systemic inflammation was assessed using blood markers including white blood cells (WBC) count and C-reactive protein (CRP). Body composition was assessed using bioelectrical impedance analysis (BIA). Overall, the frequency of low FFMI decreased from lower to higher BMI groups, occurring in 81% of UW patients, 53% of NW patients, 42% of PO patients, and 39% of OB patients.

Philips Says Tests on Recalled Products Show Limited Health Risks

DECEMBER 30 2022

Dutch health technology company Philips (PHG.AS) said on Wednesday independent tests on its respiratory devices involved in a major global recall had shown limited health risks. The company rocked investors last year by recalling millions of breathing devices and ventilators used to treat sleep apnea, because foam used to dampen noise from the devices might degrade and become toxic, carrying potential cancer risks. "We can state that the whole product complies with safety norms. That is very encouraging news," Chief Executive Roy Jakobs said. Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was "unlikely to result in an appreciable harm to health in patients", provided the machines had not been treated with ozone-based cleansing products.

Device Earns Approval

DECEMBER 12 2022

React Health, a medical device manufacturer focused on Sleep and Respiratory Products, announced 510(k) clearance by the US Food and Drug Administration (FDA)for the Luna G3 Bilevel S/T 30Vt as a Non Invasive Ventilator (NIV). This expands the utilization of the device beyond the Sleep Disordered Breathing (SDB) space into management of chronic respiratory conditions. “We are pleased that the FDA has approved the expanded use of the Luna G3 Bilevel S/T 30Vt as a Non Invasive Ventilator” said Clint Geffert, React Health’s President of Commercial Operations. “React Health remains committed to the successful treatment of Chronic Sleep and Respiratory Diseases and this approval further strengthens our offerings to help improve the lives of millions of patients suffering from these conditions. The Luna G3 Bilevel S/T joins our growing portfolio of respiratory products and offers prescribers and providers options at a time when recalls and supply chain challenges have impacted market availability of devices.” said Geffert.

New Lung Treatment for Neonates


Beyond Air, Inc., a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, announced that the US Food and Drug Administration (FDA) has approved LungFit PH to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN) (prescription use only). LungFit PH is the initial device from the LungFit therapeutic platform of nitric oxide generators that use our patented Ionizer technology and is the first FDA-approved product for Beyond Air. Steve Lisi, Chairman and CEO of Beyond Air, commented, “The FDA approval of LungFit PH enables a new era of nitric oxide therapy and marks a pivotal event for Beyond Air as we officially enter the U.S. market. As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximize the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements.” Lisi added, “I am immensely proud of the Beyond Air team for navigating a multitude of obstacles over the past five years, especially the last 27 months during the global pandemic, to bring this revolutionary device to market. The approval of LungFit PH validates our patented Ionizer technology and lays out a premarket approval model for our other LungFit platform devices, including LungFit PRO and LungFit GO. We believe that LungFit PH is just the first in a series of our medical devices that, if approved, will become available for treating a wide variety of respiratory diseases as we remain dedicated to our mission of harnessing the power of nitric oxide for all who can benefit from this transformational therapy.” LungFit PH uses patented Ionizer technology to generate unlimited on-demand nitric oxide from ambient air and deliver it to a ventilator circuit, regardless of dose or flow. The device uses a compressor to drive room air through a plasma chamber where pulses of electrical discharge are created between two electrodes. The LungFit PH system uses power equivalent to a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, forming nitric oxide with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas is then passed through a Smart Filter, which removes the toxic NO2 from the internal circuit. For the treatment of PPHN, the novel LungFit PH system is designed to deliver a dosage of NO to the lungs that is consistent with the current standard of care for delivery of 20 ppm NO with a range of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients. Each Smart Filter will last 12 hours regardless of ventilator demands and replacing a filter takes just a few seconds. NO gas is a vasodilator approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. Low concentration inhaled NO therapy has been the standard-of-care for PPHN for over 20 years in the United States. PPHN is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4-6.8/1,000 live births) with a mortality rate ranging between 4-33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. The Beyond Air commercial team will be actively working with select hospitals beginning this month to make LungFit PH available to them with a broader US hospital launch expected in the first half of 2023.

Company Launches Full Market Release of Watch


Masimo announced the full market release of Hydration Index (Hi) for the Masimo W1 watch. The Masimo W1, an advanced health tracking wearable, is the first watch to offer accurate, continuous pulse oximetry measurements and insightful health data, from the leader in hospital pulse oximetry. Hydration Index, first announced earlier this year in a limited market release, provides an index that tracks an individual’s hydration levels and integrates seamlessly with other continuous Masimo W1 health data, such as oxygen saturation (SpO2), pulse rate, respiration, and more. Hydration level has been one of the most sought out parameters by athletes, vocalists, and others seeking to optimize their performance. Since creating PVi – which allows clinicians to assess fluid responsiveness of mechanically ventilated patients – nearly 15 years ago, Masimo has been working to invent a way to help people gain insight into hydration. Proper hydration is widely recognized as an important aspect of health and performance, and lack of proper hydration affects many physiological parameters, as the body works to restore homeostasis. Masimo W1 is designed to help you identify your hydration baseline, helping you understand your hydration level, which not only affects athletic performance, but can also support healthier lifestyle decisions. Whether you’re an elite athlete, a vocalist, a health-focused individual, or just keen to gain more insight into your body’s physiological status, Masimo W1 with Hydration Index represents a breakthrough solution to better understand and manage hydration health. Tommy Haas, Olympic silver medalist and professional tennis player, said, “I have wanted to know the level of my hydration since I began competing, but always had to guess about it. Masimo W1 with Hydration Index finally makes this possible.” Nick Mayhugh, World Record holder and three-time Paralympic champion, added, “As a professional athlete who trains six days a week and ten hours a day, I need to know my hydration levels at all times. Masimo’s Hydration Index technology will provide athletes of all levels the opportunity to maximize their training and recovery programs, leading to optimal performance.” Known for its exceptional accuracy and reliability during challenging conditions, such as motion and low perfusion, Masimo, with the Masimo W1, brings its expertise in signal processing, photonics, and bio-sensing to consumers looking to take control of their personal health, make better health decisions, and monitor their overall physiological status. Masimo W1 pairs via secure Bluetooth to the Masimo Health smartphone app to unlock meaningful, actionable insights. The integrated Personal SafetyNet subscription service gives users access to sophisticated reporting tools to help them review their physiological status over time and facilitates sharing data with family members, fitness trainers, wellness coaches, and where allowed, healthcare providers. Benefiting from Masimo’s expertise in hospital connectivity and hospital automation, a medical version of Masimo W1 will be available outside the US for use in telehealth and telemonitoring applications via Masimo SafetyNet and Personal SafetyNet for healthcare providers and payers, as well as individual use. Masimo W1 is a convenient, reliable remote monitoring and telehealth solution enabling hospitals and clinicians to proactively keep track of their patients’ physiological status from afar, even as patients go about everyday tasks at home. A natural complement to the Masimo SafetyNet remote patient monitoring platform, Masimo W1 enables wireless transmission of patient data to the Masimo SafetyNet app and Masimo’s secure data cloud, where it can be reviewed in near-real time by remote monitoring teams in centralized locations for signs of physiological decline or sudden changes, such as falls or spikes in heart rate. Dr Amin, Professor, Endowed Chair of Medicine and Executive Director of Hospital Medicine at the University of California, Irvine, said, “Evaluating intravascular volume status is a common problem in clinical care, particularly for post-op patients and those with complicated chronic conditions such as congestive heart failure (CHF). These patients often seek care in the emergency department (ED) for monitoring and treatment. Masimo W1 helps individuals understand their hydration level by tracking their Hydration index (Hi), and provides a common additional monitoring endpoint beyond daily weights for evaluation of hydration. Having continuous, noninvasive monitoring of Hi available in a wearable device means people are now able to access important, real-time information at home. This has the potential to be a game changer for all involved in the management of chronic conditions like CHF, and also for those managing post-op patients.” Joe Kiani, Founder and CEO of Masimo, said, “Masimo W1 represents numerous firsts: the first wrist-worn wearable device to offer consumers accurate, continuous pulse oximetry. The first—but not the last—such device from Masimo. And, with Hydration Index, the first watch to give users actionable, insightful hydration data, helping everyone to make healthier decisions so that they can live their best lives.” Masimo W1 and Hi have not been cleared by the FDA and are not available for use in medical applications in the US.

MediPines Expands Distribution of Technology to Canada

NOVEMBER 30 2022

Orange County, California based MediPines, a global market leader in the development of gas exchange measurements, has announced that its MediPines AGM100, the world’s first FDA-cleared, non-invasive pulmonary gas exchange analyzer, is now available throughout Canada, thanks to an agreement with LevoMed Canada Inc., a company focused on providing the Canadian health care market with high quality innovative products. This Canadian national distribution launch kicked off at the 50th meeting of the Respiratory Therapy Society of Ontario to help meet the growing demand for non-invasive assessments in the face of surging respiratory care. The MediPines AGM100 is the world’s only medical device which delivers a measure of a patient’s Oxygen Deficit (a non-invasive respiratory impairment severity measurement). The technology provides reliable, discriminative readings that enable real-time decision support for healthcare providers during times of surging respiratory patients and medical staff shortages. “As the exclusive Canadian distribution partner of MediPines, we are excited to bring the benefits of the AGM100 to the Canadian healthcare system,” said Madhu Venkat, LevoMed Canada’s CEO. “We’re enthusiastic about the partnership and are keen to support the growing need for effective, quick, and accurate gas exchange monitoring for the Canadian population with the help of the unique AGM100. It is an innovative cardiopulmonary diagnostic support technology, which we see as an important scientific innovation for detecting respiratory impairment non-invasively.” “It’s great to have a group of MedTech veterans such as Madhu, John, Mark, Perry, and William of the LevoMed team spearheading our technology adoption in leading hospitals throughout Canada, especially during this time of increased need,” said MediPines CEO, Steve Lee. Last year, the World Health Organization (WHO) designated the MediPines AGM100 as one of notable innovative health technologies for the treatment of COVID-19 and other global priority diseases in its WHO Compendium of Innovative Health Technologies.

Medical Masks, N95s May Offer Similar Prevention vs COVID: Study

NOVEMBER 30 2022

Regular medical masks might provide protection similar to that of N95 respirators in preventing SARS-CoV-2 infection among healthcare workers, according to the first randomized trial that tested the two types of masks head to head in the COVID-19 era. Owing to limitations in the study, however, the authors were only formally able to conclude that healthcare workers who wore medical masks while treating COVID-19 patients were not twice as likely to contract the virus as workers wearing N95 respirators. "Nonetheless, this trial provides the best evidence to date on comparative effectiveness of mask types in preventing SARS-CoV-2 infection in health care workers providing routine patient care," writes Roger Chou, MD, in an editorial published with the study. In summarizing, Chou said that "the results indicate that medical masks may be similar to N95 respirators in Omicron-era settings with high COVID-19" rates, but the researchers set a low bar for establishing whether one is more effective than the other. "Therefore, the results are not definitive," Chou writes. In the study, published in Annals of Internal Medicine, the authors evaluated 1009 healthcare workers in Canada, Israel, Pakistan, and Egypt who had not been vaccinated against SARS-CoV-2 and had not previously been infected by the virus. Participants were randomly assigned to wear either a medical mask or an N95 respirator for 10 consecutive weeks. The study period was from May 2020 to March 2022. Reverse transcriptase polymerase chain reaction tests confirmed that COVID occurred in 52 of 497 (10.46%) participants in the medical mask group, vs 47 of 507 (9.27%) in the N95 respirator group (hazard ratio [HR], 1.14; 95% CI, 0.77 – 1.69). The World Health Organization recommends medical masks (sometimes called surgical masks) for routine care, while the Centers for Disease Control and Prevention recommends that N95s be used while caring for COVID-19 patients. Prior to the pandemic, research showed that N95s and medical masks carried similar risks while caring for patients with influenzalike illnesses.

Persistent Asthma Linked to Higher Carotid Plaque Burden

NOVEMBER 30 2022

Persistent asthma is associated with increased carotid plaque burden and higher levels of inflammation, putting these patients at risk for atherosclerotic cardiovascular disease (ASCVD) events, new research suggests. Using data from the MESA study, investigators analyzed more than 5000 individuals, comparing carotid plaque and inflammatory markers in those with and without asthma. They found that carotid plaque was present in half of participants without asthma and half of those with intermittent asthma, but in close to 70% of participants with persistent asthma. Moreover, those with persistent asthma had higher interleukin-6 (IL-6) levels, compared with those without asthma or those with intermittent asthma. "The take-home message is that the current study, paired with prior studies, highlights that individuals with more significant forms of asthma may be at higher cardiovascular risk, and make it imperative to address modifiable risk factors among patients with asthma," lead author Matthew Tattersall, DO, MS, assistant professor of cardiovascular medicine, University of Wisconsin School of Medicine and Public Health, Madison, said.

Acquisition Being Finalized

NOVEMBER 29 2022

CAIRE Inc., a subsidiary of NGK SPARK PLUG CO., LTD., will acquire St. Paul, Minnesota-based MGC Diagnostics Holdings, Inc. (MGC). MGC designs, develops, manufactures, and markets non-invasive cardiorespiratory diagnostic systems, accessories, and consumables for the detection, classification, and management of cardiorespiratory disease. The acquisition will close by the end of the year. Established in 1977, MGC is the number two player globally in the cardiorespiratory diagnostics sector. In addition to its St. Paul headquarters, MGC has facilities in Belgium, Germany, France, and Australia with more than two hundred employees. The company has a broad portfolio of products anchored by its pulmonary function testing systems, cardiopulmonary exercise systems, spirometers, flow sensors, gas analyzers, and associated consumables. An aging population contributes to continued growth in prevalent populations for conditions requiring cardiorespiratory diagnostic testing. More than 65 million patients suffer from COPD, the third leading cause of death worldwide, and more than 300 million patients suffer from asthma globally. Both these populations continue to grow annually and are responsible for more than $100 billion annually in healthcare spending. The acquisition is a significant step in advancing CAIRE’s mission to connect with patients throughout the progression of pulmonary disease — including awareness, diagnosis, therapy, and monitoring. Following the acquisition of Spirosure (now CAIRE Diagnostics), a developer and manufacturer of a proprietary asthma diagnostic technology in 2020, the company will now have a global distribution channel directly into hospitals and clinics. “CAIRE is firmly committed to driving future growth by expanding our offerings in the clinical setting to better serve those individuals affected by cardiorespiratory diseases. MGC has a state-of-the-art portfolio that is widely adopted to diagnose respiratory disease and to ensure that the information obtained benefits disease management. These tools are an excellent complement to CAIRE’s complete range of oxygen therapy solutions,” said Earl Lawson, CAIRE President and CEO. “Furthermore, we are very excited to work with the talented MGC senior management team and global team of professionals who were responsible for the strategic planning and execution driving MGC’s strong growth. This will be key to a seamless integration of the business and the ongoing expansion in the marketplace.” “The MGC team is excited to become a part of the CAIRE organization. After outperforming the market consistently, we look forward to leveraging the resources of CAIRE and NGK SPARK PLUG to drive continued growth in our existing markets and to launch new products and technologies through our best-in-class distribution channels, “said Todd Austin, MGC CEO. The acquisition also supports the continued expansion of the Japan-based NGK SPARK PLUG portfolio of solutions to serve the greater medical and healthcare markets, as part of the overall diversification of its portfolio outside of its core internal combustion engine business.

New Study on Pulse Oximetry Accuracy

NOVEMBER 21 2022

Masimo announced the publication of a peer-reviewed study regarding Masimo SET pulse oximetry performance in varying skin pigmentation in the Journal of Clinical Monitoring and Computing. The retrospective trial, “Racial effects on Masimo pulse oximetry: a laboratory study,” by Drs Steven J. Barker and Wilson C. Wilson, found that there was no clinically significant difference in the accuracy or bias between Black and White subjects studied with Masimo SET pulse oximetry and Masimo RD SET sensors. For this newly published study Dr Barker (Chief Science Officer, Masimo) and Dr Wilson (Chief Medical Officer, Masimo) performed a retrospective analysis of Masimo laboratory data obtained from self-identified Black and White volunteer subjects, to evaluate differences in Masimo pulse oximeter accuracy and bias on the basis of skin tone. The investigators reviewed data collected between October 2015 and July 2021, which included 7,183 paired samples (3,201 Black and 3,982 White) collected from 75 subjects (39 Black and 36 White), who were screened with the same criteria to remove potential bias based on health conditions. All subjects were exposed to the same hypoxia protocol, which varied the arterial saturation of hemoglobin (SaO2) between 70% and 100%. Noninvasive oxygen saturation (SpO2) values were obtained from Masimo SET pulse oximeters with RD SET sensors and time-matched with simultaneously taken arterial blood gas (ABG) samples analyzed using an ABL-835 blood gas analyzer. The data were analyzed to determine the bias (mean difference in paired SpO2 and SaO2 samples), precision (standard deviation of the difference), and accuracy (root mean squared error, ARMS) for both groups. A negative bias of 0.20% was found for Black subjects, compared to 0.05% for White subjects. This difference of 0.15% (p < 0.001) is not clinically significant and the values are numerically indistinguishable because the SpO2 display resolution is 1% on commercially available pulse oximeters (both from Masimo and other manufacturers). The investigators also found a precision of 1.40% for Black subjects and 1.35% for White subjects. Accuracy (ARMS) was 1.42% for Black subjects and 1.35% for White subjects. These results are consistent with the accuracy specifications of RD SET sensors (1.5% accuracy ARMS), which are twice as good as the current FDA clearance thresholds for medical-grade pulse oximeters (3.0% accuracy ARMS). In discussing their findings, Drs. Barker and Wilson describe how Masimo SET accounts for skin pigmentation when measuring SpO2. “The absence of racial bias, and highly accurate overall performance exhibited by Masimo SET pulse oximetry can be logically explained by Masimo’s engineering design and testing paradigm. … Conventional pulse oximetry uses the standard red over infrared algorithm to provide SpO2, while Masimo SET uses that conventional algorithm along with four additional signal processing engines that all run in parallel. These signal processing systems allow the distinction between arterial and venous signal during motion and low perfusion by identifying and isolating the non-arterial and venous noise SpO2 from the true arterial SpO2 components in the signal. These multiple signal processing engines work together to overcome limitations of each independent method. This advanced technique allows for a more accurate picture of the pulsatile (arterial) signal and significantly reduces the impact of static absorbers such as skin pigment, bone density, and tissue thickness (e.g., finger, toe, or earlobe). Finally, the Masimo SET SpO2 algorithm is calibrated and then validated using nearly equal numbers of dark and light-skinned subjects.” Drs Barker and Wilson summarized, “In conclusion, this retrospective study of healthy human volunteers monitored with Masimo RD SET pulse oximeter sensors showed an absence of clinically significant differences in accuracy between Black and White subjects.” The authors suggested that additional prospective clinical studies should be conducted to validate their results in critically ill patients utilizing Masimo SET pulse oximeters and those from other manufacturers.

Sentec acquires Percussionaire

NOVEMBER 17 2022

Focused on advancing respiratory care, Sentec has acquired Percussionaire. Percussionaire was founded nearly 40 years ago by the late Dr Forrest Bird who was a pioneer in respiratory care. “For us, this acquisition is a unique opportunity to build on the legacy of Dr Bird and continue to invest in products that make a positive impact to patient care,” said Chairman of Sentec, AG, Dominik Ellenrieder, “In this new era, with COVID reminding us of the importance of respiratory monitoring and therapies, we believe the Percussionaire products have an important part to play to improve patient care by enabling the least invasive interventions.” With this acquisition, Sentec will diversify its product lines focused on respiratory monitoring to now include the Percussionaire range of products built on TRUE-IPV technology, increasing its ability to service and support respiratory care customers. Both Sentec and Percussionaire product lines play vital roles in the management of critical care patients; Bringing these products together provides the unique ability to simultaneously monitor and treat patients with varying levels of compromised respiratory function. Percussionaire is a specialty ventilation company that develops, manufactures, and markets products that are used in respiratory care. The company was formed nearly 40 years ago in Sandpoint, ID, still the home of its manufacturing and research and development facility, where Percussionaire continues to build on the legacy of its founder, Dr Forrest Bird. His breakthrough of Flow Ventilation and True-IPV technology is at the heart of Percussionaire, the only company offering these solutions across all patient types and clinical settings. Sentec is a market leader of non-invasive monitoring solutions who develops, manufactures, and markets patient-centric, cost-effective technologies and products that provide clinicians with greater insight to quickly to identify trends, rapidly and more accurately assess patient status, and make well-informed, timely care decisions that can improve patient care. Sentec is driven by the belief that noninvasive monitoring should enable the delivery of less invasive care. Sentec Headquarters is in Basel Switzerland.

RSV Causes 1 in 50 Deaths in Children Under Age 5: Study

NOVEMBER 15 2022

The respiratory illness RSV causes 1 in 50 deaths in children under age 5, mostly in low-income and middle-income countries, a new study says. But RSV – formally known as respiratory syncytial virus – is also a problem in high-income nations. In those countries, 1 in 56 otherwise healthy babies are hospitalized with RSV during their first year of life, said the study, which was published in The Lancet Respiratory Medicine. Researchers looked at the health records of 9,154 infants born between July 1, 2017, and July 31, 2020, who were treated at health centers across Europe. Previous studies have concentrated on babies with pre-existing conditions, but this one looked at otherwise healthy children, researchers said. “This is the lowest-risk baby who is being hospitalized for this, so really, numbers are really much higher than I think some people would have guessed,” said study co-author Louis Bont, MD, a professor of pediatric infectious diseases at Wilhelmina Children’s Hospital at University Medical Center Utrecht in the Netherlands. He is also chairman of the ReSViNET foundation, which aims to reduce RSV infection globally. The study said more than 97% of deaths from RSV occur in low-income and middle-income countries. The study concluded that “maternal vaccination and passive [immunization] could have a profound impact on the RSV burden.” In developed nations, children who get RSV usually survive because they have access to ventilators and other health care equipment. Still, just being treated for RSV can have long-range negative effects on a child’s health, Kristina Deeter, MD, chair of pediatrics at the University of Nevada, Reno, School of Medicine said.  “Whether that is just traumatic psychosocial, emotional issues after hospitalization or even having more vulnerable lungs – you can develop asthma later on, for instance, if you’ve had a really severe infection at a young age – it can damage your lungs permanently,” she said of the study. “It’s still an important virus in our world and something that we really focus on.” The Lancet study was published days after the CDC warned public health officials that respiratory viruses, including RSV, are surging among children across the country.

Spirometer Tested on Freedivers


ndd Medical Technologies (ndd), a global leader and innovator of diagnostic devices for the early detection of COPD and other chronic lung diseases, announces the successful deployment of its EasyOne Air portable spirometer for testing lung function at the world’s largest freediving competition, Vertical Blue. In a true test of the EasyOne Air’s capabilities in challenging field conditions, the benefits of the portable spirometer shone through, yielding accurate and consistent results in a sample of freedivers. Freediving is a form of underwater diving where participants plunge to depths as great as 100m, whilst holding their breath for periods of 3-4 minutes. The extreme nature of the sport puts freedivers at risk of lung barotrauma, pulmonary edema, and decompression sickness. The medical team at Vertical Blue wanted to ensure the safety of freedivers at the competition, and set about testing the participants’ lung function to find trends and establish ‘normal’ values in this extreme diving population. As part of a long-term initiative, the medical team also aimed to demonstrate that the activity can be safe, and to identify any associated risks. Thanks to the EasyOne Air’s unique ultrasonic flow measurement technology, highly accurate and consistent spirometry measurements were readily taken in the field, eliminating the need for cumbersome equipment associated with traditional spirometry methods. With instant results and no calibration or maintenance necessary, the team at Vertical blue were delighted with the device’s performance, as Jamie Juliano RN, CFRN and co-owner of Freedive Medicine LLC, commented: “Freediving presents unique challenges for our medical team: Freediving often operates in austere locations where medical equipment is sparce. The EasyOne Air helped us to research and evaluate pulmonary-related risks and proved to be an invaluable tool during the competition. Having ndd by our side will aid in continued evaluation of the unique pulmonary situations Freedivers face when participating in this sport.” EasyOne Air is designed to deliver accurate results immediately. With unique technology, premium precision components, and extensive quality control standards, high-quality spirometry results are always guaranteed.

Grifols receives FDA clearance


Grifols, a global leader in plasma-derived medicines and innovative diagnostic solutions, announced that its AlphaID At Home Genetic Health Risk Service, the first-ever free direct-to-consumer program in the U.S. to screen for genetic risk of alpha1-antitrypsin deficiency (alpha-1), has been cleared by the U.S. Food and Drug Administration (FDA). The service, also known as AlphaID At Home, is the company's first FDA clearance for direct-to-consumer use. It will be available beginning in Q2 2023 for U.S. adults to screen for their genetic risk level of developing lung and/or liver disease related to alpha-1 without a medical prescription. Alpha-1 is the most common risk factor for chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema and chronic bronchitis. It's estimated that around 16 million Americans have COPD, with millions more yet to be diagnosed. More than 90% of people with alpha-1 are believed to be undiagnosed. "Many COPD patients don't know their condition could be caused by alpha-1 because its symptoms are similar to those of COPD or asthma," said Scott Santarella, President & CEO of the Alpha-1 Foundation, pointing out that November is awareness month for both alpha-1 and COPD. "We wholeheartedly support initiatives and innovations that contribute to the diagnosis of alpha-1." To use the safe saliva collection kit, individuals simply collect their sample and send it to a certified lab for processing. Within a few weeks and through a secure online portal, they will know if they are at risk of developing alpha-1, a condition due to a lack of alpha1-antitrypsin (AAT). They are encouraged to share the results with their doctor and discuss potential treatment options. A user comprehension study for AlphaID At Home showed that a demographically diverse U.S. population of users (525 participants) could easily comprehend the service reports, with a 90% or greater rate of understanding. AlphaID At Home uses the same accurate test Grifols has made available to physicians globally since 2018 to screen for alpha-1, a focus on diagnosis that has led to more than 1 million patients being screened with Grifols technology over the last 20 years. The test can screen for the 14 most prevalently reported genetic mutations associated with alpha-1 – the most of any test of its kind – including the S, Z, F, I alleles, as well as rare and null alleles. "Grifols is very pleased that the FDA cleared the AlphaID At Home service, reflecting the robustness and accuracy of the testing platform as well as the value it will provide in helping people detect if they are at risk for alpha-1," said Antonio Martínez, President of Grifols Diagnostic. "As leaders in alpha-1 testing and treatment, Grifols is redoubling its commitment to the alpha-1 community." Only a physician or healthcare provider can make a diagnosis of alpha-1. To learn more about alpha-1, please visit the Alpha-1 Foundation at

FDA Clears New Laboratory Blood Glucose Reference Analyzer

OCTOBER 28 2022

The US Food and Drug Administration (FDA) has cleared Nova Primary as a blood glucose reference analyzer. Nova Primary fills the need for a new glucose reference analyzer to replace the discontinued YSI STAT PLUS 2300 Glucose and L-Lactate analyzer. Manufacturers of blood glucose measuring devices and clinical diabetes researchers have relied on the YSI 2300 as a reference and correlation analyzer. However, YSI, Inc. no longer supports the analyzer, and its discontinuation has left a critical industry void. The Nova Primary analyzer fills that need. With today’s FDA clearance, Nova Primary is now available in the US and worldwide. According to Matthew McRae, Nova Sales Product Line Manager, “We at Nova Biomedical are pleased to offer the Nova Primary, an accurate, easy-to-use and modernized blood glucose reference analyzer for glucose device manufacturers and clinical diabetes researchers to replace the discontinued YSI Stat Plus glucose analyzer.” Like the YSI 2300, Nova Primary uses a single, reusable glucose electrochemical sensor based on glucose oxidase and has a measurement range of 20-900 mg/dL. It uses a small, 25 microliter venous whole blood or plasma sample which is internally diluted as in the YSI. Results are available in approximately 2 minutes. Nova Primary’s large color touchscreen display and intuitive, icon-based graphical user interface make it very straightforward to use. A single calibrator pack uses RFID data management to monitor the pack expiration date and number of samples remaining, eliminating the need for separate reagent bottles and daily monitoring of their levels. In clinical laboratory studies using venous whole blood and plasma, the Nova Primary demonstrated excellent correlation to the YSI 2300 and is traceable to NIST glucose standards. The Nova Primary uses a comma delimited (.csv) format data output that can be downloaded via the integral USB data port. The analyzer measures 17 in x 11 in x 18 in (44 cm x 28 cm x 46 cm).

Children and COVID: Weekly Cases Fall to Lowest Level in Over a Year

OCTOBER 28 2022

With the third autumn of the COVID era now upon us, the discussion has turned again to a possible influenza/COVID twindemic, as well as the new-for-2022 influenza/COVID/respiratory syncytial virus tripledemic. It appears, however, that COVID may have missed the memo. For the sixth time in the last 7 weeks, the number of new COVID cases in children fell, with just under 23,000 reported during the week of Oct. 14-20, according to the American Academy of Pediatrics and the Children’s Hospital Association. That is the lowest weekly count so far this year, and the lowest since early July of 2021, just as the Delta surge was starting. New pediatric cases had dipped to 8,500, the lowest for any week during the pandemic, a couple of weeks before that, the AAP/CHA data show. Weekly cases have fallen by almost 75% since over 90,000 were reported for the week of Aug. 26 to Sept. 1, even as children have returned to school and vaccine uptake remains slow in the youngest age groups. Rates of emergency department visits with diagnosed COVID also have continued to drop, as have new admissions, and both are nearing their 2021 lows, according to the Centers for Disease Control and Prevention. New vaccinations in children under age 5 years were up slightly for the most recent week (Oct. 13-19), but total uptake for that age group is only 7.1% for an initial dose and 2.9% for full vaccination. Among children aged 5-11 years, 38.7% have received at least one dose and 31.6% have completed the primary series, with corresponding figures of 71.2% and 60.9% for those aged 12-17, the CDC said on its COVID Data Tracker. Despite the low overall numbers, though, the youngest children are, in one respect, punching above their weight when it comes to vaccinations. In the 2 weeks from Oct. 6 to Oct. 19, children under 5 years of age, who represent 5.9% of the U.S. population, received 9.2% of the initial vaccine doses administered. Children aged 5-11 years, who represent 8.7% of the total population, got just 4.2% of all first doses over those same 2 weeks, while 12- to 17-year-olds, who make up 7.6% of the population, got 3.4% of the vaccine doses, the CDC reported.

What the RSV Surge Means for Doctors and Patients

OCTOBER 28 2022

In early October, respiratory syncytial virus, or RSV, tore through Victoria Thiele's Indiana home. Her three older children had manageable symptoms. But her 8-week-old newborn ended up developing a severe case. Thiele, whose family lives in Fort Wayne, said the baby experienced chest retractions while breathing and was taken to the emergency room at a local hospital, where she was diagnosed with RSV and bacterial pneumonia. Thiel's experience mirrors what's happening across the country. On Oct. 21, the CDC director tweeted that respiratory viruses, including the flu and RSV, are surging. Data from the CDC shows the percentage of those testing positive for RSV has more than doubled over the past month – straining the capacity of children's' hospitals as they try to care for the sickest patients. “Nobody has enough beds,” says Renee Higgerson, MD, pediatric intensivist and medical director at Pediatrix Critical Care of Texas and St. David's Children's Hospital. “We're taking care of patients in every possible location we can in the hospital.” Yvonne Giunta, MD, director of pediatric emergency medicine at Staten Island University Hospital, part of Northwell Health in New York, said the pediatric emergency department at her facility is seeing a high volume of RSV cases, along with other respiratory infections. “It's not uncommon for a surge in pediatric volume in the late fall and early winter,” Giunta says. “But this surge seems to have started earlier than in previous years.” RSV usually has a predictable seasonal pattern, peaking in late December to mid-February, according to the CDC. The virus hits young children hardest, causing about 58,000 hospitalizations of kids under the age of 5, and 100 to 300 deaths per year in that age group. But as the CDC noted, RSV was almost nonexistent in 2020, when pandemic prevention methods nearly knocked the virus out of circulation. Christopher J. Harrison MD, professor of pediatrics at the University of Missouri-Kansas City, said children get RSV by the time they are 2, and these first exposures make children less susceptible to the virus. But the COVID pandemic means that some children born over the past couple of years were never exposed to RSV. “Since the hiatus where we lost regular viruses, we ended up really shaking up the whole epidemiology thing,” Harrison says. The loosening of pandemic control measures coupled with a much more susceptible younger population is a “perfect storm” for this outbreak, he notes.

Large Trial of Home-Based COPD Rehab Shows Positive Results

OCTOBER 28 2022

The first multicenter randomized controlled trial of a home-based rehabilitation program for patients with chronic obstructive pulmonary disease (COPD) showed highly positive results, according to findings presented at the CHEST 2022 annual meeting. At the end of 12 weeks, those randomly assigned to the intervention had a significant and clinically meaningful improvement in all domains of the Chronic Respiratory Questionnaire (CRQ), including activity levels and emotional well-being, reported Roberto P. Benzo, MD, a consultant in the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota. Presenting soon-to-be-published data, Benzo said that the intervention is based on a tablet-based app. On the tablet, the patient finds a daily schedule of exercises and videos to guide performance. The tablet is programmed to upload data captured from an activity monitor and pulse oximeter. Along with documentation of app usage, the remote coach can then download this information to review with the patient. The primary outcome of the randomized study were the physical and emotional domains of the CRQ quality of life, but a long list of secondary outcomes — including physical activity, symptoms of depression, sleep quality, and healthcare utilization, such as emergency room visits — was also analyzed. In addition to the significant benefit on the primary outcomes, the home-based rehabilitation program relative to a wait list for intervention was associated with benefit or a trend for benefit on essentially every outcome measured. Healthcare utilization was a possible exception, but even then, the absolute number of visits was lower in the treatment arm. "With a study period of only 12 weeks, we were limited to our ability to show a difference in emergency room visits," said Benzo, who also noted that the study was conducted during the COVID-19 pandemic, when hospital visits were already occurring at a lower than usual rate. Based on the other findings, he suspects that a reduction in healthcare utilization could also be shown in more typical circumstances, particularly with a longer follow-up. In the study, 375 patients with COPD were randomly assigned to a home healthcare regimen delivered by an app with remote coaching or to a wait list and usual care. The median age was 69 years. Fifty-nine percent were women. The median FEV1 at enrollment was 45% of predicted. The patients were able to access their own data to monitor their progress at any time, not just at the time of coaching, but contact with the remote coach occurred on a weekly basis. Patients rated their level of energy, how they felt generally, and their progress toward daily goals, which was also captured on the app and could be discussed with the coach during the review of the previous week’s activity. At 12 weeks, the favorable 0.54-point change (P < .001) and 0.51 change (P < .001) in the physical and emotional summary scores, respectively, met the criteria for a clinically meaningful change, Benzo reported. There were also significantly favorable changes from baseline and relative to controls in CRQ domains of self-management, sleep quality, and depression (all P ≤ .01).

Aerodigestive and Airway Reconstruction Center First to Receive New State Designation

OCTOBER 7 2022

The Aerodigestive and Airway Reconstruction Center at Stanford Medicine Children’s Health has been named the first California Children’s Services (CCS) Aerodigestive Special Care Center (SCC) in the state. This designation requires programs to meet specific standards, including offering a highly specialized multidisciplinary care team and clinical support, that are needed to take care of children with complex aerodigestive needs. These children have conditions that make it difficult for them to breathe, speak, and swallow. “As one of the busiest programs in the United States, we offer the most cutting-edge diagnostic and therapeutic options available anywhere in the world,” says Douglas Sidell, MD, FACS, pediatric otolaryngologist and director of the Aerodigestive and Airway Reconstruction Center at Stanford Medicine Children’s Health. “Each of our providers has specialized training in aerodigestive disorders, advanced interventional endoscopy procedures, and voice and swallowing problems in children. We’re extremely proud that our work is being recognized.” The Aerodigestive Center treats patients with conditions of the upper airway (larynx and trachea) and upper gastrointestinal tract, as well as pulmonary disorders (involving the lungs/lower airways). Many times, these conditions involve each of these overlapping organ systems, which require several specialists. Generally, that means multiple clinic visits, diagnostic studies, and procedures. It can be difficult for families and providers, so Stanford Medicine Children’s Health brings all specialists together under one roof. “We work to understand the patient and their condition even before they are seen in our clinic to coordinate and streamline care,” Dr Sidell says. “After gathering information about the child and their medical history, all specialists on the team review and create an itinerary for the family. They then schedule an appointment to see each of the specialists together in our one dedicated clinic. If an operative evaluation or intervention is needed, this is scheduled with all providers for a single visit.” The team consists of specialists from otolaryngology–head and neck surgery (ENT), pulmonary medicine, gastroenterology, pediatric cardiology, pediatric surgery, and speech and language pathology to provide the highest quality of care. “Our dedication is to our patients—they’re in this with us, and we’re in this with them,” says Dr Sidell. “Each child is an individual, and we treat them with this at the front of our minds. We love what we do, and I think that translates directly into the care that we provide every day.”

Pulmonary Artery Denervation Takes Next Step in Hypertension


Pulmonary artery denervation (PADN) plus a phosphodiesterase-5 inhibitor improved exercise capacity, cardiac function, and some clinical outcomes in patients with pulmonary artery disease. The primary outcome of change from baseline in 6-minute walk distance increased in both groups at 30 days, with a median change at 6 months of 61 meters with denervation and 18 meters with sham (P = .04). The adjusted mean difference between groups was 33.8 meters in favor of the PADN (95% CI, 16.7 – 50.9; P < .001). Walking distances did not improve in low-risk patients based on REVEAL scores while intermediate- to high-risk patients had “extremely high gain” of 81.4 meters versus 32.5 meters with sham treatment (P = 0.007), lead investigator Shao-Liang Chen, MD, reported in a late-breaking session at Transcatheter Cardiovascular Therapeutics (TCT) 2022. There were no procedural complications in either group. Chest pain was more common in the PADN group but was mild and did not require analgesia. “Treatment with PADN plus a PDE-5 inhibitor is very safe and significantly improves exercise capacity at 6 months compared with sham treatment,” said Chen, Nanjing First Hospital, Nanjing Medical University, China. Previous observational studies, including TROPHY 1have shown that pulmonary artery denervation improves hemodynamic and exercise capacity in patients with PAH, but its efficacy and safety have not been studied in a randomized trial, he noted.

E U Approves First Biologic for Severe Uncontrolled Asthma


The European Commission has approved tezepelumab (Tezspire, AstraZeneca) as an add-on maintenance treatment for patients 12 years and older who have severe asthma that is inadequately controlled with high-dose inhaled corticosteroids and another drug product. "With the European approval of Tezspire, a first-in-class biologic acting at the top of the inflammation cascade, we have an opportunity to treat a broader population of patients with severe asthma, fulfilling a high unmet need in this disease," according to Guy Brusselle, MD, PhD, Department of Respiratory Medicine, Ghent University Hospital, Belgium, as quoted in the AstraZeneca press release.

Respiratory Therapy Proud to Add Dr Salomay Corbaley to its Editorial Advisory Board


Health journal Respiratory Therapy today announced the addition of healthcare executive Dr Salomay Corbaley to its respected Editorial Advisory Board. Dr Corbaley, EdD, MBA, RRT-NPS, AE-C, has been a leader in the ventilation field.

“We are immensely proud to add someone as respected and accomplished as Dr Corbaley is to the Editorial Advisory Board of Respiratory Therapy,” said Steve Goldstein, Publisher of Respiratory Therapy. “With long-term respiratory impacts of COVID-19, the field of Respiratory Therapy is more important now than ever and our publication is dedicated to offering cutting-edge insight into how health-care professionals are handling this crisis. Dr Corbaley will help us achieve this mission.”

As the ventilation and airway program manager for Nihon Kohden American (NKA), Dr Corbaley developed and launched Nihon Kohden America’s ventilation and airway program from Food and Drug Administration (FDA) approval to commercial launch. From healthcare system experience leading teams of more than 100 practitioners to navigating global medical device companies as a trusted clinical partner and resource, Dr Corbaley infuses her leadership approach with a commitment to ongoing professional development, integrity, transparency, and mutual accountability that engenders cross-functional buy-in for thoughtful program design, development, and implementation. Dr Corbaley has led numerous clinical studies as both a clinical marketing leader and a respiratory therapy practitioner.

Company Celebrates 50 Years of Ventilators


Many of the innovations in mechanical ventilation that we take for granted today are the result of the long history and proud legacy of the Servo Ventilators, formed 50 years ago. Groundbreaking technology, a passion for innovation and partnerships with visionary clinicians are some of the things that have made these advancements possible. These, and our passion for life are what guide us each and every day in our never-ending quest for the next generation of ventilation technology. The University Hospital of Lund, Sweden is known for groundbreaking innovations from echocardiography (Edler/Hertz) to the single-use artificial kidney (Alwall). This institution similarly takes pride in its historic respirator developments, a few of which are the Barospirator (an iron lung variant, 1920), the Sahlin-Stille cuirass-respirator (1930) and the Lundia-respirator (1953). Sweden's rich history of respirator development also includes the Stockholm-developed Spiropulsator (1936), the first electric respirator integrated into an anesthesia apparatus, and the Engstrom respirator, used for the first time during the 1952 polio outbreak in Copenhagen. The Engstrom design, the first volume-controlled ventilator, initiated the paradigm shift from negative-pressure iron lungs to the current standards of positive-pressure ventilation. In 1965, Professor Sven Ingelstedt at the Department of Clinical physiology granted a request from the young doctor Björn Jonson to develop a new respirator. Sven's directive included a somewhat ambigious stipulation that would prove historic in retrospect. “Respirators are pressure or volume controlled. They should be flow controlled. Then we could do what we want! P.S. It is not possible to control flow!” The core project team was later completed with the additions of anesthesiologist Dr Lars Nordström and the ambitious electrical engineer Sven-Gunnar Olsson. Olson had been previously employed by Elema-Schönander, a company outside Stockholm famous for having invented the electrocardiogram inkjet printer (1948) and the implantable pacemaker (1958). The project was given a wide degree of freedom for experimentation in an environment that fostered cross-institutional teamwork and entrepreneurship. The Servo Ventilator 900 became a world’s first and fulfilled Sven's directive – a ventilator that was indeed flow-controlled and could provide respiratory monitoring of vital parameters and gas delivery. The Servo 900 featured the Servo Control System, a small, silent, electronic device that enabled the clinician to reliably achieve set tidal volumes by delivering accurate flow to the patient, independent of changes in resistance and compliance from the patient ́s respiratory system. The term Ventilator was introduced to emphasize that it involved new principles surpassing the old respirators. These new ventilator principles gave clinicians new options to provide optimized ventilation methods for each patient, from adults to infants. The brain of the Servo Ventilator was the unique Servo control system, state of the art electronics that contributed to far greater flexibility in operation and choices for modes of ventilation. Pressure and flow sensors utilizing a very small compressible volume in the patient gas delivery circuit fed information back to the inspiratory and expiratory valve units several hundred times per second. Visual and audible alarms were immediately activated if pre-set limits for airway pressure and expiratory minute volume were exceeded.

1973 - Lung mechanics calculation
Integrated monitoring capabilities of the Servo ventilator were a true clinical breathrough. The Lung Mechanics Calculator 940 provided six different parameters and served as an aid in choosing the ventilator settings on a breath-by-breath basis. As an example, this calculator could assist in determination of optimal settings of the external PEEP-valve to achieve the best effect on end-expiratory lung volume and oxygenation.

The Servo ventilator also made recording and data export possible. This data export capability made the Servo the ventilator of choice for research in mechanical ventilation, a steadily increasing area of interest in scientific publications of the 1970s.

1974 - Carbon dioxide analysis
In the ICU, there was a need to continuously measure CO2 as a surrogate for the arterial blood gas pressure PaCO2. This was considered to be time-consuming and expensive. The CO2 Analyzer 930 was the first commercial volumetric capnograph , and was based on measurement of IR light absorbtion in a small, fast mainstream sensor connected to the ventilator. This provided real-time breath-by-breath end-tidal CO2 concentration, CO2 tidal minute elimination, and deadspace calculations. It provided an invaluable contribution to guidance of ventilator settings and to the understanding of severity of pulmonary disease, gas distribution in the lungs, circulation and metabolism.

1976 - Servo Ventilator 900B
The successor to the Servo 900 came to be known as the Servo 900B. It introduced an Intermittent Mandatory Ventilation (IMV) mode synchronized to the patient's respiratory efforts. The patient was, in turn, encouraged to take over more and more of the respiratory workload. The result of this synchronized effort was that weaning process became less painful, both physically and mentally.

Additional features such as CPAP capability, extended setting ranges and the default “green settings” were implemented on the device's front panel.

Neonatal and pediatric possibilities gained notice. Hospitals around the world began to recognize that the Servo ventilator was not designed solely for adults. Unlike most ICU ventilators of the time, the Servo offered options for ventilation of children and newborn babies.

1981 - Servo Ventilator 900C
The Servo 900C was introduced in 1981 as the “Limitless Servo Ventilator System”. Like its predecessors, the 900C had been designed to be easy to learn, set, place, clean and service. It was the first ventilator on the market which  could truly control airway pressure precisely throughout inspiration and expiration.

Electronic control of PEEP and eight different ventilation modes, also available in an accentuated infant patient range, were now available. CPAP could now be delivered through the ventilator with supervision of minute ventilation and CO2 exchange.

Extensive training material (“The Servo University”) with application booklets, a demonstration simulator panel, a deck of patient cards, videos and a clear and consistent operating manual were integral parts of the limitless program.

1981 - Pressure Control (PC)
Originally named Servo Pressure Control Ventilation, this delivery of constant inspiratory pressure with a decelerating flow pattern was able to prolong the time for gas exchange in the alveoli. It was expected to reduce the risk of barotrauma compared to traditional volume controlled ventilation.

Very high peak pressure was common before the current era of low tidal volume ventilation. Pressure Control also quickly gained popularity for use with uncuffed pediatric and neonatal patients.

1981 - Pressure Support (PS)
Pressure Support was introduced to the intensive care world in the Servo 900C. Less than 10 years after its inception, Pressure Support Ventilation became the new standard mode for weaning. It was an important step in allowing the patient to take increased control of the timing of the ventilatory support while the ventilator took over most of the respiratory work. Servo engineers worked with several criteria to solve the timing problem, and finally concluded that the flow decay during a pressurized breath was likely the ideal variable to use. Breath termination at 25% of the peak flow was determined to be the most comfortable level of support. Research on the potential clinical benefits of Pressure Support immediately took off and became a major topic in scientific articles for many years to come. Magnetic Resonance Imaging (MRI) was a novel and revolutionary imaging technique first emerging in the early 1980’s. The powerful electromagnet in the environment required by the technology was a challenge for the construction of the MR-suite and also for equipment that was brought in. Devices that could malfunction in a strong magnetic field could pose a serious risk. Many patients in need of an MRI examination also required mechanical ventilation. The Servo 900C had few magnetic parts, and was the first ventilator that was released for use in this environment. It has later been followed by MR-versions of the latest Servo ventilator generations, including the Servo-u MR Conditional.

1991 - Servo Ventilator 300
The Servo 300 series represented a significant technological advancement and a quantum leap into the microprocessor era as the first universal ventilator enabling treatment of all patient categories, from adults to tiny premature neonates. It included a completely new and unique gas delivery system with gas modules for air and oxygen and a small mixing chamber. The new sensitive flow-triggering system with rapid flow response gained substantial interest due to its ability to reduce work-of-breathing. Servo 300 also set a new benchmark for tidal volume delivery, delivering volumes as low as 2 ml. With each new generation of Servo ventilators, each cycle of invention and innovation, there has been an inherent drive to develop ventilation modes that would meet the changing and challenging clinical needs of the future. The Servo 300 launched a set of volume-target modes - Pressure Regulated Volume Control (PRVC) and Volume Support (VS), modes where the key principle was to deliver the set volume at the lowest required inspiratory pressure targeted on a breath-by-breath basis. Neonatal and pediatric ICUs quickly embraced volume-targeted ventilation as it became clear that this innovation would offer a long desired transition away from less precise and less predictable pressure-limited continuous flow ventilation modes. Servo 300 was, for a time, available in a unique model designed to address a growing interest in nitric oxide (NO) therapy. NO was seen as a potent vasodilator to improve oxygenation in very severe patient groups including prematures with pulmonary hypertension. NO delivery and monitoring were fully integrated into this special 300 model, and a third gas module provided precise NO dosing in full synchrony with breath delivery. Unfortunately, due to an exclusive patent held by a Swedish gas manufacturer for the medical use of NO for treatment of lung dysfunction, production of this then-unmatched Servo 300 NO delivery system was forced to be discontinued.

1996 - Automode
In the ongoing search for gentler, more patient-friendly ventilation, the next innovation was the Automode function, developed to form a bridge between controlled and spontaneous ventilation in the early weaning process. Automode incorporated three combinations of control and support modes, and its automatic switching back and forth between modes was seamlessly supervised by an adaptive apnea time algorithm. The benefits were clear - reduced sedation requirements, less need for operator intervention and fewer alarms. Weaning could be started earlier and patient activity was consistently rewarded without requiring intervention from the staff. The front of the Automode brochure optimistically stated “Weaning begins with intubation".

1998 - Open Lung Tool
Research with the goal of reducing ARDS incidence and mortality heralded the implementation of the Open Lung Tool which, by using breath-by-breath trends of parameters including dynamic compliance and CO2 elimination, provided quantification of the effect of interventions - in particular alveolar recruitment maneuvers. Through a stepwise approach that included a decremental PEEP titration, the PEEP setting could now be personalized to achieve improved oxygenation with ventilation at the lowest possible driving pressure and with a homogenous lung volume. The Open Lung Tool would also indicate when lungs were not recruitable, suggesting that other approaches should be considered and evaluated.

1999 - Neurally controlled ventilation
In December 1999, a new dimension of ventilation technology was presented in the journal Nature Medicine. A group lead by Dr. Christer Sinderby at the University of Montreal described how progress in signal acquisition and processing of the electrical activity of the diaphragm (Edi) meant that these signals could used to allow the patient's own respiratory center to assume full control of the timing and magnitude of the respiratory support provided by the ventilator. Establishment of full patient-ventilator synchrony and use of intrinsic lung-protective reflexes provided new hopes and possibilities for adult and pediatric intensive care ventilation for the 21st century. The vision in this article outlined reduction of ventilator-related complications, facilitation of weaning in order to decrease ICU and hospital length of stay. Visionary Servo engineers grasped the potential of this technology and immediately developed a practical working implementation, which was initially deployed on a Servo 300-based prototype.

2001 - Servo-i Ventilator System
As the culmination of unprecendented cooperation with clinicians worldwide, Servo-i became first ventilator designed as a mobile and modular platform, designed to easily bring new clinical functionality and upgrades to already-installed ventilator fleets. The innovative modular system approach included three main configurations - Infant, Adult and Universal. New levels of flexibility in placement, handling and support during intrahospital transport were offered through a comprehensive range of smart accessories and uninterrupted connectivity. The user interface now allowed clinicians to choose between touch screen, a main rotary dial and direct access knobs, all providing secure control of the most vital settings. The clear flatscreen display provided up to five color-coded high-resolution waveforms with diagnostic quality. The new one-piece Expiratory Cassette met increasing customer demands related to reliability and re-processing, and introduced a brand new technology seen for the first time in Servo ventilators:  Time-of-flight Ultrasound. Its ultra-fast flow measurement was virtually independent of gas composition and humidity. The success of the ultrasonic flowmeter also lead to the development of an Ultrasonic Oxygen Sensor, meant to function over the lifetime of the ventilator. The technology was later found to be effective for detection of the low density Heliox gas mixture when Heliox was latter was implemented as the third supply gas for the Servo-i.

2003 - Servo-s Ventilator System
Servo-s, with its tagline of "Simplicity makes sense", took the cutting edge technology from its big brother Servo-i and consolidated it into a straightforward and cost-effective package. The simplified Servo-s was appropriate for a variety of hospital ventilatory care settings, and in combination with the quiet and compact Compressor Mini was able to deliver high-quality ventilation independent of central wall gas. The user-friendly simplicity, state-of-the-art performance and reliability for both adult and pediatric patients made the Servo-s an instant success in the emerging BRIC economies (Brazil, Russia, India and China) searching for high-value medical devices when modernizing their healthcare systems.

2007 - NAVA (Neurally Adjusted Ventilatory Assist)
The introduction of NAVA in Servo-i was nothing short of a sensation! Featuring plug-in HW and SW modules as well the an Edi catheter with the secondary function of a nasogastric feeding tube, the NAVA Servo-i brought neurally controlled ventilation to an already-respected and popular ventilator. Recent scientific papers had demonstrated the deleterious effects of patient-ventilator asynchrony, as well associated problems due to increased sedation and VIDD (ventilator-induced diaphragm dysfunction). Since those findings and the introduction of NAVA in Getinge ventilators, NAVA has been shown to address these problems by both shortening the time of mechanical ventilation and increasing the number of ventilator-free days by providing personalized ventilation that is both lung- and diaphragm-protective.

2010 - NIV NAVA
As NAVA when compared to traditional ventilation modes is independent of leaks, the application of non-invasive ventilation (NIV NAVA) was a natural step to take as a paradigm shift in treatment to patient groups that had been traditionally treated with more invasive modes. NIV NAVA's continuously growing application in neonates has been tremendous. Its success is based on findings that it may prevent intubation entirely, or allow early extubation when compared to conventional NIV modes which are not sufficiently synchronized. Another patient group that may benefit are adults with acute exacerbation of COPD, in which NIV NAVA has been shown to reduce NIV complications, and may be effective in managing the patient's status.

2014 - Servo-u Ventilator System
Every new generation of Servo Ventilator has had high expectations of transforming how ventilators are perceived within healthcare settings. Servo-u successfully introduced a highly intuitive all-touch user interface with context-based guidance and workflows, recommendations and shortcuts. The objective of this user experience design was to make implementation of advanced ventilation strategies easier to implement in daily practice through enhanced user confidence. New important monitoring parameters, such as VT/PBW and Driving Pressure were implemented, both continuously visualized in the Servo Compass interface. New options for personalized lung protection and weaning for treatment of all patient categories, from neonates to adults were added. A comparative study of ventilator usability showed higher levels of patient safety and a superior user experience with the Servo. Servo-n was purpose-designed as an all-in-one neonatal ventilator to help provide vulnerable neonates with the support they needed while protecting the lungs, respiratory muscles and other developing organs. Dedicated exclusively to neonatal ICU’s and engineered to build confidence for parents and caregivers, it includes aesthetic details like the pediatric-friendly green ladybug casing and a unique Family View. Compensation for variable leakage in all invasive modes, an optional hot-wire flow sensor as well as the integrated option to run High Flow oxygen therapy had been added. NAVA and NIV NAVA are standard modes, the continuous Edi signal playing an essential role in monitoring and managing apnea of prematurity in order to prevent desaturation and bradycardia.

2015 - Servo-air Ventilator System
The Servo-air was the first turbine-driven Servo Ventilator with powerful “hot-swappable” battery backup, making it easy to move around the hospital without requiring wall gas or power outlets. With its plethora of Servo legacy functions and gentle and sensitive non-invasive ventilation (NIV) modes, Servo-air was and is ideally suited for intensive and intermediary care as well as intra-hospital transportation. Servo-air proudly carries the Servo Ventilator heritage further in terms of quality, reliability, performance, ease of use and low cost of ownership.

2019 - Automatic Stepwise Recruitment Maneuver
After a number of promising clinical studies that utilized Servo-i with the Open Lung Tool for stepwise lung recruitment maneuvers according to the Open Lung approach, the longstanding dream to develop an automatic workflow finally came to fruition. Key benefits with a standardized approach were to reduce the significant variation in clinical practice that user interviews revealed. The possibility of integrating diagnostic features which could suggest if the patient was a“recruiter” or a “non-recruiter” may have a profound effect on ventilation strategy. Auto SRM guides the user smoothly through recruitment, decremental PEEP titration, re-recruitment and post-recruitment personalization of PEEP and driving pressure based on optimal Cdyn. Increased focus can be placed on finding the optimized balance between the patient's lung mechanics, gas exchange and hemodynamics. Esophageal manometry had, in the 2010s, experienced something of a scientific renaissance, but was found to be difficult to implement in routine clinical use outside of a research setting. To make this technology more accessible and easy to understand and to improve accuracy, a diagnostic view was developed for the Servo-u that presented esophageal (Pes) and transpulmonary (PL) pressure waveforms with key parameters for assessment of controlled and spontaneous ventilation. In addition, an automatic occlusion maneuver was invented to validate balloon positioning and filling. This new tool for personalized lung protection has been used extensively during the Covid-19 pandemic, and it has been reported that it is now poised to be implemented in routine clinical practice.

The Servo ventilator isn’t just an engineering marvel. It’s a philosophy. A mindset, intrinsic in our DNA. It’s this conviction that has driven our pursuit in discovering new techniques for the treatment of critically ill patients. We are constantly evolving and reinventing our therapies and innovative solutions with the aim of helping wean the patient off the ventilator as quickly and safely as possible. The goal is better patient outcomes while simultaneously conserving medical resources. It’s an ambition that has remained with us from the very start, and it’s a way of thinking predominant in everything we do today. Innovation, reliability, enduring quality—doing more with less. Qualities we build into every one of our Servo ventilators produced today. It’s these same qualities that will define tomorrow’s Servo ventilators, in today’s unpredictable world. It’s how we’ve written our history. And it’s how we’ll shape our future.

Company’s Smallest Diagnostic Spirometer Launched


Detailed diagnostic spirometry is now simpler than ever, thanks to Vitalograph’s micro spirometer, which offers exceptional test accuracy and has a large touch screen for real-time test guidance and results interpretation. The sleek and compact design of the micro is perfect for mobile testing: it features a 325-test subject memory, and Bluetooth connectivity for effortless communication with other devices and healthcare apps. It also has an optional detachable flowhead, which makes it even easier to view data during testing and is an effective option for creating distance between subject and tester, if required. The micro offers multiple spirometry testing options, such as FVC, SVC and bronchodilator responsiveness, all in compliance with ATS/ERS 2019 Guidelines. Andy Roebuck, micro Product Manager says: “The micro brings Vitalograph’s quality and test accuracy to a device that is much smaller and more portable than ever before. It is affordably priced and extremely simple to use, and that helps to bring high-quality spirometry to more healthcare professionals and their patients.”

EU Panel Backs New Drug for Infant Immunization of RSV


The European Medicines Agency's human medicines committee on Friday recommended marketing authorization for an immunization against respiratory syncytial virus (RSV) for newborns and infants. The agency's Committee for Medicinal Products for Human Use (CHMP) based its positive opinion for Beyfortus (nirsevimab) for prevention of lower respiratory tract infections linked to RSV, the leading cause of hospitalization among infants. The US Food and Drug Administration granted nirsevimab (MEDI8897 in the United States) a breakthrough therapy designation in February 2019, although the product is still in the clinical trials stage and has not received marketing approval. RSV is the leading cause of lower respiratory tract infections in infants, according to a press release from AstraZeneca and Sanofi, which are jointly developing the vaccine. Worldwide, acute lower respiratory infections associated with RSV account for about 1.4 million hospitalizations and 27,300 in-hospital deaths among infants under age 6 months annually, according to the World Health Organization. The highly contagious virus is also a concern for adults with compromised immune systems and older people with underlying health conditions, who are at increased risk for severe disease. Nirsevimab is a long-acting antibody given as a single intramuscular injection at a dose of 50 mg for infants with a body weight of less than 5 kg, and 100 mg for infants weighing at least 5 kg. The European authority based its positive opinion on results from several trials, including the phase 3 MELODY study of nearly 1500 infants, which reported a reduced incidence of medically attended lower respiratory tract infections associated with RSV with nirsevimab of 74.5% versus placebo (95% CI, 49.6, 87.1; P < .001).  "Today's positive CHMP opinion is one of the most significant public health achievements in respiratory syncytial virus in decades and has the potential to alleviate the enormous physical and emotional burden that RSV can place on families and healthcare systems," Jean-François Toussaint, PhD, global head of research and development vaccines at Sanofi, said in a statement about the committee recommendation. "With this endorsement, we are one step closer to achieving our goal of protecting all infants against RSV with a single dose." The recommendation will now be reviewed by the European Commission. If approved, nirsevimab will be the only preventative option for the broad newborn and infant population, according to AstraZeneca and Sanofi.

Hyperbaric Oxygen Treatment Helps Long Covid Patients, Study Says


Long COVID-19 patients who received pure oxygen treatments saw improvements to damaged brain tissues and their functional cognition compared to others in a study who received regular air, researchers in Israel say. Some COVID-19 patients suffer from “brain fog,” and research links the disease to tissue damage and brain shrinkage. The hyperbaric oxygen experiment was designed to see whether it could be effective for COVID-related brain issues. Shai Efrati, a researcher at the Sagol Center for Hyperbaric Medicine in Tel Aviv, started clinical trials in December 2020, according to COVID-19 patients with cognitive issues received 40 sessions of therapy in a special hyperbaric chamber over a period of 60 days. In each session, they spent 90 minutes breathing through a mask. One group received pure oxygen; the control group received normal air, which has less oxygen. Results published by Scientific Reports revealed substantial improvements in damaged brain tissue and functional cognition for the participants who breathed the pure oxygen. Most also said they felt back to “normal.” Up to 12 patients and medical staff can fit inside the hyperbaric chamber. Leaps says it resembles a pressurized airplane cabin, “only with much more space than even in first class.” Efrati said the environment is a “medical class center.” Alexander Charney, MD, a research psychiatrist at the Icahn School of Medicine at Mount Sinai in New York City, told Leaps that the study could be difficult to replicate in large scale. But he said it was interesting enough to warrant further study. John J. Miller, MD, editor in chief of Psychiatric Times, said the research “has great potential to help patients with long COVID whose symptoms are related to brain tissue changes.”

Biomarker-Guided Steroid Therapy Shown Safe for COPD


Eosinophil-guided corticosteroid therapy for patients with chronic obstructive pulmonary disease (COPD) is equivalent in efficacy to standard of care therapy, but the eosinophil-guided therapy may help mitigate the harmful side effects associated with even short courses of corticosteroids, investigators said in a primary care-based randomized trial. Among patients in 14 primary care practices in the UK who experienced COPD exacerbations, the proportion of patients who experienced treatment failure at day 28 was 27% for those who were randomized to receive prednisolone only when blood eosinophil counts on a point-of-care assay equaled or exceeded 2%, compared with 34% of all patients randomized to standard of care. The relative risk for treatment failure using the eosinophil-guided approach was 0.82, which did not reach statistical significance, but indicated noninferiority for the biomarker-based dosing method, reported Mona Bafadhel, MD, from King’s College London, United Kingdom, on behalf of colleagues in the Stratified Treatment to Reduce Risk in COPD (STARR2) trial. “The STARR2 trial showed that eosinophil-guided prescription in primary care is safe and is not associated with worsening outcomes. This is the largest primary care multicenter trial, and probably adds another 20% to the literature base for exacerbations in COPD,” she said in an oral abstract presentation at the European Respiratory Society (ERS) 2022 Congress. “A personalized endotype-based treatment with oral prednisolone is possible in patients with COPD and I think should be now part of clinical guidelines,” she added.

Service Network Expanded


In response to increased demands on oxygen equipment fleets, CAIRE has announced Repair Authority, the largest home medical equipment repair company in the US, has officially become a part of the company’s Authorized Service Center network. Based in Strongsville, OH, Repair Authority has long been a CAIRE customer performing out of warranty repairs to its equipment. Through this new agreement, Repair Authority will be able to support CAIRE customers with in-warranty repairs, which is critical support needed by some of the largest home medical equipment (HME) providers. Founded in 1990, Repair Authority is one of the oldest and most widely respected home medical equipment repair companies in the US. Originally known as The Repair Center (TRC), Repair Authority has repaired nearly a million units over its history, serving HME dealers ranging from large national companies to smaller independent providers. In addition to stationary and portable oxygen concentrators, the company also repairs continuous positive airway pressure (CPAP) devices, ventilators and other home respiratory equipment at its 53,000-square-foot headquarters. Repair Authority holds more authorized warranty service contracts than any other HME repair provider in the US. Because of this, the organization has played a major role over the past two years performing critical equipment repairs during the COVID-19 pandemic. “We’re honored to have been selected by CAIRE as an authorized service provider for its stationary and portable oxygen concentrator lines,” said Jesse Keirn, CEO of Repair Authority. “CAIRE’s reputation for quality and innovation is second to none, and we are proud to partner with them to keep their devices working properly and in patients’ homes where they belong.” Repair Authority serves dealers nationwide, and offers pickup and delivery routes in Ohio, Michigan, Indiana, Kentucky, West Virginia and Pennsylvania. Outside of those routes, customers ship their equipment to the company’s Ohio facility. “Offering regular delivery routes in these six states is one of the major benefits of partnering with Repair Authority,” said Lanier Hogan, CAIRE Global Parts and Services Manager. “The convenience of their location, along with a faster turnaround, will have a direct impact on CAIRE’s providers who will be able to enhance their customer service to ensure their oxygen users enjoy a better quality of life.” Repair Authority joins ReOx Medical Services, Altra Services Professionals, and Oxygen Sales &amp; Service, Inc. in providing support for CAIRE equipment as part of the Authorized Service Center network in the United States. These sites complement CAIRE’s new Global Service Headquarters in Canton, GA.

Interview Highlights MediPines AGM100’s 99% Accuracy

AUGUST 30 2022

In a video interview on “Hot Topics in Emergency Medicine” posted by Medscape, a group of emergency medicine experts and respiratory physiology thought leaders discussed a new non-invasive measurement; Oxygen Deficit, obtained from the MediPines AGM100, which demonstrated 99% clinical accuracy for supplemental oxygen therapy decisions. The interview was moderated by Robert D. Glatter, MD (emergency medicine physician), and featured John B. West, MD, PhD (emeritus professor of medicine and physiology at UCSD School of Medicine) and W. Cameron McGuire, MD, MPH (pulmonary critical care physician and instructor at UCSD School of Medicine), as they discussed data from their recent study presented at the American Thoracic Society (ATS) International Conference 2022. The study demonstrated that Oxygen Deficit, which is a measurement of respiratory impairment, had very high predictability in two areas: 1) determining a patient’s need for supplemental oxygen and 2) guidance of hospital admission decisions. Dr McGuire stated that the predictive power of the Oxygen Deficit (OD) measurement was very high, sharing that “…an oxygen deficit of 40 (mmHg) or above predicted a need for supplemental oxygen at some point during that hospital course with, essentially, 99% accuracy.” This discovery comes at a time when appropriate and accurate administration of oxygen therapy is crucial with the COVID-infected population. Dr Glatter described what he viewed as one of the biggest challenges: “Obviously, silent hypoxemia or occult hypoxemia is a real issue, especially in patients with COVID-19. This is applicable with that patient population but also in other patients with chronic obstructive pulmonary disease (COPD), asthma, people with idiopathic pulmonary fibrosis (IPF), and other types of lung pathology.” “I personally think (the technology) has a tremendous future because it is very simple to use,” said Dr West. “It is very simple for the patient. There’s no arterial puncture. I can remember vividly our problems with arterial puncture during my (time) as a physician. It has the advantage of looking both at the blood side and the gas side.” The MediPines AGM100 is the world’s first and only medical device which delivers Oxygen Deficit and as a result has been growing in usage for COVID-19 and other cardiopulmonary patients. Healthcare providers are seeking a reliable, discriminative tool during times of surging respiratory patients and medical staff shortages. “We are delighted to see our innovation providing useful clinical measurements in emergency medicine in times of great need” said MediPines CEO, Steve Lee. “Furthermore, our proprietary technology continues to prove its powerful effectiveness and practical value in helping clinicians manage patients to better outcomes in emergency departments and throughout the continuum of patient care.” The video and transcript of the discussion can be viewed in full here:

Vaccine Hopes for RSV, Leading Cause of Death in US Infants

AUGUST 30 2022

Respiratory syncytial virus (RSV) is the leading cause of US infant hospitalizations overall and across population subgroups, new data published in the Journal of Infectious Diseases confirm. Acute bronchiolitis caused by RSV accounted for 9.6% (95% confidence interval, 9.4%-9.9%) and 9.3% (95% CI, 9.0%-9.6%) of total infant hospitalizations from January 2009 to September 2015 and October 2015 to December 2019, respectively. The latest issue of the journal includes a special section with results from 14 studies related to the widespread, easy-to-catch virus, highlighting the urgency of finding a solution for all infants. In one study, authors led by Mina Suh, MPH, with EpidStrategies, a division of ToxStrategies in Rockville, Md., reported that, in children under the age of 5 years in the United States, RSV caused 58,000 annual hospitalizations and from 100 to 500 annual deaths from 2009 to 2019 (the latest year data were available). Globally, in 2015, among infants younger than 6 months, an estimated 1.4 million hospital admissions and 27,300 in-hospital deaths were attributed to RSV lower respiratory tract infection (LRTI). The researchers used the largest publicly available, all-payer database in the United States — the National (Nationwide) Inpatient Sample — to describe the leading causes of infant hospitalizations. The authors noted that, because clinicians don't routinely perform lab tests for RSV, the true health care burden is likely higher and its public health impact greater than these numbers show. There are no preventative options currently available to substantially cut RSV infections in all infants, though immunization candidates are advancing, showing safety and efficacy in clinical trials. Palivizumab is currently the only available option in the United States to prevent RSV and is recommended only for a small group of infants with particular forms of heart or lung disease and those born prematurely at 29 weeks' gestational age. Further, palivizumab has to be given monthly throughout the RSV season. Another of the studies in the journal supplement concluded that a universal immunization strategy with one of the candidates, nirsevimab (Sanofi, AstraZeneca), an investigational long-acting monoclonal antibody, could substantially reduce the health burden and economic burden for US infants in their first RSV season. The researchers, led by Alexia Kieffer, MSc, MPH, with Sanofi, used static decision-analytic modeling for the estimates. Modeled RSV-related outcomes included primary care and ED visits, hospitalizations, including ICU admission and mechanical ventilations, and RSV-related deaths. "The results of this model suggested that the use of nirsevimab in all infants could reduce health events by 55% and the overall costs to the payer by 49%," the authors of the study wrote.

Trials Data on COPD Leave Primary Care Docs in the Dark

AUGUST 15 2022

Primary care clinicians often struggle to care for their patients with chronic obstructive pulmonary disease (COPD), thanks to a lack of real-world evidence as to which treatments work best. As a result, potentially preventable life-threatening exacerbations are common among people with the condition. Central to the problem, some experts believe, is that the average patient bears little resemblance to participants in clinical trials of the medications used to treat COPD. Indeed, a recent study showed that many COPD patients who were receiving maintenance therapy that should have been controlling their disease experienced severe flare-ups ― a finding that caught the researchers by surprise. "We know the benefit of COPD treatments in the context of clinical trials. However, the kinds of patients in primary care may not completely mimic those in clinical trials," one of the authors, MeiLan Han, MD, a professor of medicine in the Division of Pulmonary and Critical Care at the University of Michigan, Ann Arbor, said. Han, a volunteer medical spokesperson for the American Lung Association, added that patients "may not be as adherent to medications in real life as they are in clinical trials." Randomized controlled trials that support regulatory drug approvals typically enroll patients who do not have comorbid conditions, who are younger than the average patient with COPD, and who typically are male. Patients are seen in resource-abundant settings designed to maximize adherence to treatment, with supports such as free medication and frequent monitoring ― settings far different from those in which most primary care physicians practice. The authors of the new article said trials conducted with typical patients in primary care settings could help physicians to optimize treatment.

Breas Medical Releases Extended-life Battery for Vivo Ventilators

AUGUST 10 2022

Breas Medical USA announced the release and immediate availability of the Xpac by Breas extended life battery. The Xpac enhances ventilator dependent patient mobility with boost of battery life of the Breas Vivo 50 and Vivo 65 by 12 hours and the Vivo 45 LS by 18 hours. With Xpac, the ultra-compact and lightweight Vivo 45 LS can now run 25.5 hours off the grid. “Breas is thrilled to provide the Xpac to the ventilator dependent community as a means to enhance quality of life by elimination of the worry of ventilator operation when away from power outlets for extended periods of time, improving the quality of life and ambulatory requirements for the patients we serve.” said Chris Southerland, General Manager, Breas Americas. The Xpac consists of two high powered lithium-ion batteries which can be easily removed and replaced by the user. It’s intuitive LED display shows the health of each battery, so you know when it is time to renew them. In addition, Xpac’s batteries only take 4 hours to charge to full capacity. Engineered in its founding Swedish and USA offices, Breas delivers leading-edge innovations that can provide patient comfort and mobility needed to improve their quality of life.

Nonin Medical Names New Chief Executive Officer

AUGUST 10 2022

Nonin Medical announced that its board of directors has appointed healthcare industry veteran John M. Hastings as its new Chief Executive Officer, effective August 29, 2022. Hastings brings global leadership and technical expertise in quality, research and development, manufacturing, regulatory affairs, engineering, supply chain and distribution, along with a demonstrated ability and passion to develop and advance effective business strategies. As leader of the organization, Hastings, along with the company’s recently named board of directors, offers a diverse and unique set of experiences, combined with a passion for growth and innovation in the medical device and healthcare sectors. Together, they will provide Nonin Medical with strategic guidance and support to drive the company’s growth. “The entire Board is looking forward to working with John as Nonin Medical’s new CEO,” said Phil Isaacson, Nonin Medical’s Executive Chairman, Chief Technology Officer, and Founder. “John is directly aligned with our values of courage, agility, and ownership, and brings a strong belief in ongoing education and professional development. He also shares deep respect for our history, products, and commitment to improving people’s lives – and sees tremendous potential for our technology and Nonin Medical’s future opportunities.” Healthcare technology is playing an increasingly important role in patient management, care and outcomes. Hastings will help Nonin Medical address the needs of a rapidly changing market and its patients, providers, payors and partners, using innovative technology and noninvasive medical solutions. “I sincerely appreciate the board’s confidence in me, and I’m thrilled to have the opportunity to lead this exceptional organization,” said Hastings. “With Phil’s continued pursuit of innovation and our employees’ commitment to our customers, I am highly confident in our future. Together, I look forward to further strengthening our position as a market leader while driving sustainable and profitable growth.” Prior to Nonin Medical, Hastings served as Executive Vice President, Operations & Technology with Cardiovascular Systems, Inc., or CSI, a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. Before joining CSI, he held leadership roles of increasing responsibility at Abbott Laboratories, St. Jude Medical and American Medical Systems. Hastings is a Minnesota native and holds an MBA from the University of Saint Thomas and a degree in Mechanical Engineering from Minnesota State University, Mankato.

New Adapters for Use with Duckbill-style Tracheostomy Tubes

AUGUST 4 2022

Passy-Muir, Inc. announced the release of two new products specifically designed for use with the new duckbill-style inner cannula tracheostomy tubes. The 15mm DigiSil Digital (Finger) Occlusion Adapter is a non-sterile, lightweight, single patient use, stretch-to-fit adapter for placement on the 15mm hub of a tracheostomy tube with a duckbill designed inner cannula to allow finger occlusion. The DigiSil adapter facilitates easy finger occlusion and comes with a PMV Secure-It, which secures the adapter to a patient’s tracheostomy tie to prevent loss. The PM-DB15 Adapter is a non-sterile, lightweight, single patient use, low-profile adapter for placement on the 15mm hub of a tracheostomy tube with a duckbill designed inner cannula to allow finger occlusion or placement of a Passy Muir Valve, models PMV2000 or PMV2001. Both products are designed for use in clinical settings, including hospitals, sub-acute, rehabilitation, outpatient, skilled nursing, and long-term care, as well as in the home setting. Each adapter comes with detailed instructions for use, and each is manufactured in the United States. For more information, or to order, visit, or call 1-800-634-5397.

Device Adds Respiratory Flexibility

AUGUST 1 2022

Vitalograph announced Pneumotrac with RMS (Respiratory Muscle Strength) creating multiple respiratory diagnostic flexibility in one powerful device option. The Pneumotrac with RMS is a PC-based system that combines respiratory muscle strength measurements and spirometry – offering multiple testing possibilities on a single device that is as portable as your laptop. It can be used in various environments such as an in-clinic desktop, or it can be placed on a cart with a laptop for mobile use. The Pneumotrac with RMS creates a powerful, flexible, and reliable respiratory diagnostic functionality, particularly for COPD or neuromuscular diseases, at a relatively low cost. Alongside detailed spirometry testing, it provides a non-invasive and simple approach to mouth pressure and nasal pressure measurements in both adults and pediatrics. Assess diaphragmatic weakness in patients with neuromuscular disease (NMD). Assess respiratory muscle strength in patients undergoing pulmonary rehabilitation e.g., COPD patients. Monitor the response of respiratory muscle training. Meets 2019 ATS/ERS standardization of spirometry guidelines. Highly accurate, robust, and stable Fleisch flow measuring technology with no moving parts. Low running costs &amp; environmentally friendly: no need for costly disposable sensors, turbines or flow tubes. Save time and money using Vitalograph Bacterial Viral Filters (BVF) with validated cross-contamination efficiency, protecting the device, patient, and operator. Instant quality feedback using the latest test/session acceptability, usability and repeatability criteria. EMR compatible.

New Unit Helps Technology-Assisted Patients Transition Home

AUGUST 1 2022

Technology-assisted respiratory patients at Lucile Packard Children’s Hospital Stanford now have a dedicated program that helps them focus on returning home and continuing their growth and development. The Stanford Technology-Assisted Respiratory (STAR) Program, which opened in August 2022, includes a dedicated team led by pediatric pulmonary providers that focuses on rehabilitation and education to empower the patient and family to take the next step: hospital discharge. The only pediatric program of its kind in Northern California, the STAR Program aims to improve outcomes and patient experience. Before this new program was created, the hospital’s patients with tracheostomies requiring chronic mechanical ventilation were cared for only in intensive care units (NICU, PICU, and CVICU). However, there is a subset of these patients who are on portable ventilators and who are better served in a chronic care setting. This group of patients includes children who are preparing to be discharged home or to a long-term-care facility, children admitted for a nonrespiratory acute illness, or children admitted for an overnight stay after a procedure, such as an MRI that requires sedation. “There’s an older practice in pediatric pulmonary medicine that is focused solely on liberating the patient from the tracheostomy and ventilator,” said Michael Tracy, MD, a pediatric pulmonologist at Stanford Medicine Children’s Health and medical director of the STAR Program, “but now that the technology has improved and ventilators are portable and easier to use, we like to think of the tracheostomy and ventilator as liberating the patient from the hospital so they can get home and focus on growing and developing.” Research suggests that a dedicated multidisciplinary program for tracheostomy-and-ventilator-dependent children may achieve the following: Reduce the length of a child’s hospital stay by focusing on preparing for the transition to home or a long-term care facility. Improve patient satisfaction as the patient gets to know the dedicated care team and feels more comfortable in a less acute care environment. Enhance neurodevelopmental outcomes as the care team prioritizes developmental activities. Decrease hospital readmissions, because a focus on education means that families feel empowered to address emergencies safely at home.Improve survival by standardizing care, providing continuity, and optimizing communication. Patients in the STAR Program will benefit from access to a multidisciplinary team of specialists, including pulmonologists, respiratory care practitioners, occupational and physical therapists, speech-language pathologists, otolaryngologists, gastroenterologists, aerodigestive specialists, cardiologists, surgeons, dietitians, child life specialists, social workers, and case managers. “No one should have to stay in the ICU for longer than absolutely necessary,” said Dr Tracy. “Our goal is to give patients and families a path to safely manage their care at home.”

High Fidelity, Virtual Mechanical Ventilation Training is Coming

JULY 29 2022

For over 25 years, IngMar Medical has provided the respiratory community with highly realistic tools for teaching mechanical ventilation. Historically, these tools required the use of your own real mechanical ventilator in conjunction with our ASL 5000 Breathing Simulator. We are now proud to introduce our new virtual learning environment, RespiSim eLearning. We believe this virtual learning space will help to strengthen learners’ understanding of key mechanical ventilation concepts while paving the way for more effective simulation outcomes, and ultimately better patient care. Subscribers will have the opportunity to run interactive, software-based simulations utilizing the world-renowned ASL 5000 lung modeling technology in conjunction with our new Virtual Ventilator software. Our Virtual Ventilator software allows instructors to demonstrate critical patient-ventilator interaction concepts for remote or in-person learners. Additionally, learners can be given direct access to the Virtual Ventilator software to practice on their own time. Subscribers will also have access to a Learning Management System (LMS) which includes self-guided, e-learning content such as the acclaimed Standardized Education for Ventilatory Assistance (SEVA) curriculum, developed by the Cleveland Clinic. The e-learning courses can be used as an adjunct to current curriculums, and they can act as a self-study tool for your learners. We’re also pleased to announce that successful completion of the SEVA e-learning courses will grant the learner 8 hours of Continuing Respiratory Care Education (CRCE) credit by the American Association for Respiratory Care. Additionally, the LMS platform includes a discussion forum where respiratory educators can share best practices and insights on key topics in mechanical ventilation and respiratory simulation. IngMar Medical believes that building a community of respiratory educators all over the world will lead to more standardization and ultimately better training outcomes. RespiSim eLearning represents a major step in the direction of building this community, and it demonstrates our commitment to providing affordable, high quality training solutions for ALL respiratory educators. For more information or to speak with a Product Specialist, contact

Breathe Easier with Spontaneous Breathing Lung Simulator from Michigan Instruments

JULY 26 2022

Michigan Instruments, a leading manufacturer in Lung Simulators, announced the release of their new Spontaneous Breathing Lung Simulator (SBL). The SBL is capable of providing precision-based simulation of a breathing patient to aid in the research, training, and development of non-invasive and supportive modes of ventilation and oxygenation. The Spontaneous Breathing Lung Simulator offers an updated way to create spontaneous breathing. This is available as an independent device or an add-on to the current version of Michigan Instruments’ TLL Training Test Lungs and PneuView systems. The addition of the SBL module, transforms the device into a spontaneous breathing system. “The Spontaneous Breathing Lung has been one of our most requested device capabilities for our Lung Simulators,” said Chris Blanker, owner and president of Michigan Instruments. “We’ve had an alternative option using our Breath Simulation Module, but the Spontaneous Breathing Lung provides an easier way for researchers, educators and developers to access these capabilities on our devices.” While the Spontaneous Breathing Lung is useful in any research requiring breathing, in training settings the Spontaneous Breathing Lung can help educators create a variety of scenarios and breathing patterns that can be used during student education in classrooms and simulation labs. While in testing settings, the simulator can help facilitate troubleshooting and testing of devices meant to operate on spontaneous breathing patients and test various device capabilities. The Spontaneous Breathing Lung is capable of providing users with a variety of real-time data, including: Breath rates of 2 to 30 breaths per minute; Inspiratory Time of .5 to 5.0 seconds in .1 second increments; Breath Volume of 100 – 1,800 ml; Flow Waveform: Square or Sinusoid.

Randomized Controlled Study Finds Masimo SedLine Brain Function Monitoring Can Help Guide Anesthesia

JULY 20 2022

Masimo announced the findings of a randomized, controlled trial published in the Journal of Clinical Anesthesia in which Dr Melody H.Y. Long and colleagues from the KK Women’s and Children’s Hospital in Singapore evaluated the ability of electroencephalogram (EEG)-guided anesthesia, using Masimo SedLine brain function monitoring, to reduce the amount of the drug sevoflurane needed to maintain anesthesia in pediatric patients undergoing minor surgery. They found that use of SedLine to guide anesthesia reduced sevoflurane requirements and led to a reduced incidence of burst suppression, which has previously been reported to be associated with postoperative delirium. Noting the unique nature of pediatric brains, which are still developing, the importance that standard anesthesia practice places on minimizing the dosage of drugs needed to maintain anesthesia, and the lack of research into the use of new technology like real-time EEG spectrogram monitoring in children, the researchers devised a study that would investigate what impact such technology might have. They enrolled 195 children, aged 1 to 6 years, who were scheduled for minor surgery involving general anesthesia induced and maintained using sevoflurane. The children were randomized into either a Masimo SedLine EEG-guided group (n=100) or a standard care group (n=95). In the SedLine EEG group, anesthesiologists used SedLine to help guide administration of sevoflurane, with the goals of maintaining continuous slow/delta oscillations on the raw EEG and spectrogram, avoiding burst suppression, and maintaining a Patient State Index, or PSi – a propriety, processed EEG parameter developed by Masimo – between 25 and 50. In the standard care group, clinicians were blinded to the EEG data. As their primary outcome, the researchers looked at the average end-tidal concentration of sevoflurane used during induction and maintenance of anesthesia. They found that in the EEG group, the concentration was lower both during induction (4.80% compared to 5.67% in the control group, p=0.003) and maintenance (2.23% vs. 2.38%, p=0.005). As one of their secondary outcomes, the researchers compared the incidence and duration of intraoperative burst suppression, and found that the EEG group had a lower incidence of burst suppression (3.1% vs. 10.9% in the control group, p=0.0440). The authors concluded, “This is one of the first randomized control trials in the pediatric population showing that EEG-guided anesthesia care utilizing the spectrogram is feasible, and leads to a modest decrease in intraoperative sevoflurane dosage for induction and maintenance in young children aged 1 to 6 years. EEG guidance allows easy visualization of anesthesia-induced changes on the brain in real time, making it possible to determine which individuals require more (or less) anesthetic to maintain unconsciousness and titrate doses accordingly. This may be particularly important in children between 1 and 2 years old, who appear to require a higher concentration of sevoflurane during surgery, as well as in patients at risk of neurological injury. Our findings highlight the importance of EEG monitoring in complementing the current ASA standard monitors, to provide personalized anesthesia care.” William C. Wilson, MD, MA, CMO and SVP of Clinical Research and Medical Affairs at Masimo, commented, “We believe the significant reduction in burst suppression noted in the EEG group – less than one-third the amount in the control group – is an important finding. In future studies with larger sample pools, this could demonstrate more profound outcome benefits.” In the US, SedLine is currently indicated for pediatric use without the PSi parameter.

Probiotics Improve Physical Function in COPD

JULY 16 2022

Probiotics improve strength and functional capacity in patients with COPD, based on a randomized, placebo-controlled trial. The improvements stem from decreased gut permeability, which reduces circulating inflammatory cytokines, leading to stabilization of neuromuscular junctions, reported lead author Asima Karim, MBBS, PhD, of the University of Sharjah, United Arab Emirates, and colleagues. "The manipulation of gut bacteria with probiotics may be an attractive therapeutic strategy to strengthen the intestinal barrier," the investigators write in Archives of Gerontology and Geriatrics. "Probiotic supplements reduce the pathological translocation of bacterial metabolites and ameliorate the systemic inflammatory state in multiple diseases." In COPD, both intestinal permeability and systemic inflammation have been linked with sarcopenia, suggesting a common, yet unexplored thread, according to Karim and colleagues. "To our knowledge, no previous study has investigated the effects of probiotics on sarcopenia in COPD patients," they write. "However, probiotics are shown to reduce lung inflammation and improve airway remodeling in experimental animal models of COPD." Their trial enrolled 104 men with COPD between 63-73 years of age. Patients were randomly assigned in 1:1 ratio to receive either placebo or a probiotic containing 112 billion live bacteria, including one strain of Streptococcus, three strains of Bifidobacterium, and four strains of Lactobacillus. At baseline and 16 weeks, the investigators measured handgrip strength, short physical performance battery (SPPB), gait speed, and appendicular skeletal mass index. In conjunction, six plasma biomarkers characterized intestinal permeability (zonulin, claudin-3), neuromuscular junction degradation (CAF22), systemic inflammation (CRP, creatine kinase), and oxidative stress (8-isoprostanes). Clinically, probiotic treatment was associated with significant improvements in handgrip strength, gait speed, and functional capacity (SPPB). Concurrently, patients in the probiotic group had significant improvements in gut permeability (zonulin, claudin-3), neuromuscular junction degradation (CAF22), systemic inflammation (CRP), and oxidative stress (8-isoprostanes). In contrast, patients in the placebo group showed no significant changes in clinical picture or biomarkers, apart from zonulin, which increased over time, suggesting worsened gut permeability. Creatine kinase, a measure of systemic inflammation, showed no change in either group.

Ventilator System Receives US FDA Clearance

JULY 5 2022

Nihon Kohden OrangeMed, Inc. received US Food and Drug Administration (FDA) 510(k) clearance for its NKV-330 Ventilator System. The NKV-330 is a non-invasive ventilator that provides respiratory support to adult and pediatric patients. It offers not only non-invasive ventilation but also invasive ventilation as well as high flow oxygen therapy. In addition, it provides continuous monitoring of CO2 when using our cap-ONE NIV mask. The cap-ONE mask is an NIV interface that allows quality CO2 monitoring directly from the ventilator. “The NKV-330 ventilator can help hospitals who face a limited choice of new non-invasive ventilator platforms.” said Dr Hong-Lin Du, CEO of Nihon Kohden OrangeMed. “The continuous monitoring of CO2, the excellent portability, and many other features in the NKV-330 makes it a great choice for the hospitals and caregivers.” The NKV-330 Ventilator System is distributed in the United States by Nihon Kohden America, Inc. and is expected to begin shipping in July 2022. It has been available outside of the United States since 2019.

Higher Hospital Readmission Rates Linked to Adverse Effects in Pneumonia

JUNE 30 2022

Adding to the debate over the value of hospital readmission rates, a new study links the data to higher rates of adverse events in patients treated for pneumonia. For each interquartile range increase in the readmission rate in a sample of 46,047 patients, the odds of adverse events grew by 13% (adjusted odds ratio, 1.13; 95% CI, 1.08-1.17), according to research. "The link between patient safety and overall hospital quality has not been explored in detail. This study supplements that knowledge and more specifically links readmission rate, which has been criticized as a measure of quality, with patient safety," said pulmonologist Mark Metersky, MD, of UConn Health. According to Metersky, it's clear that readmissions are extensive and expensive. "We also know that many are not preventable and that efforts to lower readmission rates have not been highly successful overall, although there have been some positive studies," he said. "We also know that CMS [Centers for Medicare & Medicaid Services] does use readmission rates to adjust payments to hospitals, and many are penalized financially. We do not know how effective financial penalties are in driving quality improvement. In fact, the evidence is not strong." For the new study, he said, the researchers sought to understand more about readmission rates and pneumonia. "Both readmissions and patient safety are associated with the quality of hospital care, but it is unknown whether patients admitted to hospitals with higher risk-standardized readmission rates had a higher risk of in-hospital adverse events." The researchers tracked patients with pneumonia across 2590 hospitals from 2010-2019 (mean age, 71; 52% women; 82% White persons; 12% Black persons; 46% with chronic obstructive pulmonary disease; 7% with in-hospital mortality). "The median hospital-specific risk-standardized readmission rate was 17.0% (95% CI, 16.3%-17.7%), the occurrence rate of adverse events was 2.6% (95% CI, 2.54%-2.65%), and the number of adverse events per 1000 discharges was 157.3 (95% CI, 152.3-162.5)," the researchers reported. In addition to the findings about adverse events in patients, the researchers linked each interquartile range increase to 5.0 more adverse events per 1000 discharges at the hospital level (95% CI, 2.8-7.2). "Patients with pneumonia admitted to a hospital with a high readmission rate were more likely to suffer an adverse event while hospitalized, and hospitals with high readmission rates had higher rates of adverse events among their patients," Metersky said.

IL-6 Antibody Mitigates Mucus Hypersecretion in COPD

JUNE 30 2022

Treatment with an interleukin-6 neutralizing antibody significantly reduced airway mucus hypersecretion (AMH) in chronic obstructive pulmonary disease (COPD), based on data from human and mouse cells in a human organoid model. AMH plays a large part in aggravating airway obstruction in patients with COPD, Yuan-Yuan Wei, MD, of First Affiliated Hospital of Anhui Medical University, Hefei, China, and colleagues wrote. Current pharmacotherapies relieve COPD symptoms and improve exercise tolerance, but have not proven effective for relieving the airflow limitations caused by mucus accumulation that “leads to irreversible structural damage and an unfavorable prognosis,” the researchers said. Although reducing AMH could help manage COPD, the molecular mechanisms of action have not been fully explored. In a study published in Biomedicine & Pharmacotherapy , the researchers examined the relationship between IL-6 and AMH. Since IL-6 has been shown to cause overexpression of the mucin-type protein known as Muc5ac, they hypothesized that IL-6 antibodies (IL-6Ab) might block this protein elevation. The researchers recruited 30 adults with COPD and 30 controls from a single center. Bronchial epithelial cells were isolated from the participants and measured the levels of Muc5ac protein and mRNA in the lung tissue. Compared with controls, COPD patients had elevated Muc5ac positively correlated with IL-6. The researchers then created an organoid model of a trachea for COPD patients and controls. In the model, Muc5ac was similarly elevated in COPD patients, compared with controls. “Furthermore, IL-6 significantly induced excessive secretion of mucus in the organoid model of trachea in COPD patients as observed under electron microscope, and IL-6Ab attenuated these effects,” they noted. IL-6 significantly increased both Muc5ac mRNA and protein expression in the organoid model of trachea (P < .0001 and P < .005, respectively), but both of these significantly decreased when treated with IL-6Ab (P < .0001 and P < .05, respectively). The researchers also examined human and mouse cells to explore the mechanism of action of IL-6Ab. Using high-throughput sequencing, they found that the IL-6Ab induced nuclear translocation of the Nrt2 gene in COPD patients, and that this action promoted the effect of IL-6Ab on excessive mucus secretion. The study findings were limited by the relatively small study population from a single center, the researchers noted.

Race-Based Spirometry May Lead to Missed Diagnoses

JUNE 30 2022

It may be time to move beyond relying largely on spirometry to distinguish between healthy and abnormal lung function in diverse populations. That conclusion comes from investigators who looked at patients with ostensibly normal spirometry values in a large population-based study and found that using standard equations to adjust for racial differences in lung-function measures appeared to miss emphysema in a significant proportion of Black patients. "Our traditional measures of lung health based on spirometry may be underrecognizing impaired respiratory health in Black adults, and particularly Black men," said lead author Gabrielle Liu, MD, a fellow in the division of pulmonary and critical care medicine at the Northwestern University Feinberg School of Medicine in Chicago. "CT imaging may be useful in the evaluation of those with suspected impaired respiratory health and normal spirometry," she said in an oral abstract session at the American Thoracic Society International Conference 2022. Liu and colleagues studied the association between self-identified race and visually identified emphysema among 2674 participants in the Coronary Artery Risk Development in Young Adults (CARDIA) study. The patients had CT scans at a mean age of 50, and spirometry at a mean age of 55. Investigators found that among men with forced expiratory volume in 1 second (FEV1­) ranging from 100% to 120% of predicted according to race-adjusted formulas, 14.6% of Black men had emphysema, compared with only 1.7% of White men (P < .001). Respective emphysema rates in Black women and White women were 3.8% and 1.9%; this difference was not statistically significant. Among patients with FEV­1 80% to 99% of predicted according to race-specific measures, 15.5% of Black men had emphysema, compared with 4% of White men (P < .001). Respective rates of emphysema were 6.9% for Black women vs. 3.2% for White women (P = .025). When the investigators applied race-neutral spirometry reference equations to the same population, they found that it attenuated but did not completely eliminate the racial disparity in emphysema prevalence among patients with FEV1 ranging from 80% to 120% of predicted.

Companies Establish a Canadian Distribution Agreement

JUNE 29 2022

Breas Medical USA and McArthur Medical Sales announced a Canadian distribution partnership for the Breas Medical’s Vivo 1-2-3 family of Bi-level devices and a full line of Breas Vivo accessories. The Vivo 1-2-3 product family are bi-level ventilators designed for comfortable respiratory support across the continuum of care, both non-invasive and invasive (Vivo 3 only), for non-dependent patients with chronic breathing insufficiency. Featuring a built-in humidifier with heated wire circuit, a comprehensive set of modes with Auto-EPAP and High Flow Nasal Cannula therapy support plus SpO2 monitoring. “Breas is thrilled to partner with McArthur Medical Sales to bring Vivo technology to the Canadian marketplace. We could not imagine working with a stronger, trusted, and successful partner to support Canadian clinicians and patients with Breas Vivo technology,” said Chris Southerland, General Manager, Breas Americas. McArthur Medical is pleased to be partnering with Breas Medical and providing their innovative technology to support patient needs across the country. “The Vivo product family is going to allow for significant clinical advancement in bi-level therapy; our highly skilled team of clinicians are looking forward to introducing Vivo to the Canadian healthcare system. The Breas line of products will enhance patient outcomes,” said Frank Fiorenza, Product Development and National Sales Manager, McArthur Medical Sales.

Monaghan Medical and Children’s Hospital Association join forces to improve patient outcomes

JUNE 28 2022

Monaghan Medical Corporation (Monaghan) and Children’s Hospital Association (CHA) announced their agreement to a three-year contract creating a partnership between two industry leaders. The agreement recognizes the value of Monaghan’s patient outcome evidence and gold standard medical devices, with CHA’s desire to drive process efficiencies and value driven healthcare spending. The agreement will see Monaghan provide CHA members with devices in two categories: Respiratory Therapy Medication Delivery devices and Oscillatory Positive Expiratory Pressure/Positive Airway Pressure devices. Signing both categories’ agreements together at once recognizes Monaghan’s reputation for both industry leading technology and proven clinical outcomes. Monaghan is a US-based manufacturer based in Plattsburgh, New York. Monaghan and its affiliates are leaders in the development and manufacture of medical devices that improve the quality of life of patients with respiratory diseases like asthma, Cystic Fibrosis, and COPD. Monaghan’s strength lies in product development and mechanical design supported by a world-class Aerosol and Research Laboratory. As the national voice of more than 220 children's hospitals, CHA is advancing child health through innovation in the quality, cost, and delivery of care in children’s hospitals and health systems. Children’s hospitals are essential providers, setting the standard for the highest quality pediatric care while training the next generation of pediatricians. Alongside their members, CHA champions policies, practices and performance improvements that enable children’s hospitals to better serve children and families. “CHA is leading the way in rethinking how Children’s Hospitals evaluate cost-effective supply chain decisions. They recognize that cost savings fully materialize when staff efficiencies, inventory consolidation, and patient outcomes all improve. In addition to our proven outcomes and hundreds of clinical studies, the fact that Monaghan’s supply chain is primarily based in the United States and Canada also built confidence in our ability to respond to the rapidly changing healthcare environment,” says Bill Seitz, Vice President of Sales and Marketing for Monaghan Medical. During the COVID-19 pandemic, Monaghan was able to respond quickly to fluctuating market demands, primarily because their suppliers are within driving distance from their production facility, which meant a quick response to the changing healthcare needs.

Telesair Secures Strategic OUS License Agreement for NextGen Respiratory Tech

JUNE 28 2022

Telesair, Inc., an innovator of next generation respiratory care, announced that it has closed a license agreement with a leading global medical device manufacturer. Per the agreement, Telesair will utilize its patented technologies to develop a new respiratory platform for use initially only in an outside the United States (OUS) geography. In exchange, Telesair will earn a multi-million dollar upfront payment, a multi-million dollar milestone upon completion of its offering, and ongoing royalty payments based on sales of the device. “This partnership represents validation of Telesair’s technical capabilities to produce advanced respiratory technologies not currently on the market today,” said Telesair CEO, Bryan Liu. “Telesair management’s ability to identify unmet needs in the market and develop technology to address those needs will create a continuum of respiratory care that extends from better managing patients in the hospital through facilitating an earlier transfer of patients to lower cost settings such as the home. We have one of the best R&D teams in the space, and with our technological innovations, we will continue to develop our own pipeline of proprietary solutions to address a wide array of diseases in the multi-billion dollar global respiratory market.”

Best Practices Award Honors Commitment to Neonatal/Respiratory Care

JUNE 21 2022

Dräger, an international leader in the fields of medical and safety technology, announced that Frost & Sullivan has selected the company for its 2022 Global New Product Innovation Leadership Award in the categories of neonatal and respiratory care. Dräger was the recipient of Frost & Sullivan’s Global Technology Innovation Leadership Award for mechanical ventilation in 2014, 2017, and 2020, which are consecutive evaluation periods in this specific category. It remains unmatched in achieving this level of recognition as a single company during this time-period. Frost & Sullivan’s award criteria evaluate companies on their devices and the overall value they deliver to healthcare. Reflective of this year’s award, Dräger’s approach goes beyond its extensive expertise and best-in-class capabilities, with customer value as a strategic imperative. “Healthcare executives are looking for value beyond devices to support care delivery in the NICU and critical care environments,” said President and CEO for Draeger, Inc., Lothar Thielen. “This award validates our approach of combining best-in-class products, cost-effective accessories, and service solutions that deliver unmatched value for our hospital customers.” Frost & Sullivan applauded Dräger’s focus on improving outcomes for a baby’s neonatal intensive care unit (NICU) stay, highlighting the NICU by Dräger concept, which is designed to achieve this goal. Through this single, comprehensive solution, Dräger supports clinicians in delivering flexible, family-oriented, and patient-centric care, providing best-in-class neonatal ventilation and lung protection solutions, thermoregulation, jaundice phototherapy devices, and neonatal care accessories, along with expert NICU design and workflow consultancy. “Dräger’s new and purpose-built solution suite for neonatal care sets it apart from its competitors, with superior design, reliability, and quality as its central pillars,” the award text reads. In its research, Frost & Sullivan noted a key differentiator for the company; its commitment to supporting customers’ paths toward clinical needs, “Unlike competitors, Dräger builds its products by collaborating closely with a range of stakeholders and partners to evolve alongside market needs and trends. It works with leading physicians leveraging its advisory board, product managers, and research and development team to interact with key opinion leaders around the globe to understand the actual customer and market demands.” The award also honors Dräger’s commitment to continuing education. Dräger’s “A Breath Ahead” portal provides clinicians access to live and online continuing respiratory care education (CRCE) courses. Through its INSIGHTS program, Dräger shares ideas and innovations that can help hospitals achieve their goals by improving clinical outcomes, managing the cost of care, ensuring staff satisfaction, and enhancing the patient experience. “Dräger maximizes patient outcomes by improving safety, increasing the education level for clinicians, streamlining supply chain issues, and creating cost-effective and reliable biomedical solutions,” said Bhaskar Vittal, industry principal for Frost & Sullivan. “Everything that makes a healthier hospital in terms of patients’ safety, costs and outcomes for customers are the reasons driving Dräger’s successful momentum and continuous development over decades.”

First Woman Pulmonary Chief at UM, Author to Share Perspective

JUNE 17 2022

Vitalograph, a manufacturer and supplier of high-quality spirometers and respiratory medical devices which aid detection, diagnosis, and control of respiratory conditions, is pleased to host a timely and important lunch and learn webinar on lung health with renowned lung expert and author, MeiLan Han, MD, Chief of Pulmonary and Critical Care at the University of Michigan and author of the book, Breathing Lessons available on Amazon. Dr Han will be presenting to healthcare professionals a “Lunch and Learn Webinar” sponsored by Vitalograph on July 6th, 2022, at 12:00 CST. Her topic will be Breathing Lessons A Doctors Guide to Lung Health and will feature insights from her book of the same name. This presentation will be an American Association for Respiratory Care (AARC) and Continuing Respiratory Care Education (CRCE) credited program.

To register for the free webinar,

“We are thrilled to have Dr Han with us for this important webinar that will provide insights on lung health that many Americans haven’t considered - many that weren’t well known until the COVID respiratory crisis began,” said Mark Russell, Marketing Communications Manager for Vitalograph. “Dr Han has been in the trenches of the pandemic, as a critical care physician, as well as a female leader. She has seen the struggles patients and families have gone through and has seen the impact on healthcare professionals.” Dr Han was named Distinguished Achievement Awardee by the American Thoracic Society (ATS) during its first in-person international conference in three years. The award recognizes individuals who have made major contributions that advance the mission of the American Thoracic Society. Awardees like Dr Han have made substantial contributions to prevention, diagnosis and treatment of lung disease, critical illness, or sleep disorders through advocacy, training, and mentorship. The award recognizes one major accomplishment or cumulative impact on the field. With her book, Breathing Lessons, Dr Han hopes to help improve the public’s understanding of lungs and how they work so they can protect themselves now and prepare for the next pandemic or other respiratory threat. Her writings go beyond her book and her published research. She also published an op-ed in the Los Angeles Times in January drawing much-needed attention to the deadliest and least talked about part of the pandemic – lung failure. She has spoken with media nationwide on the topic trying to gain government attention to the leading cause of death in America and that lung damage, scarring and failure have been the cause of a million deaths so far in the pandemic. In the early days of the pandemic, Dr Han saw firsthand how little most patients understood about the lungs, breathing, and emergency breathing tools including non-invasive breathing support and ventilators. While people with existing lung diseases may be familiar with pulse oximetry and spirometry, most Americans had never heard of them prior to the pandemic crisis. So, she wrote her book, Breathing Lessons, as a reference to make it easy for any and all audiences to understand important information about their lungs, the tools that are used to diagnose, treat and support them, and how to keep their lungs healthy. It also provides detailed information on most chronic and deadly lung diseases. Dr. Han hopes all medical professionals will recommend the book for their patients. It is available on Amazon as well as through other booksellers. MeiLan Han, MD, MS was named the first female Chief of Pulmonary and Critical Care in the University of Michigan’s history and one of few female chiefs of critical care in the nation. She is also a Professor of Medicine and Chief of the Division of Pulmonary and Critical Care at the University of Michigan. She received her medical degree from the University of Washington in Seattle, WA. She completed her residency in Internal Medicine and fellowship in Pulmonary and Critical Care Medicine at the University of Michigan. Dr Han has also completed a Master's Degree program in Biostatistics and Clinical Study Design at the University of Michigan School of Public Health. Dr Han’s research has focused on defining phenotypes in COPD using imaging. She is a lead investigator for several NIH sponsored COPD studies. She also serves on the scientific advisory committees for both the COPD Foundation and American Lung Association, the board for the COPD Foundation and serves as a spokesperson for the American Lung Association. She is currently a Deputy Editor for the American Journal of Respiratory and Critical Care Medicine and serves on the editorial boards for Thorax, Lancet Respiratory Medicine and Journal of the COPD Foundation. She is also a member of the Global Obstructive Lung Disease scientific committee which is charged with developing internationally an internationally recognized consensus statement on COPD diagnosis and management.

Study Demonstrates Utility of MediPines AGM100 in Triaging COVID-19 Patients

JUNE 17 2022

In a study presented at the American Thoracic Society (ATS) International Conference 2022, the MediPines AGM100 was shown to provide data that helped identify patients who are at risk of respiratory failure and in need of escalated care due to COVID-19. The measurement of gas exchange impairment (known as Oxygen Deficit) helped physicians accurately determine the need for hospital admission and supplemental oxygen administration in the emergency department (ED). The ongoing study, titled “Use of the Alveolar Gas Meter for Point-of-Care Triage in COVID-19 Patients” was authored by a team of practicing ER physicians and scientists from the University of California San Diego (UCSD Health) and demonstrated the utility of non-invasive gas exchange analysis (AGM100) on patients who reported to the ED with symptoms of COVID-19. The data indicate that the AGM100 is useful for important hospital admission and supplemental oxygen administration decisions in COVID-19 patients. Additionally, the authors found that the AGM100 is able to identify patients at risk prior to obvious clinical deterioration, in a non-invasive, point-of-care fashion. Many high-risk patients, especially those infected with COVID, currently go unidentified due to the limitations of existing measurements available to physicians in the ED. Frequently, stand-alone oxygen saturation is utilized to make triage decisions, but the current study reinforced the notion that stand-alone oxygen saturation (≥92%) measurements failed to identify almost half of the patients who later required supplemental oxygen. This can lead to delayed treatment and devastating consequences for patients who are in immediate need of escalated care. By contrast, elevated Oxygen Deficit (>40 mmHg) was shown to be highly sensitive and specific in determining supplemental oxygen needs (ROC curve AUC: 0.97). Additionally, an elevated Oxygen Deficit (>30 mmHg) was effective in predicting the need for hospital admission (ROC curve AUC: 0.78). The MediPines gas exchange technology represents the only non-invasive, real-time method of obtaining Oxygen Deficit measurements, uniquely positioning it to provide significant clinical benefit for patients with (or at risk for) COVID-19 and other cardiopulmonary complications. “Oxygen Deficit is the most convenient and informative measure of impaired lung function (gas exchange) caused by disease process like COPD or sudden serious respiratory infection of lung parenchyma as in COVID,” stated study co-author and leading global authority on respiratory physiology, John B. West, MD, PhD. The MediPines AGM100 is an FDA-cleared, advanced pulmonary gas exchange technology that provides Oxygen Deficit, a surrogate for the alveolar to arterial oxygen difference (AaDO2), as well as gPaO2, PETCO2, and other sensitive measurements of pulmonary gas exchange. Designated by the World Health Organization (WHO) as an innovative and commercially available health technology for global priority diseases in its 2021 edition of the WHO Compendium of Innovative Health Technologies, the MediPines AGM100 is a portable system that is being used in emergency departments and throughout the continuum of care in hospitals. “Clinicians are asking for better methods to triage COVID-19 patients, especially as they recognize that COVID will likely become an endemic problem into the future,” said MediPines CEO, Steve Lee. “This study demonstrates that the AGM100 has utility for physicians on the front lines of medicine to combat the rising chronic respiratory disease burden.”

New Endotracheal Tube Holder Released

JUN 2 2022

Dale Medical Products, Inc., the employee-owned company known for its high-quality, patient-friendly medical device securement solutions, is expanding its offering with its new BreezeLock Endotracheal Tube Holder. Like the Dale Stabilock Endotracheal Tube Holder, the new endotracheal tube holder features a soft, comfortable, flexible neckband with no hard plastic parts. The BreezeLock includes a Tube Track for easy repositioning of the endotracheal tube while still allowing easy access to the mouth for oral care. “Clinicians tell us they appreciate the improved ease of repositioning with the Tube Track and the security of Dale BreezeLock,” says Robert Simpson, President of Dale. “We are pleased to expand the offering with our new endotracheal tube holder to help clinicians provide optimal care for their patients.” For more information about Dale’s new BreezeLock Endotracheal Tube Holder, or to request a product sample, visit or call 800-343-3980.

MGC Diagnostics Signs Global Distribution Agreement

MAY 31 2022

MGC Diagnostics, a global medical technology company dedicated to cardiorespiratory health solutions and products focused on physician offices, laboratories, hospitals, and universities has partnered with UK med-tech company, Bedfont Scientific Ltd., a world leader in breath analysis, whose portfolio includes the NObreath fractional exhaled nitric oxide test monitor for use in the hospital or at remote locations. Branded the FeNObreath, MGC Diagnostics will leverage its cardiopulmonary products and diagnostic device experience by providing Fractional Exhaled Nitric Oxide (FeNO) testing to measure airway inflammation for the management and aid in diagnosis of conditions such as asthma. “We are proud that our partnership with Bedfont Scientific, Ltd. gives our customers access to proven and validated FeNO technology. Bedfont gives us the opportunity to bring a great product to our markets and to provide a simple and affordable solution to those looking for a FeNO monitor,” said Ralph Cook, Vice President of Global Marketing and Product Management of MGC Diagnostics. The FeNObreath works by measuring FeNO through breath analysis, making the process quick, simple, and non-invasive for both the Healthcare Professional and the patient. Interpreting FeNO levels aids in identifying patients who do/do not require ongoing treatment while also differentiating between allergic (eosinophilic) and non-allergic asthma, and if used daily, FeNO measurements can help to predict and prevent exacerbations and attacks. “We’re excited to be working with MGC Diagnostics,” said Jason Smith, Managing Director at Bedfont Scientific Ltd. “We are very impressed with their strong foothold in the respiratory market, their preceding reputation for product quality and customer support, and their commitment and enthusiasm to improving respiratory care. MGC Diagnostics is the perfect distribution partner to help us realise our goal of making FeNO monitoring more accessible globally.”

MediPines Technology Now Being Used to Help Detect Pulmonary Embolism

MAY 24 2022

An increasing number of physicians have been utilizing a unique gas exchange analyzer technology to enhance recognition and diagnosis of pulmonary embolism (PE) in patients. The device, called the MediPines AGM100, is an FDA-cleared advanced pulmonary gas exchange technology that can precisely and non-invasively measure patients’ oxygen and carbon dioxide levels in the deepest part of the lungs (alveoli), as well as oxygen deficit (alveolar-arterial difference), which support assessment of respiratory impairment. A case study titled “Use of a Non-Invasive Pulmonary Gas-Exchange Analyzer to Improve the Pretest Probability of Pulmonary Embolism in a Patient Classified as ‘Low Risk’” by Dylan Sieck Ph.D. and Pierre Ozon, MD was presented at the American Thoracic Society (ATS) International Conference last year. Since then,  more and more clinicians and centers of excellence have been turning to the MediPines AGM100 as a diagnostic support tool to enhance recognition of PE. PE is one of the leading causes of death in the US and the third leading cause of death in hospitalized patients. Given the possibility of asymptomatic and atypical presentation, it is generally accepted that many cases of PE go undiagnosed. In the case study presented at ATS last year, the MediPines AGM100 device, a cardiopulmonary diagnostic support system, was shown to be a helpful adjunct tool in the diagnosis of PE and ideally suited to the task because of the quick and precise measurements it provides. The patient described in the case study was the first reported case of a non-invasive pulmonary gas-exchange analysis being used to improve pre-test probability of PE. Since then, more physicians have been turning to the technology as a diagnostic tool. “Having an objective measure of pulmonary gas exchange impairment can factor into the diagnosis and treatment decisions that must be made in a time sensitive manner,” said Dr Pirre Ozon, an Emergency Physician, and one of the case study’s authors. “The AGM100’s multiple measurements including oxygen deficit measurement can be highly informative in narrowing differential diagnosis scenarios similar to this case and more research is needed to fully understand its potential.” Designated by the World Health Organization (WHO) as one of 15 notably innovative and commercially available health technologies for the treatment of COVID-19 and other global priority diseases in its 2021 edition of the WHO Compendium of Innovative Health Technologies, the MediPines AGM100 is a portable system that can be used throughout hospitals or qualified health clinics.

Company Celebrates 21 Years of Clinical Trials

MAY 23 2022

Vitalograph is celebrating 21 years of empowering respiratory research through clinical trials services, building on its legacy of manufacturing respiratory diagnostic devices since 1963. Team members from the UK, USA and Ireland will be marking this milestone by fundraising for local respiratory charities in support of Vitalograph’s commitment to improve patient lives. “We are hugely proud of our team’s dedication and innovation to drive quality across the growing range of services whilst maintaining a focus on sponsor and protocol-specific requirements. I am delighted that this is evidenced by excellent quality outcomes, returning customers and positive site feedback. Our ongoing mission is to improve patient lives through the delivery of clinical trial respiratory endpoints for the world’s leading pharmaceutical companies,” said Richard James, Clinical Trials Director. Vitalograph’s Clinical Trials division offers expert clinical, project, and data management services along with their innovative device solutions, delivered by experienced teams who are known for their friendly, customer-centric approach. Vitalograph specialises in electronic data capture of physiological respiratory measures and eCOA, along with further endpoints commonly used in respiratory studies such as blood pressure and ECG. Through strategic investment in research and development of respiratory diagnostic products, Vitalograph offers ground-breaking data collection systems for clinical trials. Two such systems are VitaloJAK, a validated cough monitoring system for measuring objective cough frequency in commercial clinical trials, and In2itive e-Diary for collecting home ePRO and physiological respiratory measurements. As it looks to the future, Vitalograph is committed to continuing to deliver expert study services and to design unique respiratory diagnostic solutions that are validated, accurate and tailored to meet the needs of each clinical trial.

Inhaled Corticosteroid Shows Significant Impact

MAY 16 2022

Full results from the positive MANDALA Phase III trial showed that PT027 (albuterol/budesonide) at two different strengths of budesonide, an inhaled corticosteroid (ICS), used as an as-needed rescue medicine, demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma. PT027 is a potential first-in-class inhaled, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide in the US. It is being developed by AstraZeneca and Avillion. Globally, more than 176 million asthma attacks are experienced each year. Compared with albuterol rescue, PT027 at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p<0.001) in adults and adolescents.1,2 In the trial, patients were randomized to receive PT027 or albuterol rescue, on top of their usually prescribed maintenance ICS, with or without additional controller medicines. In secondary endpoints, PT027 (180mcg albuterol/160mcg budesonide) demonstrated a 33% reduction in mean annualized total systemic corticosteroid exposure (p=0.002) and a 24% reduction in annualized severe exacerbation rate (p=0.008).1,2 A numerically higher odds of patients experiencing an improvement in symptom control and quality of life was also observed after 24 weeks of treatment with PT027 compared to albuterol rescue. Adverse events (AEs) were similar across the treatment groups in the trial and consistent with the known safety profiles of the individual components, with the most common AEs including nasopharyngitis and headache. Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: “The MANDALA Phase III trial results demonstrated that PT027, a novel fixed-dose combination of albuterol/budesonide used as-needed, provided additional anti-inflammatory treatment in response to patient symptoms, which led to a reduced risk of severe exacerbations compared with albuterol alone. These data further strengthen the growing body of evidence around the value of as-needed anti-inflammatory treatment in asthma and support PT027’s potential to transform the current rescue treatment approach.” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Asthma is an inflammatory, variable disease and patients are at risk of experiencing a severe exacerbation regardless of disease severity and adherence to treatment. The results from these Phase III trials support the clinical benefit of PT027, an albuterol/budesonide rescue inhaler, which has the potential to be a first-in-class treatment approach that can prevent asthma attacks over and above their current maintenance therapies.” In the MANDALA trial, PT027 at a lower budesonide dose (180mcg albuterol/80mcg budesonide), also demonstrated a statistically significant reduction of 17% in the risk of severe exacerbation versus albuterol rescue (p=0.041), when used as an as-needed rescue medicine in adults, adolescents, and children aged 4–11 years. The results were published in the New England Journal of Medicine and will be presented at the American Thoracic Society (ATS) 2022 International Conference.

Study Shows Effectiveness in Treating Asthmas

MAY 16 2022

A greater proportion of patients with severe, uncontrolled asthma had more significant clinical responses to tezepelumab than placebo, according to research published at the ATS 2022 international conference. The study showed that nearly half of those enrolled achieved complete response to treatment across measures of exacerbation reduction, asthma control, lung function, and clinician assessment. The study is a prespecified on-treatment analysis of responses to tezepelumab using data from the completed phase 3, double-blind, placebo-controlled NAVIGATOR trial (NCT03347279). Results of the trial were presented at ATS 2021 and published in a peer-reviewed medical journal. “Overall, these results align with the NAVIGATOR results reported at ATS 2021 and add an important patient-level perspective to the primary study results,” said presenting author Njira Lugogo, MD, associate professor of internal medicine as well as medical director, Michigan Clinical Research Unit and director, Asthma Program, Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor. “Across each measure, tezepelumab recipients were more likely to have a response; the greatest difference observed was for exacerbation reduction. In addition, 48 percent of patients receiving tezepelumab had a complete response and achieved significant and clinically relevant improvements in all four response measures.” Both the tezepelumab and placebo patients continued to take their medium- or high-dose corticosteroid inhalers and at least one other asthma-control medication during the study. Four-hundred seventy-one patients receiving tezepelumab and 449 receiving placebo completed the on-treatment period and were included in the analysis. Across response criteria, the proportion of responders was higher in the tezepelumab than in the placebo group for exacerbation reduction (85.4 percent vs. 67.5 percent); Asthma Control Questionnaire (ACQ)-6 total score (86.9 percent vs. 76.6 percent); an improvement from baseline pre-bronchodilator forced expiratory volume in one second (FEV1) (60.3 percent vs. 49.9 percent); and in Clinical Global Impression of Change (CGI-C) score (81.5 percent vs. 67.7 percent). The proportion of complete responders (those who achieved significant improvement on all measures) was higher in the tezepelumab group that in the placebo cohort (48.2 percent vs. 25.3 percent). Tezepelumab is a biologic—a medical treatment made from living cells. Dr Lugogo stated, “Responses to biologics in asthma are heterogenous and the impact of biologics on key asthma outcomes can vary between patients. We were interested in determining the impact of tezepelumab on the four clinical outcomes of most interest, which included exacerbation reduction, improvement in symptoms and lung function, and the treating clinician’s impression of whether clinical improvement had occurred. There is increased interest in defining responses in patients with severe asthma on biologics. In this study, we identified both responses in each measure and combined responses overall.” She also noted that these results can be used in shared decision making when discussing the start of tezepelumab therapy. “Patients are always interested in understanding the potential outcomes following therapy initiation and our results can guide clinicians in informing patients about the likelihood of both individual and complete response to therapy.” This study was supported by AstraZeneca and AMGEN. Dr Lugogo has served on advisory boards for AstraZeneca and AMGEN and as a consultant for AstraZeneca. She has given talks sponsored by AstraZeneca, using her own content.

Stationary Oxygen Concentrators Launching in Latin America

MAY 5 2022

Global oxygen equipment manufacturer CAIRE Inc. is expanding its portfolio of solutions in Latin America. The Companion 5 and NewLife Intensity 10 stationary oxygen concentrators are expected to launch in July, following an anticipated approval by the Brazilian Health Regularity Agency (Anvisa). “During the past two years, the COVID-19 pandemic oxygen shortages throughout South America have underscored the need to expand CAIRE’s portfolio of equipment available to providers to serve patients prescribed oxygen as they are discharged from the hospital,” said Barry Hassett, Vice President of Global of Marketing. Currently CAIRE products available in Brazil include the award-winning FreeStyle Comfort portable oxygen concentrator, the clinically-proven Eclipse 5 transportable oxygen concentrator, and liquid oxygen (LOX) systems including the Stroller portable and Liberator reservoir. The FreeStyle Comfort and Eclipse 5 can produce unlimited oxygen drawing in ambient air, filtering it, and delivering up to 95 percent pure oxygen to the user via nasal cannula. Both medical devices are designed for oxygen users during activity and travel, and are powered by battery or electrical power. Both come equipped with CAIRE’s proprietary, smart O2 delivery technologies, including autoSAT that ensures the user receives the oxygen they need with every breath. LOX systems require regular refills from a gas provider, but are an excellent solution for oxygen users who require high flow prescriptions. Users stay mobile with a lightweight portable, while reservoirs support their needs for at-home use. The addition of the two stationary oxygen concentrators (SOCs) is a major step in providing distributors with equipment for their patients’ at-home oxygen needs using the full breadth of CAIRE’s industry-leading portfolio. SOCs offer the oxygen user the ability to receive continuous flow oxygen as they move about their home, engaging in daily living activities. The Companion 5 is a 5 liters per minute (LPM) concentrator offering a small footprint and energy efficiency for the user. Global medical equipment providers frequently supply this concentrator to the respiratory patient along with the FreeStyle Comfort as a complete non-delivery solution for both active and at home oxygen needs. The rugged, time-proven NewLife Intensity 10 has been a long-time trusted, go-to device, supporting specialty applications in more than 100 countries. It offers up to 10 LPM and an output of 20 PSI. It is often paired with CAIRE’s SureFlow oxygen system, allowing healthcare workers to deliver oxygen up to five patients simultaneously in clinical settings.

New Partnership Announced on Health Monitoring

APR 29 2022

VitalFlo announced that it has partnered with Vitalograph to provide smart respiratory health monitoring through Vitalograph’s range of remote monitoring spirometry devices. This partnership enables patients to perform reliable lung function tests anytime, anywhere as a critical element in the ongoing management of their respiratory health. “For us, the key characteristics we look for in spirometry devices are accuracy, ease of use, and affordability,” said Luke Marshall, CEO of VitalFlo. “With nearly 60 years experience, Vitalograph is a great fit for us as we strive to bring lung function testing and monitoring to the patient.” Using VitalFlo’s innovative digital healthcare platform, Vitalograph’s range of remote monitoring solutions enable clinical teams to provide proactive and routine management of respiratory diseases and conditions. This in turn improves the quality of life of those affected and empowers respiratory healthcare professionals to perform their job to the best of their abilities, and to better manage resources. Executive Vice President of Vitalograph’s Sales &amp; Operations for North America, Troy Pridgeon added: “This is a very exciting opportunity to work with VItalFlo because they see healthcare as a connected whole. A digitally transformed space helping patients and healthcare workers to manage and prevent illness more quickly, conveniently, and seamlessly. Vitalograph is proud to include our devices for respiratory monitoring into this impressive digital healthcare system.”

Vitalograph and the Asthma and Allergy Foundation of America Host Webminar on Patient Experiences with Inhaler Usage

APR 26 2022

Vitalograph is delighted to announce this year’s first lunch and learn webinar series with the collaboration with the Asthma and Allergy Foundation of America. The topic is “PATIENT EXPERIENCE: INHALER USAGE,” and it will address common challenges related to inhaler usage and strategies for effective patient education on inhaler adherence and technique. The webinar will be held on Wednesday May 11th, 2022, at 12:00 pm (CST). May is National Asthma and Allergy Awareness Month. It is a peak season for people with asthma and allergies, and a perfect time to educate patients, health care providers, and others about these diseases.
Featured Speaker: Melanie Carver, Chief Mission Officer, Asthma and Allergy Foundation of America (AAFA)
These are the goals of the webinar:

  • Understand patient and caregiver experience with inhaler usage
  • Learn about common challenges and barriers for patients and healthcare providers to overcome
  • Develop strategies for effective patient education on inhaler adherence and technique

You can register at:;source_id=9cab7a60-e2ee-4082-902d-812a402577d0

AARC CRCE Accreditation: The Continuing Respiratory Care Education (CRCE) system approves and accredits educational programs, assuring their value to your continuing education needs. A sponsor of continuing education courses will use the resources in this area.

Neotech Launches NeoGlo Disposable

APR 26 2022

Neotech has introduced a neonatal transilluminator developed specifically for single patient use: NeoGlo Disposable! NeoGlo Disposable is available with red or white LED lights. It is light weight, compact, and features a USB power connector. No batteries required. “Infection in general, and especially cross contamination, is a great concern in the NICU. I approached Neotech to develop a small, inexpensive neonatal transilluminator that could be used for one patient and then discarded when the patient is sent home,” Professor Ruben Bromiker, Neonatologist said. “I’m thrilled to see this product come to fruition. Having one transilluminator per patient will also make it more available, thus encouraging the staff to use it. And studies show that the use of transillumination improves the chances of success; reducing the number of pricks we give a patient.” After the successful launch of the original NeoGlo, Neotech set out to deliver Dr Bromiker’s original, hospital-driven concept. “Dr Bromiker came to us with a fairly simple idea: an affordably-priced device that could be plugged into a USB power source,” Sara Dimmitt, Manager of New Product Development said. “It was focused on the needs of the international market. After some market research in the U.S., his idea evolved into a reusable neonatal transilluminator with multiple light settings. But we always intended on revisiting a disposable option. And with Philips discontinuing their Wee-Sight®, it’s perfect time to introduce NeoGlo Disposable to the market.” Now, Neotech offers two great transillumination options. The original reusable and the new NeoGlo Disposable.

Masimo SedLine Brain Function Monitoring Reduced the Use of Anesthetic Agents and Opioids

APR 25 2022

Masimo announced the findings of a retrospective study published in the Journal of Cardiothoracic and Vascular Anesthesia in which Dr André Denault and colleagues at the Montreal Heart Institute and Centre Hospitalier de l’Université de Montréal investigated the impact of anesthesia during cardiac surgery guided by Masimo SedLine Brain Function Monitoring, in particular by SedLine’s processed electroencephalography (pEEG) feature, the Patient State Index (PSi). This study is the first to primarily explore the impact of pEEG-guided anesthesia on vasoactive and inotropic drugs—drugs that affect the diameter of blood vessels and that modify the force of the heart’s contractions, respectively—in the ICU. The researchers found that pEEG-guided anesthesia was associated with a reduction in the use of such drugs, as well as less use of anesthetic agents and opioids in the OR, lower central venous pressure (CVP), less fluid administration, less intraoperative bleeding, and shorter duration on mechanical ventilation. Noting that pEEG-guided anesthesia may improve hemodynamic stability and that high postoperative doses of vasoactive and inotropic drugs have been associated with mortality and renal dysfunction, the researchers sought to determine whether use of pEEG-guided anesthesia might improve outcomes by reducing use of such agents during cardiac surgery and at arrival in the ICU. Their primary goal was to determine whether pEEG-guided anesthesia would be associated with reduced hemodynamic instability during cardiopulmonary bypass (CPB) separation, measured by stratifying the operation into three categories: “easy” (use of only one vasoactive or one inotropic agent), “difficult” (use of at least two different classes of agents), or “complex” (requiring a return to CPB or use of mechanical circulatory support). Their secondary goal was to determine if pEEG-guided anesthesia would lead to the hypothesized reduction in vasoactive and inotropic drug administration in the ICU, measured by vasoactive and inotropic score (VIS). The researchers compiled a retrospective cohort of 300 adult patients who underwent cardiac surgery using CPB between 2013 and 2020 at the Montreal Heart Institute. The patients were divided into two groups, depending on whether anesthesia was guided by pEEG, which became a standard of care in 2017. Patients in the pEEG group (n=150) had their brain function monitored, from the moment they entered the OR to arrival in the ICU, using Masimo SedLine. In the pEEG group, patients received fewer vasoactive and inotropic drugs in the first hour after ICU admission, resulting in lower VIS scores (pEEG: 5 [0-10], control: 8 [2-15], p=0.003). Being in the pEEG group reduced the odds of being in a higher VIS category by 57% (OR=0.43; 95% confidence interval: 0.26-0.73; p=0.002). In addition, in the pEEG group, several additional outcomes were lower: duration of mechanical ventilation (pEEG: 3 hours [2-4 hours], control: 4 hours [3-7 hours], p<0.001), intraoperative fluid balance (pEEG: 758 mL [351-1329 mL], control: 500 mL [300-700 mL], p=0.002), and the amount of bleeding (pEEG: 400 mL [282-500 mL], control: 500 mL [300-700 mL], p=0.002). A lower proportion of patients experienced unsuccessful (difficult or complex) CPB separation in the pEEG group than the control group (60% vs. 72%, p=0.028). However, after adjusting for other parameters using multiple logistic regression, use of pEEG-guided anesthesia was not independently associated with successful CPB separation; instead, as the researchers note, unsuccessful separation was associated with several independent known predictors of hemodynamic complications. The researchers concluded, “pEEG-guided anesthesia is associated with a reduction in the use of inotropic or vasoactive drugs at arrival in the ICU. In addition, its implementation was associated with lower requirements of anesthetic agents and opioids in the OR, lower CVP, fluid requirements, intraoperative bleeding, and shorter duration of mechanical ventilation. However, its use did not facilitate weaning from CPB compared to a group where pEEG was unavailable. Future research is needed to confirm these results in prospective randomized clinical trials.”

User Centric Software Solution Now Available

APR 19 2022

PulManage, Inc announced that their user centric software solution is now available for remote spirometry and respiratory monitoring. The product was developed specifically to address issues surrounding diagnosis and management of chronic lung disease. The PulManage software uniquely connects and presents the signals from lung function data in conjunction with symptoms in real-time. This allows healthcare providers to monitor their patients between office visits and alleviates the burden of the patient calling the office to provide updates. The COPD population is underserved both for diagnosis and monitoring. CEO and founder Amanda Clark, RRT says, “PulManage fills a tremendous need in the market that has been spotlighted during the pandemic.” The use of spirometry to correctly identify lung disease is critical to maintain quality of life, effectively manage, and reduce the overall burden of COPD. Features: PulManage is a unique software platform that connects patients and providers. This multi-sided software includes a web portal for clinicians and a native mobile application paired with a bluetooth lung function device for patients. The system is quite distinctive and offers both remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) capabilities for clinicians. According to Dr. Charlie Strange, Chief Medical Officer, “Having this platform in the physician’s office is a way to let patients remotely monitor themselves while bringing in signals that providers can use to determine the right diagnosis and treat accordingly.” He continued his statement, “To do this in the patient’s home is an important way to bring technology into healthcare improvement.” The dual RPM and RTM functionality connects lung function data in conjunction with symptoms in real-time for a complete clinical assessment.

New Faces on Company’s Board

APR 5 2022

Nonin Medical announced the appointment of five new members to the company’s board of directors. The new directors bring a diverse and unique set of experiences, along with a passion for growth and innovation in the medical device and healthcare sectors. Together, they will provide Nonin with strategic guidance and support the company’s continued growth. The new board members are:

  • Waqaas Al-Siddiq, Founder and CEO of Biotricity
  • Larry Betterley, President and CEO of Lexington Advisors, LLC
  • Angela Dillow, Strategic Consultant and Board Director at Regions Hospital
  • Laura Gillund, Corporate Board Director and Global Human Resources Executive
  • Robert Rajalingam, President, U.S. Medical Products & Distribution, Cardinal Health

“We have assembled a team of world-class board members with successful track records in the industry who will provide valuable business insights as we accelerate our growth trajectory and serve customers across the globe. Looking to the future of Nonin, we are confident the new board members are uniquely qualified to support the next growth phase of the company,” stated Phil Isaacson, Executive Chairman, Chief Technology Officer and Founder, Nonin Medical. With healthcare technology playing a major role in the management of the global pandemic, the Nonin leadership team recognized the need for a new board of directors to help the company address rapidly changing market needs and meet the demands of providers, payors, and other audiences using health-driven digital and data solutions. Phil Isaacson will continue in his board role. The biographies of the new board are available at

Company Celebrates 20th Anniversary of Launch of the First Portable Oxygen Concentrator

APR 2 2022

Two decades ago, oxygen users all over the world had two therapeutic options for mobility — gas cylinders or a portable liquid oxygen device. Many lived life tethered to an at-home oxygen source, and were very limited in their ability to travel or maintain a healthy level of activity. That changed with the launch of the first portable oxygen concentrator, the LifeStyle — developed and marketed by CAIRE — dramatically improving the quality of life for oxygen users worldwide. “For us, pioneering the first portable oxygen concentrator has long been both a point of pride, and an ongoing incentive to continue to innovate and develop those technologies that will ensure clinically efficacious oxygen delivery and an improved quality of life for all of our users around the world,” said Earl Lawson, CEO of CAIRE Inc. Introduced under CAIRE’s AirSep brand, the LifeStyle portable oxygen concentrator, was the brainchild of then Vice President of Research and Development, Norman “Norm” McCombs, who modeled the size and weight of the device on his wife’s handbag which weighed in at 9.75 lbs. Harnessing specialized technology to separate the components of air, the portable oxygen concentrator operates by taking ambient air, filtering and compressing it and then delivering up to 95 percent purified oxygen to the user via a nasal cannula. Operational via battery, electrical, or motor vehicle power, the device allowed the user the convenience of taking their oxygen source anywhere, with the ability to plug-in and recharge extending their time away from home and encouraging them to live an active lifestyle with few restrictions. The LifeStyle would be the first POC to gain FAA approval for commercial air flights in 2005, paving the way for all POCs that would come after. McCombs was recognized for his contributions by US President Barack Obama in 2013 who presented him with the National Medal of Technology and Innovation at the White House. The award acknowledged McCombs’s development and commercialization of pressure swing adsorption oxygen-supply systems with a wide range of medical and commercial applications, leading to improved health, substantially reduced healthcare costs and positive impacts on the environment. The LIfeStyle paved the way for the FreeStyle series, and the world’s smallest portable oxygen concentrator, the Focus. These products lead the way in innovations in portable oxygen concentrators — lighter weight, expanded settings, clinical features — culminating in today’s FreeStyle Comfort. Introduced in 2018, this therapeutic medical device expands on the innovations of the past 20 years — recently outperforming six competitive devices in seven out of eight breathing scenarios through a COPD simulated protocol designed to assess the ability of these devices to effectively deliver oxygen to patients. Equipped with propriety, smart oxygen delivery technologies, the FreeStyle Comfort is designed to ensure effective oxygen delivery to best support long-term oxygen therapy patients maintain an active, healthy, and fulfilled lifestyle. UltraSense technology detects the pressure change in the nasal cannula as the patient takes a breath and ensures that the bolus, or puff of oxygen, is delivered in conjunction with the breath rate, and autoDOSE responsive technology delivers oxygen automatically even if no breath is detected. Additionally, the FreeStyle Comfort can wirelessly connect to the myCAIRE telehealth solution uniquely designed for medical equipment providers who want to enhance care for their oxygen users.

Benefits of Portable Oxygen Concentrator Confirmed in Study

MAR 30 2022

CAIRE’s premier portable oxygen concentrator, the FreeStyle Comfort, outperformed other market leading devices in a recent study designed to assess the effectiveness of these devices in delivering oxygen to patients. The study, “Comparison of portable oxygen concentrators using a COPD patient simulation model,” was conducted by Rachel Culbreth, PhD, MPH, RRT; Robert Murray, MS, RRT; Kyle Brandenberger, PhD; Douglas S. Gardenhire, EdD, RRT, RRT-NPS, FAARC with the Department of Respiratory Therapy, Byrdine F. Lewis College of Nursing and Health Professions at Georgia State University in Atlanta, GA. Researchers compared the oxygen output of eight competitive devices that currently comprise the majority of the portable oxygen therapy market, along with control group systems including a stationary oxygen concentrator and wall output oxygen similar to what a patient would receive in a clinical environment. Each device was assessed based on its ability to deliver oxygen in a variety of situations intended to model real-life use. In the US, it has been reported by the Annals of the American Thoracic Society that more than 1.5 million adults use supplemental oxygen for a variety of respiratory disorders. If prescribed and used properly, supplemental oxygen can improve the quality of life and prolong survival for these individuals. The GSU study demonstrated the CAIRE FreeStyle Comfort achieved higher FiO2 compared to all other POCs in seven out of the eight scenarios. FiO2 is defined as the percentage or concentration of oxygen a person inhales. Based on this information, the study concluded that clinical providers should account for their patients’ respiratory rate demands when recommending specific POCs. Presentations of the data were shared at the virtual 2021 Congresses hosted by the European Respiratory Society (ERS) and the American Association for Respiratory Care (AARC). GSU researchers will be publishing the accompanying white paper in a medical journal in the coming months. Introduced in 2018, the FreeStyle Comfort has earned recognition from its peers, and has been distributed to hundreds of thousands oxygen users globally. Offering smart oxygen delivery features, the FDA-cleared FreeStyle Comfort offers UltraSense sensitive breath detection, autoDOSE safety technology, and can be connected to the myCAIRE telehealth solution. Outside of the US, the FreeStyle Comfort offers the additional autoSAT technology which adjusts flow to keep pace with the user’s breath rate during rest or activity. “Portable oxygen concentrators are intended to allow patients to maintain a more active lifestyle despite the constraints which COPD or other respiratory conditions might introduce. The FreeStyle Comfort was specifically designed to optimize oxygen delivery in situations where the patient is not at rest in order to enable them to comfortably enjoy life outside the home,” said Barry Hassett, Vice President of Global Marketing. “This study confirms that the FreeStyle Comfort meets those objectives — ensuring patients get the oxygen they need when they need it.”

Neotech Turns 35

MAR 29 2022

Neotech Products LLC is excited to celebrate its 35th year developing and manufacturing innovative medical devices. Neotech Products is an essential brand in hospitals worldwide. Products include the RAM Cannula, Little Sucker suction tips, NeoShades Phototherapy Eye Shields, NeoBar ET Tube Holder, and more. Neotech made its mark as a neonatal company, but its reach extends beyond the NICU into pediatrics, children’s oncology, home healthcare, and more. They even offer products for adults, like EZCare trach ties and NeoSucker suction tips. “I think I am most proud of the impact we’ve made as a company over the last 35 years,” said Craig McCrary, Neotech President. “Impact to employees, impact to clinicians, and impact to patients and parents. “We’ve done things that have made a positive difference in many lives around the globe.” McCrary, who has been with Neotech for over 30 years, credits company success to: Simple, unique products; clinician-driven products that fill a need, and products made in the USA. “Made in the US has truly set us apart,” McCrary said. “Especially this past year when so many companies have experienced supply chain issues.” Neotech is a proud Certified B Corporation that continues to expand its international presence by developing simple solutions to medical needs. To learn more about Neotech and its products, please visit

Companies Partner for RT R&D

MAR 24 2022

Three leading companies in their respective fields - DFE Pharma (excipients solution provider), Harro Höfliger (equipment supplier), and Sterling (API manufacturer) — announced a unique partnership with the establishment of “Inhalation Together” (INTO) in the field of dry powder inhalation (DPI). This initiative provides R&D services to pharmaceutical companies in the respiratory field, making formulation development simpler, faster, and easier to manage. INTO offers a coordinated and aligned suite of services, leveraging the expertise and complementary skill sets of its three partners. Developing a DPI formulation is a complex process, with a strong interdependency between process, powder, device, and patient. This increases the need for high-quality customer support. To address the specific customer needs, the INTO services range from initial consultancy and problem statement development to a stepwise formulation development program. The individual services include, among others, solid-state characterization and sono-crystallization of APIs and studies to optimize formulation, blending, and filling. The three INTO partners can also offer extensive consultancy services.“I am very excited about the INTO initiative because it increases speed to market and reduces the complexity of formulation and process development. The three companies have a very good understanding of the critical aspects of development and manufacture of DPI products, therefore, adding significant value to our customers”, explained Martti Hedman, CEO of DFE Pharma.

Exhibitor Returns to American Thoracic Society’s International Conference

MAR 21 2022

ECO PHYSICS, INC. is once again going to be an exhibitor at the American Thoracic Society’s International Conference. “We are enthusiastic to be welcomed back to ATS 2022 and a safe return to the live, in-person conference,” said a news release. Last year over 8,300 professionals attended their sophomore virtual show. This will be ECO PHYSICS, INC.’s 22nd straight year as an exhibitor. The annual ATS International Conference is the annual home of pulmonary, critical care, and sleep professionals, from those in the earliest stages of their careers to those whose research or strides in clinical care have gained them international recognition. In years past, on average 11,000 of these respiratory professionals chose to attend, present, and learn about the latest advances. This year’s Conference will be held May 13th-18th. ECO MEDICS offers a broad range of research Pulmonary Function Testing (PFT) capabilities, including Lung Clearance Index (LCI). The EXHALYZER D provides sensitive multiple breath washout measurements, revealing detailed information on the small airways. The Analyzer CLD 88sp instrument is used for exhaled nitric oxide (FeNO), alveolar, and nasal NO measurements. ECO PHYSICS, INC. is the sole North American distributor of ECO MEDICS AG FeNO & nitrogen multiple breath washout (N2MBW) lung mechanics measurement systems. These scientific instruments are for research purposes only and are not FDA or Health Canada approved.

Babies of Pregnant Women Who Get RSV Vaccine Likely to Be Prescribed Fewer Antimicrobials

MAR 15 2022

Babies born to moms who were vaccinated against respiratory syncytial virus (RSV) while pregnant appear to need fewer antimicrobial prescriptions than babies of unvaccinated moms, according to a study. To fight antimicrobial resistance, we need to use fewer antimicrobial drugs, the authors write in Proceedings of the National Academy of Sciences (PNAS). "In this study, an RSV vaccine was administered to pregnant women to prevent infection in their infants by the transfer of protective antibody to the infant," Kathryn M. Edwards, MD, a professor of pediatrics and the scientific director of the Vanderbilt Vaccine Research Program at Vanderbilt University School of Medicine in Nashville, Tennessee, said. Edwards was not involved in the study. "The authors investigated the impact of the vaccine on the use of antibiotics in infants during the first 90 days of life," Edwards added in an email. "They found that the use of antibiotics was less in infants born to mothers who received the RSV vaccine than in infants born to mothers who received placebo…They suggest that reducing RSV infection in infants will reduce respiratory infections that trigger antibiotic use." Senior author Ramanan Laxminarayan, PhD, MPH, director and senior fellow at the Center for Disease Dynamics, Economics, & Policy (CDDEP) in Washington, DC, and his colleagues conducted a secondary analysis of a double-blind, randomized controlled trial at 87 sites in 11 countries on several continents. In the original study, which was conducted between December 2015 and May 2018, 3005 maternal participants and 2978 infant participants received the experimental RSV F vaccine, and 1573 maternal participants and 1546 infants received a placebo shot. Baseline characteristics of mothers and infants were well balanced, according to the authors. In the current study, infants born to mothers who received the RSV vaccine were found to be 12.9% (95% CI, 1.3 - 23.1%) less likely to be prescribed antimicrobials during their first 3 months of life compared with infants whose mothers received placebo. Vaccine efficacy against antimicrobial prescriptions for acute lower respiratory tract infections was 16.9% (95% CI, 1.4 - 29.4%). During the first 3 months of life, for every 100 infants born, maternal vaccination prevented 3.6 courses of antimicrobials in high-income countries (20.2% of all antimicrobial prescribing), and 5.1 courses in low- and middle-income countries (10.9% of all antimicrobial prescribing). In addition to finding that lower respiratory tract infections accounted for 69%–73% of all antimicrobial prescribing prevented by maternal vaccination, the researchers found marked vaccine efficacy (71.3% [95% CI, 28.1 – 88.6%]) against acute otitis media-associated antimicrobial prescription in infants in high-income countries.

Combined Beta-Agonist/Steroid Inhaler Helps Control Mild Asthma in Adults

MAR 15 2022

A single combined-drug inhaler used as needed protects adults with mild asthma from worsening illness and hospital stays, a recent commentary on Cochrane systematic review data reports. But long-term medication and use by children under 12 years of age need to be studied, and regulatory agencies in countries including the United States have not yet approved the combined delivery. "The data in this review are encouraging for the use of as-needed FABA/ICS [fast-acting beta2-agonist / inhaled corticosteroid] over as-needed FABA alone for mild asthma to reduce exacerbations requiring systemic steroids, healthcare utilization and side-effects from systemic steroids," co-authors Dan Morgenstern-Kaplan, MD, and Alexei Gonzalez-Estrada, MD, of the Division of Pulmonary, Allergy, and Sleep Medicine of Mayo Clinic in Jacksonville, Florida, write in an online commentary in Clinical & Experimental Allergy. "These findings are consistent with current guidelines for the use of as-needed FABA/ICS over as-needed FABA alone in mild asthma," they add. Senior author Timothy S.C. Hinks, MA, PhD, a fellow and consultant at the University of Oxford, United Kingdom, and colleagues conducted a Cochrane systematic review of combination fixed-dose beta-agonist and steroid inhalers for adults and children with mild asthma. They searched Cochrane and other standard medical databases for randomized controlled trials and cross‐over trials with at least a 1-week washout period through March 19, 2021, and they reported the results online BMJ Evidence-Based Medicine. The researchers included studies that were at least 12 weeks long and that involved a single, fixed‐dose FABA/ICS inhaler used as required compared with no treatment, placebo, short‐acting beta agonist (SABA) as required, regular ICS with SABA as required, regular fixed‐dose combination ICS/long‐acting beta agonist (LABA), or regular fixed‐dose combination ICS/FABA with as-required ICS/FABA.

New Gene Signals for Asthma-COPD Overlap Identified

MAR 15 2022

A large-scale analysis of the genetic underpinnings of the overlap between asthma and chronic obstructive pulmonary disease (COPD) has identified eight novel signals that may be linked to inflammation and worse asthma outcomes, according to an international team of investigators. They conducted a genome-wide association study (GWAS) of 8068 individuals with asthma-COPD overlap (ACO) and 40,360 controls with either asthma or COPD alone and identified genetic variants that could predispose patients to ACO. The findings by Catherine John, MBBChir, from the University of Leicester, United Kingdom, and colleagues from Europe, the United States, and Canada were published online in the journal Chest. "Our study contributes to understanding the genetic landscape of asthma and COPD at the population level," explained co-author Lystra P. Hayden, MD, from Brigham and Women's Hospital and Harvard Medical School in Boston, in an email. "It provides evidence for shared genetic influence ranging from variants implicated in asthma, to those implicated in fixed airflow obstruction, and specifically those which influence an intermediate phenotype with features of both, which was the focus of this investigation," she wrote. Although the study does not provide sufficient evidence to support patient-level genetic testing for these variants, "it does suggest potential common biological mechanisms underpinning both asthma and COPD, which in the future could inform treatments of people displaying features of both conditions," Hayden said. Asthma and COPD are distinct conditions but share certain features, such as airflow obstruction, inflammation, and cytokine profiles. Recent studies have suggested that patients with features of both conditions ― ACO ― have worse outcomes than those with either condition alone. The authors note that recent guidelines from the Global Initiative for Chronic Obstructive Lung Disease "emphasize that asthma and COPD are different conditions but may coexist in the same patient."

Azithromycin Doesn't Prevent Recurrent Wheezing After Acute Infant RSV

MAR 15 2022

Azithromycin administered for severe early-life respiratory syncytial virus (RSV) bronchiolitis did not prevent recurrent wheezing in affected children over the next 2-4 years, a randomized, single-center study found. Antibiotics are frequently given to patients with RSV bronchiolitis, although this practice is not supported by American Academy of Pediatrics clinical guidelines. Many doctors will prescribe them anyway if they see redness in the ears or other signs of infection, lead author Avraham Beigelman, MD, a pediatric allergist and immunologist at Washington University in St. Louis, said in an interview. The double-blind, placebo-controlled trial, presented at the 2022 meeting of the American Academy of Allergy, Asthma & Immunology in Phoenix, was simultaneously published online Feb. 27, 2022, in the New England Journal of Medicine–Evidence. Since azithromycin has shown anti-inflammatory benefit in chronic lung diseases and is a mainstay of care in cystic fibrosis and had shown previous effects in RSV patients, this trial examined its potential for preventing future recurrent wheezing in infants hospitalized with RSV who are at risk for developing asthma later. About half of children admitted to the hospital for RSV will develop asthma by age 7, Beigelman said. "We were very surprised that azithromycin didn't help in this trial given our previous findings," Beigelman said. And while those given azithromycin versus those given a placebo showed no significant decrease in recurrent wheezing, there was a slight suggestion that treatment with antibiotics of any kind may increase the risk of later wheezing in infants hospitalized with the virus. "The study was not designed to tease at the effects of different antibiotics or combinations of antibiotics, so we have to be very cautious about this trend," Beigelman said. "There may be short-term effects and long-term effects. Certain antibiotics may affect the infant microbiome in other parts of the body, such as the gut, [in] a way that may predispose to asthma. But all these associations suggest that early-life antibiotics for viral infections are not good for you."

He pointed to the longstanding question among clinicians whether it is the antibiotic that's increasing the risk of the harm or the condition for which the antibiotic is prescribed. These exploratory data, however, suggest that antibiotics for RSV may be causing harm. In pursuit of that hypothesis, his group has collected airway microbiome samples from these infants and plan to investigate whether bacteria colonizing the airway may interact with the antibiotics to increase wheezing. The researchers will analyze stool samples from the babies to see whether the gut microbiome may also play a role in wheezing and the subsequent risk of developing childhood asthma.

Company Launches new Meter System

MAR 10 2022

Nova Biomedical announced the launch of the Nova Max Pro Creatinine/eGFR Meter System in all CE countries. Nova Max Pro is an important new tool to improve kidney care through kidney function screening and early detection of kidney disease in point-of-care settings outside the hospital. The Nova Max Pro easy-to-use meter and creatinine biosensor measure blood creatinine and calculate estimated glomerular filtration rate (eGFR), two important indicators of overall kidney function, from a tiny 1.2 microliter capillary fingerstick blood sample in just 30 seconds. The Nova Max Pro measurement technique is virtually identical to the use of a glucose meter by people with diabetes. Creatinine and estimated glomerular filtration rate (eGFR) results are reported using the CKD-EPI equation (with or without race as a factor) from a small, fingerstick blood sample that eliminates the need for venous blood sampling. Patient creatinine and eGFR test results are displayed in seconds and can be stored on the meter or wirelessly communicated to Bluetooth enabled applications for review and intervention by healthcare professionals. Chronic kidney disease (CKD) is a major healthcare crisis and is growing at an accelerated rate, rising from 13th to 10th place in the World Health Organization ranking of most common causes of death. Kidney disease is often termed the “silent killer” because it shows no symptoms and is often diagnosed at a late stage when there are few treatment options other than dialysis, a very difficult end-stage treatment for the patient and a very expensive one for the healthcare system. If detected early, kidney disease progression can be prevented or delayed. According to Doug Curley, Nova Sales Product Manager, “Today the availability of new drugs to retard the progression of kidney disease makes it even more important to detect kidney disease early so treatment can be started before it is too late. Nova Max Pro is a very rapid, accurate breakthrough that improves kidney care by bringing screening and early detection of kidney disease to locations outside the hospital such as pharmacies, clinics, and physician offices.” Nova Max Pro Creatinine measuring technology is based on the Nova StatSensor Creatinine technology which has been used in point-of-care applications for over 15 years. Nova’s technology has been proven in clinical studies in numerous non-hospital settings, including pharmacies, community health centers, imaging centers, clinics, physician offices, and home testing by individuals. One pharmacy study in Spain used Nova creatinine/eGFR measuring technology to screen patients who were asymptomatic for CKD but were either on potentially nephrotoxic medications or at risk for chronic kidney disease. A remarkable 44% of the patients tested had an eGFR <60 (the level indicating kidney disease), highlighting the value of kidney disease screening in the pharmacy outpatient setting. Another large university study sponsored by the International Society of Nephrology examined the feasibility of community screening of at-risk individuals in three rural, low-middle-income countries (LMIC). The study validated that it is feasible to implement a comprehensive program utilizing POC testing and protocol-based management to improve the recognition of kidney disease in high-risk patients in these rural settings. Nova Max Creatinine/eGFR is also being used in an ongoing study that spans 25 countries and is focused on screening of asymptomatic but potentially at-risk patients in clinics and physician offices for kidney disease. The thesis for this study is that early detection will improve outcomes for patients by allowing early treatment.

Company Taken Over by Own Employees

MAR 4 2022

Dale Medical Products, Inc., a well-known manufacturer of medical devices, announced it has completed a transaction to become 100% employee-owned through its newly created Employee Stock Ownership Plan (ESOP). Dale’s founder, David Kaplan, repeatedly stated his desire to conduct his business and share the success of the company with all its hard-working employees. He did this by rewarding office and factory workers alike with competitive salaries, and hourly rates, good working conditions, and benefits including health insurance and a generous profit-sharing/retirement plan. Through the successive leadership under Irving Brezack and then John Brezack, this tradition has continued without interruption. John Brezack commented on Dale’s history; “Since our founding in 1961 and as President since 1997, my philosophy has been to empower our employees to produce our products and work with our suppliers and customers as if they were direct stakeholders in Dale. I am extremely pleased that my vision has become fully realized. Our employees can now have an additional level of confidence that Dale is here to serve the needs of its customers over a much longer horizon. I am excited to sell the company to our employees themselves, so they could continue our Dale brand, our vision, and our unity as a unique company and culture.” Bob Simpson, the new President and Chief Executive Officer of Dale comments “As an employee-owned company, we will preserve the Dale legacy of providing highly trusted medical products to help caregivers and patients worldwide. Our employees have always taken extraordinary pride in the positive impact we have on patient care, and now they can benefit further as stakeholders in our company.” Dale Medical Products, Inc. was founded in 1961, in Sharon, Massachusetts. From a modest beginning the company has grown into an industry leader in the market niches it serves worldwide. Today, Dale is headquartered in Franklin, Massachusetts where their corporate office and manufacturing facilities are located.

Vapotherm Launches Strategic Partnership with Carnegie Mellon University

MAR 4 2022

Vapotherm, Inc., a global medical technology company focused on developing innovative, non-invasive technologies and digital health solutions for respiratory patients, today announced a strategic partnership with Carnegie Mellon University, a world class AI research institution, to deliver a tailored artificial intelligence (AI) program for Vapotherm employees. The aim of the AI program, named Vapotherm AI for Business, is to tap into Carnegie Mellon’s AI expertise to provide a customized training program for Vapotherm employees that incorporates the use of AI to deliver better care, improve the quality of life, reduce the impact of chronic respiratory diseases, and lower healthcare costs for its customers. “With the rapid growth of digital health technologies, connected medical devices, and expansion of individual patient longitudinal data sets of respiratory symptoms, Vapotherm is embracing the use of AI and machine learning (ML) to scale digital capabilities,” stated Joe Army. “We are excited to partner with Carnegie Mellon to help our team understand how to safely, ethically, and rapidly incorporate AI in order to deliver better solutions for our Patients, clinicians, and customers.” This unique program, designed by the Executive Education team at Carnegie Mellon’s Tepper School of Business, will deliver a tailored curriculum to Vapotherm employees focused on topics including the application of AI and ML technologies and how to integrate AI into the delivery of their products and services. The program topics will help employees learn how to deploy AI in their jobs. The Tepper School has a long history of innovating business and transforming leaders through Executive Education. U.S. News & World Report ranks CMU as the top university for graduate education in AI. “We are proud to partner with Vapotherm and to support their innovative approach to improving lives through healthcare,” says Isabelle Bajeux-Besnainou, Dean of the Tepper School. “AI is in our University culture. After years of being leaders in the field, we are uniquely positioned to equip the employees of Vapotherm with the critical methods needed to take their business and patients’ well-being to the next level.” The Vapotherm AI for Business program is scheduled to begin in early March 2022.

Free Trial of Filters Offered

FEB 21 2022

With a return to diagnostic spirometry in primary care, we know that patient safety is of paramount importance to respiratory healthcare professionals. To enable practitioners to resume testing in a safe and responsible manner, Vitalograph are offering a free trial pack of Bacterial Viral Filters to every clinic conducting spirometry tests. The pandemic has taught us that we must rethink pulmonary function testing within general practice settings. Patient and practitioner safety and the reduction of virus transmission are the main priority. With that in mind, Vitalograph have also created an essential guide that summarizes the guidance from ATS, ERS, ARTP, PCRS, and BTS into 5 key considerations. This is available to download for free from their website at the link below. Vitalograph Bacterial Viral Filters (BVF) provide an efficient hygiene solution giving better than 99.999% cross-contamination efficiency. Bacterial Viral Filters (BVFs) for safe spirometry testing Single-use BVFs are the best way to perform safe pulmonary function testing within your practice. The American Thoracic Society (ATS) and the European Respiratory Society (ERS) recommend using bacterial viral filters. Visit

Inhaler Technique Sees Improvement in Training

FEB 21 2022

With independent studies showing that 8 out of 10 people use their inhalers incorrectly, inhaler technique training supports more accurate drug delivery, helping patients get the full benefit of their medication, and resulting in better disease management.

The Vitalograph AIM (Aerosol Inhalation Monitor) is designed to assist medical practitioners in training patients to use their inhalers correctly. The AIM validates good technique in the use of both DPI and MDI inhalers. Using a hygienic, single-use disposable inhaler simulator, the AIM is the only interactive device that gives instant visual feedback on the following critical elements of inhaler technique:

• Inspiratory acceleration at start of inspiration
• Timing of firing of MDI
• Inspiratory flow rate throughout inspiration
• Inhalation time within target flow range
• Breath-hold time at end of inhalation

The Global Initiative for Asthma (GINA) acknowledges that inhalers should be prescribed only after patients have been trained to use them properly. In addition, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) states that it is essential to ensure that inhaler technique is correct and to re-check this at each visit and for each change of inhaler device. Reimbursement is available for demonstration, training, or evaluation of patient utilization of an inhaler. Which means that the AIM could bring you more than $16.96 for every patient using an inhaler with CPT code 94664. Vitalograph is launching the AIM with an introductory offer of a 30-Day Money Back guarantee and a FREE starter pack worth $27 with every device.

Speaking about the AIM, Stephen Foster, Respiratory and Allergy Specialist Pharmacist, says: “The AIM is a really useful means of training patients to use their inhalers properly and should be an essential part of a respiratory clinician’s kit in the future if we are to improve compliance and concordance in our patients.”

FDA Okays New Monoclonal Antibody That's Effective Against Omicron

FEB 15 2022

The FDA issued an emergency use authorization (EUA) for bebtelovimab, a monoclonal antibody that "retains activity against Omicron," the agency said. Bebtelovimab is authorized for the treatment of mild to moderate COVID-19 in individuals ages 12 and up who are at risk of progressing to severe disease. Importantly, "laboratory testing showed that bebtelovimab retains activity against both the Omicron variant and the BA.2 Omicron subvariant," the agency added, without providing any more specifics. The antibody is not authorized for hospitalized patients or those requiring oxygen therapy, as it has not been studied in this population and could worsen clinical outcomes, FDA said. "Today's action makes available another monoclonal antibody that shows activity against Omicron, at a time when we are seeking to further increase supply," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement. Data supporting this EUA came from the phase II BLAZE-4 trial, which in part enrolled 150 high-risk patients who were randomized to receive either bebtelovimab alone or in combination with other monoclonal antibodies. An additional 176 patients received the drug with other monoclonal antibodies in an open-label arm of the trial. FDA said that COVID-related hospitalizations and deaths were lower among patients who received bebtelovimab alone or in combination with other antibodies versus those who received placebo, but "conclusions are limited as these data are from different trials that were conducted when different viral variants were circulating and baseline risk factors varied."

Infant Bronchiolitis Subtype May Predict Asthma Risk

FEB 15 2022

Bronchiolitis is the leading cause of infant hospitalizations in the United States and Europe, and almost one third of these patients go on to develop asthma later in childhood. But a multinational team of researchers has presented evidence that could avoid that outcome. They identified four different subtypes of bronchiolitis along with a decision tree that can determine which infants are most likely to develop asthma as they get older. Reporting in the journal eClinical Medicine, Michimasa Fujiogi, MD, of Massachusetts General Hospital and Harvard University, Boston, and colleagues analyzed three multicenter prospective cohort studies that included a combined 3081 infants hospitalized with severe bronchiolitis. "This study added a base for the early identification of high-risk patients during early infancy," Fujiogi said in an interview. "Using the prediction rule of this study, it is possible to identify groups at high risk of asthma during a critical period of airway development — early infancy." The researchers identified four clinically distinct and reproducible profiles of infants hospitalized for bronchiolitis:

  • A: characterized by a history of breathing problems and eczema, rhinovirus infection, and low prevalence of respiratory syncytial virus (RSV) infection.
  • B: characterized by the classic symptoms of wheezing and cough at presentation, a low prevalence of previous breathing problems and rhinovirus infection, and a high likelihood of RSV infection.
  • C: the most severe group, characterized by inadequate oral intake, severe retraction at presentation, and longer hospital stays.
  • D: the least ill group, with little history of breathing problems, but inadequate oral intake with no or mild retraction.

Infants with profile A had the highest risk for developing asthma — more than 250% greater than with typical bronchiolitis. They were also older and were more likely to have parents who had asthma — and none had solo-RSV infection. In the overall analysis, the risk for developing asthma by age 6 or 7 was 23%.

Identifying Severe Pulmonary Hypertension in Patients With COPD

FEB 15 2022

Patients with severe pulmonary hypertension (PH) and chronic obstructive pulmonary disease (COPD) can now be identified using three widely available clinical variables, all of which can be measured non-invasively, a single-center, retrospective analysis indicates. "All PH is prognostically relevant in COPD, but severe PH is associated with severely decreased survival, and it is frequently associated with a different phenotype of COPD, with less severe airway obstruction but more severe diffusion [capacity] and more severe hypoxemia as well," Gabor Kovacs, MD, associate professor of pulmonology, Medical University of Graz, Graz, Austria, explained. "We believe that patients with this specific phenotype might benefit from individualized therapy, but we need to identify them first and we need non-invasive tools to [select out] patients with this phenotype from the large number of COPD patients without it," he added. The study was published online in the journal CHEST. A total of 142 patients with COPD who had undergone clinically indicated right heart catheterization for suspected PH were included in the analysis. "The diagnosis of COPD and the severity of airflow limitation were established according to the GOLD [Global Initiative for Chronic Obstructive Lung Disease] recommendations," Kovacs and colleagues note.

Stratified for severity of PH, 74 participants had severe PH, 45 had moderate PH, and only 23 patients had no PH, investigators observed. COPD with severe PH was defined as a mean pulmonary arterial pressure (mPAP) ≥ 35 mm Hg or mPAP ≥ 25 mm Hg with a low cardiac index of less than 2.0 L/min/m2. COPD with moderate PH was defined as mPAP 25-34 mm Hg or mPAP of 21-24 mm Hg with pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU). COPD without PH was defined as a MPAP < 21 mm Hg or mPAP of 21-24 mm Hg with a PVR < 3 WU. Three independent predictive variables were included in the multivariable prediction model for severe PH:

  • Systolic pulmonary arterial pressure (sPAP) ≥ 56 mmHg, estimated by echocardiography
  • N-terminal pro-brain natriuretic peptide (NT-proBNP) plasma levels ≥ 650 pg/mL
  • The ratio of the main pulmonary artery/ascending aorta diameter at the tubular site (PA/Ao-ratio) in chest CT ≥ 0.93

When all three criteria were met — which occurred in one third of the cohort — the specificity of the predictive model was 94.9% and the positive predictive value for severe PH was 93.5%. In fact, the presence of at least one of the criteria (84% of cases) had a sensitivity of 98.2% and most patients with COPD and severe PH could be detected by the recognition of a severe elevation in PAP, investigators noted.

FDA Delays Action on Pfizer Vaccine for Kids Under 5

FEB 15 2022

The FDA said it would delay a decision on authorizing the use of the Pfizer vaccine for younger children until data on the effects of three doses is available. Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said the plan for a meeting next week of the FDA’s Vaccines and Related Biological Products Advisory Committee was to “understand if two doses would provide sufficient protection to move forward.” Pfizer has asked the FDA to authorize the use of its mRNA vaccine for children under the age of 5. But, Marks said, “in looking through the data we realized now … that at this time it makes sense for us to wait until we have the data of the evaluation of a third dose before taking action.” In response to a question, Marks said the decision should be reassuring for parents and the public. “If we feel something doesn’t meet (our) standard, we can’t go forward,” he said. “Rather than an issue of having anyone question the process, I hope this reassures people that the process has a standard.” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, predicted in January that the Pfizer vaccine for younger kids could be available this month. But, he also predicted three doses would be required. Pfizer announced previously that it planned to submit data to the FDA during the first half of 2022 if the three-dose study was successful. At that time, Pfizer said it didn’t identify any safety concerns with the 3-microgram dose for children ages 6 months to 4 years, which is much lower than the 30-microgram dose given to adults.

Masimo Adds Telehealth to Its SafetyNet Telemonitoring System

FEB 10 2022

Masimo announced a major expansion of Masimo SafetyNet that brings robust, secure video conferencing to the remote patient management and connectivity platform to offer a comprehensive telehealth and telemonitoring solution—and for patients, a better “hospital at home” experience. Now, Masimo SafetyNet allows clinicians and hospitals to schedule and conduct multi-way audio- and video-based virtual appointments with at-home patients through the Masimo SafetyNet smartphone app—while still viewing continuous and spot-check vital signs and other physiological data. By combining the power of advanced remote patient monitoring, including Masimo’s clinically proven SET pulse oximetry technology, with telemedicine capabilities like virtual visits and the benefits of Masimo’s Hospital Automation platform, such as full two-way integration with hospital electronic medical records (EMRs), Masimo SafetyNet enables use of telehealth: the ability to provide full-featured remote care with virtual face-to-face meetings while simultaneously accessing a patient’s continuous physiological data. Masimo has integrated TODA, a robust audio and video transcoding technology from LMLabs, to expand Masimo SafetyNet beyond its original remote patient management capabilities. The integrated video solution dynamically adjusts bit rates based on the available bandwidth to transcode live, secure audio and video and ensure the highest quality reproduction with dramatically less required bandwidth. For clinicians, this means they get the best quality virtual visit combined with real-time patient data, no matter where the patient is. Not only are clinicians able to communicate with their patients, but also collaborate with them with the ability to share their screen, launch a digital whiteboard, chat via in-app secure messaging, or invite additional clinicians for more expertise. For patients, Masimo SafetyNet is now the easiest way to connect with their doctors and care team without having to download additional apps or send in their physiological measurements separately. Their virtual visits are conducted through the same smartphone app that collects their oxygen saturation, pulse rate, respiration rate, temperature, and other data from tetherless Masimo Radius PPG and Radius Tº sensors. Through the new virtual whiteboard, providers can educate and share additional information as part of the discussion, enriching patient-clinician interactions and allowing them to be tailored to meet each patient’s health and communication needs. The integrated messaging feature offers yet another way for patients to stay in touch with their care teams, when a full video consultation is not needed. Joe Kiani, Founder and CEO of Masimo, said, “Masimo SafetyNet has been helping clinicians save and improve patients’ lives at home and in the hospital, around the world, since the start of the pandemic. With the addition of advanced telehealth capabilities, our already powerful remote monitoring solution becomes an even more comprehensive platform.” Designed to help providers remotely manage patient care, Masimo SafetyNet is a secure, scalable, cloud-based patient management platform that features clinical-grade spot-checking and continuous measurements, CarePrograms (customizable digital care plans), remote patient surveillance, and flexible, automated, two-way integration with hospital EMR systems – now augmented with video telemedicine. First developed for use during the COVID pandemic, for lower-acuity patients recovering or quarantining at home, Masimo SafetyNet has expanded use to post-surgical patients, patients with a variety of chronic conditions, and to patients with episodic illnesses, including fever. The platform helps seamlessly extend care from the hospital to the home (or any other location outside of the hospital or doctor’s office) by collecting monitoring data from the fingertip and chest-worn sensors, relayed to the patient’s smartphone with Bluetooth, and from there to the secure Masimo SafetyNet cloud. Using the web-based clinician portal, doctors and other clinicians can keep an eye on patients’ physiological progress from afar, intervening if a patient’s condition appears to worsen, and now with the ability to conduct comprehensive virtual visits as well.

Temple University Hospital Adopts Masimo Centroid

FEB 7 2022

Masimo and Temple Health announced that Temple University Hospital (TUH), a 722-bed academic medical center located in Philadelphia, is expanding its use of Masimo technologies with Centroid, an advanced wireless patient position, orientation, activity, and respiration rate sensor, at 100 beds across its ICU units. Centroid helps clinicians monitor patient position to avoid preventable pressure injuries, and can alert clinicians to sudden movements such as fall-like events. In addition, Centroid detects chest movements to continuously provide respiration rate, assisting clinicians with additional data that may inform care decisions. Centroid pairs with the Root Patient Monitoring and Connectivity Platform using Bluetooth to track a patient’s posture, orientation, and activity, providing the ability to monitor patient position and detect changes in position. The data transmitted by Centroid can be displayed in various formats on Root, giving clinicians multiple ways to assess adherence to protocols regarding tissue stress and to tailor care to the specific needs of each patient. In addition, Centroid data can be relayed via the Masimo Hospital Automation platform to Patient SafetyNet, Masimo’s centralized remote patient supplemental monitoring platform, and Replica, a mobile application that allows clinicians to view continuous data regardless of location. At TUH, all ICU beds are being equipped with Root and with Centroid, including the Trauma ICU, Cardiothoracic ICU, Burn ICU, Neurological ICU, and Medical Respiratory ICU. Angelo Venditti, DNP, RN, Executive Vice President for Patient Care and Chief Nursing Executive at Temple Health, said, “We are pleased to expand our relationship with Masimo, which has already proven itself as a key technology partner in our efforts to improve patient outcomes. When we trialed Centroid, we found it helped our teams prioritize workflows more effectively, with increased focus on following turn protocols and decreased incidence of pressure injuries.” Hospital-acquired pressure injuries (HAPI), commonly known as bed sores, are on the rise – occurring in nearly 5% of all hospitalized patients in the US. Elderly and critically ill patients are often at highest risk for developing a HAPI, which can lead to further treatments and extended lengths of stay in the hospital. To compound the patient impact associated with these pressure injuries, there is a major economic burden for the hospital as well. Pressure injuries are classified as a “Hospital Acquired Condition”, or HAC, and the treatment costs associated with HACs are non-reimbursable to the hospital. One pressure injury can quickly add up to tens of thousands of dollars. Many facilities in the US spend millions each year treating these wounds. Pressure injuries are also a reportable quality metric to CMS. According to the National Pressure Injury Advisory Panel (NPIAP), scheduled turning protocols are known to prevent HAPIs, yet most hospitals in the US still use techniques such as paper wall clocks or egg timers to try and optimize this practice – methods that are proving to be ineffective and archaic in modern healthcare. Staffing issues and competing priorities have strained nurses across the US, and staying on top of when a patient was last turned is difficult without a more sophisticated system. Centroid is a single-patient-use adhesive sensor indicated for the orientation monitoring of patients who may be susceptible to pressure ulcers by tracking patient movement and activity using an accelerometer and gyroscope. Centroid can identify a patient’s position and orientation to the nearest degree, with alerts based on the duration in a static position to help clinicians adhere to hospital patient turn protocols. Centroid also features customizable alarm zones to help avoid patient positions that could negatively impact recovery time. Unlike simple time-based rotation protocols, Centroid provides an advanced pressure risk algorithm that takes into account the cumulative pressure exposure time, with body segment-by-segment resolution, using the integrated gyroscope, displayed on the Root screen using color-coded markers. This can help clinicians not only identify if a patient has been turned, but also identify if the new position may still be resulting in pressure risk to the same tissue—and ultimately, helping to guide clinical decisions about the most appropriate, least risky positions for each patient. Temple Health and Masimo have been pulse oximetry technology partners since 2008. Temple implemented Masimo Patient SafetyNet in 2014, has since expanded their Patient SafetyNet system to seven units, and has also adopted Masimo SpHb noninvasive hemoglobin monitoring, NomoLine capnography, SedLine brain function monitoring, O3 regional oximetry, and now the Centroid patient positioning tracker. Joe Kiani, Founder and CEO of Masimo, said, “We are honored to continue to be able to equip Temple—one of the country’s premier medical institutions—with so many of our life-saving solutions, from monitoring technologies like SET pulse oximetry and rainbow Pulse CO-Oximetry, to advanced monitors like Root and Hospital Automation solutions like Patient SafetyNet. With the addition of Centroid, Temple adds another key Masimo innovation to their toolkit. It’s a great example of our commitment to developing new ways to provide the highest quality, most relevant data to clinicians in the most intuitive, useful formats. We look forward to helping Centroid prevent many HAPIs and improve the outcomes and lives of their patients.”

Vitalograph announces the much-anticipated arrival of the new Alpha Spirometer

Jan 28 2022

Vitalograph has announced that their highly portable, lightweight, all-in-one desktop spirometer and printer is now available in the USA. The next-generation Alpha Spirometer, with integrated printer, is a lightweight and durable tool for accurate respiratory diagnosis of both adults and pediatrics. Capture reliable test results immediately with Alpha’s Fleisch measuring technology, which is extremely accurate and stable over time. Designed for testing on the go, remotely, or in a clinic, the Alpha is the ultimate desktop spirometry solution. Crucially, compliance with the 2019 ATS/ERS spirometry guidelines ensures that all respiratory diagnostics carried out are in line with international standards for accuracy and reporting. Vitalograph’s Executive Vice President of Sales &amp; Operations for North America, Troy Pridgeon said: “It is very exciting and great timing to have another next generation product available just as many healthcare sites are looking to reopen spirometry testing in the wake of the pandemic. COVID has kept patients with lung diseases and those that work around known respiratory hazards untested for as long as two years in some cases. The Alpha is a great solution to catch that up and help ensure that one health crisis doesn’t create another.”

US FDA Labels Philips' Expanded Ventilator Recall as Most Serious

Jan 28 2022

The US Food and Drug Administration (FDA) on Wednesday classified an expanded recall of certain ventilators by Philips (PHG.AS) late last year as Class 1, or the most serious type, saying they could lead to injuries or death. The Dutch medical equipment company initiated the recall of 215 Trilogy Evo ventilators and 51 repair kits in the United States due to potential health risks from a type of foam used in the devices. So far, there have been no reported injuries or deaths from the products, which were distributed in the United States and Korea, the FDA said. "We have already reached the majority of affected customers and we will correct this issue via a repair (replacement of the foam) on site in the coming months" a company spokesperson said in an emailed statement to Reuters. This is the latest recall by Philips to be labeled Class 1 after it pulled back up to 4 million breathing-aid machines last year amid concerns that a polyurethane foam used in the devices could degrade and become toxic.

Simple Screening Tools Could Help Identify COPD in Low-, Middle-Income Countries

Jan 28 2022

Undiagnosed but clinically significant chronic obstructive pulmonary disease (COPD) may be widespread in many low- and middle-income countries, according to a large international study led by researchers at University College London (UCL). But the study found that a short questionnaire combined with peak expiratory flow provides a simple and cost-effective way to identify people at high risk of COPD in these settings. COPD, including emphysema and chronic bronchitis, affects more than 300 million people globally. It is the third leading cause of mortality worldwide, with around 3 million deaths from COPD each year. However the burden of chronic lung disease is not shared equally around the world. Around 90% of deaths from COPD occur in low- and middle-income countries. Globally COPD is also a major risk factor for poorer COVID-19 outcomes. Professor John Hurst, principal investigator on the study, said: "In contrast to studies in high-income settings, our results suggest that screening for COPD in low- and middle-income countries finds undiagnosed, yet clinically significant disease - arguing for a more proactive approach to respiratory care.

"Our findings support the accuracy and feasibility of using simple screening tools to identify people affected by COPD living in diverse low- and middle-income settings." In high-income countries, COPD can be readily diagnosed using spirometry. The main risk factor for COPD in this population is smoking, and screen-detected disease is usually mild or moderate. In poorer countries the situation is more complex. Additional risk factors include smoke from biomass fuels used for cooking or heating, and poverty-associated factors such as impaired lung development and tuberculosis. Yet spirometry remains impractical as a screening tool in many resource-poor areas because of the need for equipment, training, and interpretation from skilled personnel. More cost-effective screening tools are needed in these settings to identify people who require further confirmatory testing.

Pneumonia in Infancy Predicts Respiratory Problems in Early Childhood

JAN 14 2022

Preschoolers who experienced community-acquired pneumonia in infancy were significantly more likely than those with no history of pneumonia to develop chronic respiratory disorders, based on data from approximately 7000 individuals. “Lower respiratory tract infections (LRTI) during the first years of life cause injury to the rapidly developing lung at its most critical stage,” wrote Rotem Lapidot, MD, of Boston University, Massachusetts, and colleagues. Previous research has linked pneumonia with subsequent chronic cough, bronchitis, and recurrent pneumonia in children, but data are needed to assess the impact of early community-acquired pneumonia (CAP) on respiratory health in otherwise healthy infants, the researchers said. In a retrospective matched cohort study published in Respiratory Medicine, the researchers identified 1343 infants who had CAP in the first 2 years of life, and 6715 controls using a large electronic health records dataset (Optum EHR dataset) for the period from January 2011 through June 2018. The primary outcomes were the development of any chronic respiratory disorders, reactive airway disease, and CAP hospitalizations between ages 2 and 5 years. Infants in the CAP group were otherwise healthy; those with congenital or other conditions that might predispose them to pneumonia were excluded. Baseline characteristics were similar between the CAP patients and controls. Overall, the rates per 100 patient-years for any chronic respiratory disorder were 11.6 for CAP patients vs 4.9 for controls (relative risk 2.4). Rates for reactive airway disease and CAP hospitalization were 6.1 vs 1.9 per 100 patient-years (RR 3.2) and 1.0 vs 0.2 per 100 patient-years (RR 6.3) for the CAP patients and controls, respectively. The distribution of CAP etiology of CAP in infants at the first hospitalization was 20% bacterial, 27% viral, and 53% unspecified. The relative rates of later respiratory illness were similar across etiologies of the initial hospitalization for CAP, which support the association between infant CAP and later respiratory disease, the researchers said. Nearly all (97%) of the CAP patients had only one qualifying hospitalization for CAP before 2 years of age, and the mean age at the first hospitalization was 8.9 months. “Rates and relative rates of any chronic respiratory disorder, and our composite for reactive airway disease, increased with age at which the initial CAP hospitalization occurred,” and were highest for children hospitalized at close to 2 years of age, the researchers noted. “Our findings add to the evolving hypothesis that persistent inflammation following pneumonia creates an increased risk for subsequent respiratory disease and exacerbations of underlying disease,” the researchers wrote in their discussion of the findings.

Asthma Treatment Does Not Raise Risk of Neuropsychiatric Disease

JAN 14 2022

Use of a leukotriene receptor antagonist (LTRA) for asthma management did not increase the risk of neuropsychiatric disease, based on data from more than 60,000 asthma patients. Although LTRAs are established as an effective drug for asthma, the US Food and Drug Administration warnings of the risk for neuropsychiatric (NP) drug reactions — including a black box warning for montelukast (Singulair) — has raised concerns, writes Ji-Su Shim, MD, of Ewha Womans University, Seoul, South Korea, and colleagues. However, evidence for such an association is limited, and previous studies have focused only on children and adolescents, and on a single LTRA (montelukast), the researchers say. In a study in the Journal of Allergy and Clinical Immunology: In Practice, the researchers used a Korean national health insurance database to identify 61,571 adult patients with asthma aged 40 years and older between January 2002 and December 2015 with no history of LTRA use. The patients underwent screening examinations between January 2009 and December 2010, which marked the start of a follow-up period ending on December 31, 2015. The median age of the study population was 61 years, and the mean follow-up period for NPs or other outcomes was approximately 47.6 months for LTRA users and 46.5 months for nonusers. Overall, 11.1% of the study population used pranlukast (Onon), 11% used montelukast, and 0.24% used zafirlukast (Accolate). A total of 12,168 patients took an LTRA during the follow-up period. The hazard ratio for newly diagnosed neuropsychiatric diseases was not significantly different between LTRA users and nonusers (hazard ratio 1.01, P = .952) in an adjusted model that included age, sex, pack-years of smoking, alcohol use, physical activity, body mass index, comorbid conditions, other respiratory diseases, and use of other asthma medications. The most common NPs were dementia, mood disorders, and panic disorders, and the prevalence of each was not significantly different between LTRA users and nonusers (75.4% vs. 76.1% for dementia, 12.7% vs. 12.8% for mood disorders, and 5.6% vs. 3.5% for panic disorders).

Exercise Easier With Ventilation in Severe COPD

JAN 14 2022

Noninvasive ventilation (NIV) delivered using a ventilator and a full-face mask during exercise reduced dynamic hyperinflation (DH) and improved exercise duration compared with no NIV in patients with severe and very severe chronic obstructive pulmonary disease (COPD), a small, randomized, crossover trial has indicated. Moreover, endurance time was increased whether NIV was used with standardized expiratory positive airway pressure (S-EPAP) or the more complex, individually titrated (T-EPAP), the same study showed. "DH [happens when] a patient is unable to fully exhale before they need to breathe in again and during exercise — where they need to breathe in more — patients end up with a slowly increasing end expiratory volume, so it's like trying to breathe in with a full lung," Clancy Dennis, a student at the University of Sydney, Sydney, Australia, and colleagues said in an email. "Once breathing volumes reach a critical threshold, breathlessness increases exponentially and exercise usually stops quite quickly so by using NIV to help people with COPD breathe bigger breaths and with less energy expended, they were less hyperinflated at [test time] and ultimately did more exercise," he added.

FDA Approves Tezepelumab-ekko (Tezspire) for Severe Asthma

DEC 30 2021

FDA has approved Tezspire (tezepelumab-ekko) injection as an add-on maintenance treatment used to improve severe asthma symptoms when used with a patient’s current asthma medicine. Tezspire is approved for adults and children aged 12 years and older with severe asthma not controlled by their current asthma medicine. Tezspire is the first asthma treatment targeting thymic stromal lymphopoietin, a molecule involved in airway inflammation. Tezspire is also the first treatment for severe asthma that is not limited to a specific type of severe asthma. Tezspire is administered once every four weeks by a health care professional through a subcutaneous (under the skin) injection. Asthma is a long-term inflammatory disease that causes the airways of the lungs to become swollen or inflamed and can be triggered by several factors, including allergen or irritant exposure and viral infections. An asthma attack (exacerbation) can include wheezing, cough, chest tightness, and make it hard to breathe. Severe asthma attacks can be intense, last for long periods of time, and impact daily activities. Severe asthma symptoms usually do not get better with use of short-term treatments. Approximately 5-10 percent of Americans with asthma have severe asthma. Safety and effectiveness of Tezspire were demonstrated in two clinical trials where participants with severe asthma received Tezspire 210 mg or placebo subcutaneously once every four weeks for 52 weeks. Participants receiving Tezspire had significant reductions in the annualized rate of asthma attacks compared to placebo. Additionally, there were fewer asthma attacks requiring emergency room visits and/or hospitalization among participants treated with Tezspire compared to placebo. The benefits of Tezspire seen in participants weren’t limited by specific severe asthma type.

REACT Study: Allergy Therapy Improves Asthma Long Term

DEC 30 2021

A European-based real-world study has found that allergen immunotherapy for allergic rhinitis not only has longer-term effectiveness than clinical trials have demonstrated but also may enable people with asthma to use fewer asthma medications and overall reduce their chances of developing pneumonia for up to 9 years on treatment. Reporting online in The Lancet Regional Health – Europe, the study authors claim it is the largest and most comprehensive real-world effectiveness study of allergen immunotherapy for allergic rhinitis (AR) and asthma, and that it adds new information on how allergen immunotherapy works long term. "This confirms what allergists already know," said Jonathan A. Bernstein, MD, an allergist at the University of Cincinnati. "Real-world evidence is very important to validate studies that confirm pivotal trials." REACT — Real-world Effectiveness in Allergy Immunotherapy — is a retrospective cohort study of 92,048 patients with AR with and without asthma split between two groups: those treated with allergen immunotherapy; and an untreated control group. The average patient age was 29.5 years. A preexisting asthma cohort included 29,228 patients; a no-asthma cohort included 54,274 patients. Patient data were extracted from a German health insurance fund database of 5.9 million claims and covered a 10-year period ending in 2017. Lead author Benedikt Fritzsching, MD, a pediatric pulmonologist at Children's Doctor Service and the University of Heidelberg in Germany, said the rationale for the study was to obtain long-term, real-world data of allergen immunotherapy, which had been lacking. "Allergen immunotherapy is considered the only causal treatment for allergy, and on a mechanistic immunological basis, peripheral immune-tolerance is thought to be the major mechanism of allergen immunotherapy," Fritzsching said. "However, data demonstrating long-term effectiveness, which you should expect from a causative treatment with the potential to cure allergy, was missing, especially form the real-world setting." The study findings don't only complement the evidence from randomized control trials, he said, but they further support clinical decision-making on how to use allergen immunotherapy for the treatment and sustained control of both allergic rhinitis and asthma. Overall, study patients were taking fewer anti-allergy prescriptions during the study period than before, but the patients on allergen immunotherapy had steeper reductions in years 2 through 9. By year 9, patients on allergen immunotherapy had a 62% reduction of total AR prescriptions vs 58% for controls.

Respiratory Therapists in Demand

DEC 29 2021

Respiratory therapists, who are essential to treating COVID-19 patients, top the list of most in-demand temporary allied healthcare professionals, according to a new survey by AMN Healthcare, the nation’s leader in healthcare total talent solutions. The survey of 159 hospitals, as well as other healthcare facilities, indicates that 96% have used allied healthcare professionals of various types to fill temporary assignments during the last 12 months. Respiratory therapists are most commonly used, followed by laboratory technologists, radiologic technologists, physical therapists, occupational therapists, and speech pathologists. “The widespread use of temporary allied healthcare professionals signals an emerging shortage of these workers,” said Robin Johnson, Divisional President with AMN Healthcare. “The same pattern of labor shortages prevalent in nursing and medicine now are affecting the allied healthcare professions.” Over 22 million people now are employed in healthcare and social services, the nation’s largest employment sector, the U.S. Census Bureau reports. Of these, about 60% can be characterized as allied healthcare professionals, who work in over 80 different job categories, according to the Association of Schools of Allied Health Professions (ASAHP). The survey indicates that 75% of hospitals and other healthcare facilities currently are seeking temporary allied healthcare professionals. The primary reason, cited by 73% of facilities surveyed, is to fill gaps while permanent workers are being sought, suggesting that allied healthcare professionals are difficult to find in today’s volatile labor market. The primary benefit of using temporary allied healthcare professionals, cited by 71% of facilities surveyed, is to prevent the burnout of existing staff. Due to COVID-19 and other factors, burnout and turnover among healthcare workers has escalated in recent months. According the US Bureau of Labor Statistics (BLS), 589,000 healthcare workers quit their jobs in September, 2021, representing a 35% voluntary attrition rate, a new record. The survey indicates that many healthcare facilities are using temporary allied healthcare professionals to alleviate the burden on their permanent staff and thereby reduce turnover. Most facilities surveyed (53%) said that temporary allied healthcare professionals have been either moderately or extremely involved in treating COVID-19 patients. Some allied healthcare professionals, such as respiratory therapists and laboratory technologists, are key parts of COVID-19 treatment teams. The high demand for radiologic technologists, who operate X-ray, MRI, and other imaging equipment, suggests that patient utilization of medical procedures and other services is rising after being temporarily depressed by the pandemic. Shortages of professionals could lead to delays in necessary services as demand rises, Johnson said. “Without the presence of laboratory technologists, imaging technologists, and other allied professionals, the tests and data required to conduct medical procedures and treatments backlogs, and the entire process can slow to a halt,” Johnson said. The survey indicates that temporary allied healthcare professionals are widely accepted when on assignment. Eighty-three percent of facilities surveyed indicated that temporary allied healthcare professionals are accepted by their co-workers, 94% are accepted by their managers, and 82% are accepted by patients. The great majority of those surveyed (97%) rated the skill level of temporary allied healthcare professionals average, good, or excellent.

Only Biologic for Severe Asthma Approved With no Phenotype or Biomarker Limitations

dec 17 2021

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca’s Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Tezspire was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy. “Today’s approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “Asthma is a complex and chronic inflammatory disease that affects everyone differently. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options.” Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.3It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO). Tezspire is the first and only biologic for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label. “Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalization and a significantly reduced quality of life,” said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and the principal investigator of the NAVIGATOR trial. “Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma.” “Severe asthma continues to have a debilitating impact on many of the 34 million people living with the disease worldwide, affecting their breathing and limiting aspects of day-to-day life. The approval of Tezspire is long-awaited positive news for the asthma community,” said Tonya Winders, president and chief executive officer at the Allergy & Asthma Network (AAN) and president of the Global Allergy and Airways Patient Platform (GAAPP). “For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation.” Results from the NAVIGATOR Phase 3 trial were published in The New England Journal of Medicine in May 2021. In clinical studies of Tezspire, the most common adverse reactions were nasopharyngitis, upper respiratory tract infection and headache. Tezspire is under regulatory review in the EU, Japan and several other countries around the world.

Early Diagnosis of Bronchiectasis Critical in Type 2 Severe Asthma

dec 15 2021

Type 2 inflammation likely has a causative role in the development of bronchiectasis (BE) in patients with type 2-high severe asthma (T2-SA), and its early diagnosis is critical to improve outcomes in patients with this dual diagnosis, a prospective, observational, multicenter study suggested. In a cohort of 113 patients with T2-SA, the prevalence of BE was confirmed in 44.2% of patients, Claudia Crimi, MD, AOU Policlinico "G.Rodolico-San Marco," Catania, Italy, and colleagues reported in the Journal of Asthma and Allergy. Moreover, chronic rhinosinusitis (CRS) was significantly more prevalent in T2-SA plus BE patients at 84% compared with those without BE at 58.7% (P = .004) as was chronic rhinosinusitis with nasal polyps (CRSwNP) at 54% vs 42.9% (P = .0165), researchers added. In addition, 58% of patients in the T2-SA plus BE group (compared with only 23.8% of patients in the T2-SA alone group) reported chronic mucus hypersecretion (P = .0004), whereas a greater proportion of BE patients at 56% were on maintenance oral corticosteroids (OCS) compared with 34.9% of patients without BE (P = .0357), investigators note. T2-SA plus BE patients also reported a higher number of asthma exacerbations in the previous year (10 per year) compared with 6 exacerbations in patients without BE (P = .048). "It has been hypothesized that the long-term eosinophils-mediated inflammatory damage, promoted by T2-inflammaion, induces tissues changes and airway remodeling, playing a primary role in the pathogenesis of BE," the researchers observed. "Our results confirm and expand the current knowledge reporting that T2-SA with coexisting BE was frequently associated with CRS with and without nasal polyposis, chronic sputum production, chronic OCS intake, and a higher exacerbations rate," they added.

Company Selects New Distribution Partner

DEC 3 2021

Prodol Meditec, SA, manufacturer of the Airtraq video laryngoscope and camera system, has selected Mercury Medical as their Exclusive North America Distributor partner for their state-of-the-art video laryngoscope product line effective January 1, 2022. This exclusive agreement includes distribution in Canada and Puerto Rico. Airtraq simplifies video laryngoscopy with its ETT channel guide aiding in safety and in reducing intubation time. The fully disposable system with its 90-degree shape works with the anatomy minimizing the need for hyperextension while reducing force. There is no need for a stylet avoiding potential injury while eliminating additional intubation equipment costs. Airtraq facilitates intubation from any position with clinical evidence of high intubation success rates and is easy to learn. The optional lightweight Wi-Fi camera facilitates video recording and auto recording options. Mercury Medical is a leading provider of cutting-edge technology in the acute care and emergency markets both in the United States and globally – a philosophy that is fully in line with Airtraq. John Gargaro MD, President and CEO states: “Our mission is delivering clinically differentiated critical care technology that saves lives throughout the world. As such, Mercury Medical believes that the Airtraq is a superior solution designed to improve outcomes in patients requiring intubation. As a company, Mercury Medical has a rich experience in introducing and educating clinicians on innovative, clinically differentiated medical devices. We are extremely pleased to partner with Airtraq in this endeavor to advance intubation practices. The clinical evidence supporting Airtraq’s superior performance is strong and aligned with Mercury Medical’s mission.” Danny Daniel, Airtraq’s VP of North America Sales states, “Airtraq is very excited to appoint Mercury Medical as our exclusive US partner. The core philosophy of our two companies is very much aligned together. We strive to innovate clinically differentiated products that improve provider care and saves precious lives. We look forward to a long and fruitful partnership together as we continue to bring cutting edge airway management technology to our customers.”

Rhinosinusitis Without Nasal Polyps Lowers QoL in COPD

NOV 30 2021

Concomitant rhinosinusitis without nasal polyps (RSsNP) in patients with chronic obstructive pulmonary disease (COPD) is associated with a poorer, disease-specific, health-related quality of life (HRQoL), a Norwegian study is showing. "Chronic rhinosinusitis has an impact on patients' HRQoL," lead author Marte Rystad Øie, Trondheim University Hospital, Trondheim, Norway, said in an email. "We found that RSsNP in COPD was associated with more psychological issues, higher COPD symptom burden, and overall COPD-related HRQoL after adjusting for lung function, so RSsNP does have clinical relevance and [our findings] support previous studies that have suggested that rhinosinusitis should be recognized as a comorbidity in COPD," she emphasized. The study sample consisted of 90 patients with COPD and 93 control subjects, all age 40-80 years. "Generic HRQoL was measured with the Norwegian version of the SF-36v2 Health Survey Standard questionnaire," the authors write, and responses were compared between patients with COPD and controls as well as between subgroups of patients who had COPD both with and without RSsNP. Disease-specific HRQoL was assessed by the Sinonasal Outcome Test-22 (SNOT-22); the St. Georges Respiratory Questionnaire (SGRQ), and the COPD Assessment Test (CAT), and responses were again compared between patients who had COPD with and without RSsNP. In the COPD group, "severe" and "very severe" airflow obstruction was present in 56.5% of patients with RSsNP compared with 38.6% of patients without RSsNP, as Øie reports. Furthermore, total SNOT-22 along with psychological subscale scores were both significantly higher in patients who had COPD with RSsNP than those without RSsNP. Among those with RSsNP, the mean value of the total SNOT-22 score was 36.8 whereas the mean value of the psychological subscale score was 22.6. Comparable mean values among patients who had COPD without RSsNP were 9.5 and 6.5, respectively (P < .05). Total scores on the SGRQ were again significantly greater in patients who had COPD with RSsNP at a mean of 43.3 compared with a mean of 34 in those without RSsNP, investigators observe. Similarly, scores for the symptom and activity domains again on the SGRQ were significantly greater for patients who had COPD with RSsNP than those without nasal polyps. As for the total CAT score, once again it was significantly higher in patients who had COPD with RSsNP at a mean of 18.8 compared with a mean of 13.5 in those without RSsNP (P < .05). Indeed, patients with RSsNP were four times more likely to have CAT scores indicating the condition was having a high or very high impact on their HRQoL compared with patients without RSsNP (P < .001). As the authors point out, having a high impact on HRQoL translates into patients having to stop their desired activities and having no good days in the week. "This suggests that having RSsNP substantially adds to the activity limitation experienced by patients with COPD," they emphasize. The authors also found that RSsNP was significantly associated with poorer physical functioning after adjusting for COPD as reflected by SF-36v2 findings, again suggesting that patients who had COPD with concomitant RSsNP have an additional limitation in activity and a heavier symptom burden. As Øie explained, rhinosinusitis has two clinical phenotypes: that with nasal polyps and that without nasal polyps, the latter being twice as prevalent. In fact, rhinosinusitis with nasal polyps is associated with asthma, as she pointed out. Given, however, that rhinosinusitis without polyps is amenable to treatment with daily use of nasal steroids, it is possible to reduce the burden of symptoms and psychological stress associated with RSsNP in COPD.
Limitations of the study include the fact that investigators did not assess patients for the presence of any comorbidities that potentially could contribute to poorer HRQoL in this patient population.

Sleep-Disordered Breathing Could Inflate Risk for Severe COVID-19

NOV 15 2021

People with sleep-disordered breathing or sleep-related hypoxia — low oxygen levels during sleeping — are no more likely than other adults to get infected with SARS-CoV-2 and develop COVID-19. However, if infected, they are at a 31% higher risk of getting hospitalized or dying from the illness, new research reveals. Investigators looked at almost 360,000 patients tested for COVID-19 at the Cleveland Clinic system. This group included 5400 people who also completed a sleep study. They also accounted for other factors that could alter COVID-19 risk, including obesity, heart and lung disease, cancer, and smoking. "In those with COVID-19, baseline oxygen lowering during sleep was associated with increased association with hospitalization and mortality, even after consideration of factors which could confound this relationship," Cinthya Pena Orbea, MD, said. When asked if she was surprised by the 31% increased risk, Pena Orbea said, "While this was consistent with our a priori  hypotheses and we were careful to take in to account pulmonary disease and smoking history, we still identified a statistically significant association." Pena Orbea is on staff at the Sleep Disorder Center and is assistant professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Ohio. Identifying another group at potentially higher risk for adverse outcomes could help allocate COVID-19 resources earlier or more appropriately, senior study author Reena Mehra, MD, director of sleep disorder research at Cleveland Clinic, said in a news release. "As the COVID-19 pandemic continues and the disease remains highly variable from patient to patient, it is critical to improve our ability to predict who will have more severe illness," she said.

COVID-19 Pandemic Fueled the Growth of Telemedicine in Allergy

NOV 15 2021

The use of telemedicine has historically been low among allergy practitioners compared with other specialists, but the pandemic has accelerated the growth of virtual allergy visits. "My own practice went from zero to 100% telemedicine in a matter of days," Susan Bailey, MD, an allergist at Fort Worth Allergy and Asthma Associates, in Fort Worth, Texas, and immediate past president of the American Medical Association, said during a plenary session at the American College of Allergy, Asthma, and Immunology (ACAAI) 2021 Annual Meeting, held in New Orleans. "I think the pandemic really pushed people out of necessity to adopt telehealth, or really decide if it's for them or not, quicker than they might have," said Melinda Rathkopf, MD, director of the Allergy, Asthma and Immunology Center of Alaska, in Anchorage, in an interview before co-moderating a telemedicine session at the conference. Across medicine, practitioners are seeing 50 to 175 times the number of patients through telehealth than they were before the COVID-19 pandemic, and nearly half of doctors are continuing to use telehealth as the pandemic causes shifts in practice patterns and the delivery of care. These trends are shown in McKinsey survey data that were presented at the ACAAI meeting by Jennifer Shih, MD, allergist-immunologist and assistant professor of pediatrics and internal medicine at Emory University, in Atlanta, Georgia. Several factors allowed telemedicine to grow. During the pandemic, the US Department of Health and Human Services relaxed the requirement that telehealth delivery be HIPAA compliant. Thus, physicians were able to use Zoom, Skype, Facetime, and other everyday technologies for virtual visits. In addition, the Centers for Medicare & Medicaid Services (CMS) instituted a number of changes to make telehealth more accessible — among them, recognizing a patient's home as an originating site and allowing virtual visits for new patients in addition to established ones. Before COVID-19, "I could not initiate a telehealth visit with someone I had never met in person for the first time. In Alaska, that included an in-person physical," said Rathkopf. "Those rules were all lifted during the pandemic." As more practitioners started offering telehealth, 46% of US consumers said they were using telehealth in lieu of canceled healthcare visits, up from 11% in 2019, according to McKinsey data that Shih reported at the meeting. More than three quarters of consumers said they would likely use telehealth after the pandemic. Of 297 patients who used telehealth services at Emory Allergy Clinic between March 24 and May 29, 2020, 88% of them rated their comfort level on seeing a doctor virtually with the highest score (10 out of 10) on a survey published by Shih and colleagues. Forty percent rated their telehealth visit equivalent or superior to a traditional outpatient encounter. And in a consumer survey conducted by Accenture, 64% of patients said they would change practitioners if they couldn't see the doctor via telehealth.

Novel Bronchoscopic Interventions Appear Promising for Patients With COPD

NOV 15 2021

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians. Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD. Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus. “Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year. Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas. The targeted lung denervation system under study (dNerva®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr Ghattas said. The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added. In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr Ghattas. In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts. Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration. There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts. Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P  = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Life-Threatening Paradoxical Bronchospasm May Be Missed in COPD or Asthma

NOV 15 2021

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from US military veterans. Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol. However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago. “Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year. By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr Kaul. “We hope in the future, education of clinicians about this phenomena is emphasized,” Dr Kaul said in her presentation. In an interview, Dr Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test. “I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said. Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr Kaul. If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate. Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr Kaul. Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr Kaul said.

Researchers Team Up to Study COVID-19 Impact on Lung Function

NOV 08 2021

Boehringer Ingelheim announced that the first patient has enrolled in a new clinical study to observe whether COVID-19 patients with respiratory failure are more susceptible to developing progressive Interstitial Lung Disease (ILD), or scarring of the lungs. Weill Cornell Medicine and NewYork-Presbyterian Hospital are leading the clinical trial. “There is increasing evidence that respiratory failure observed in COVID-19 infected patients leads to a progressive form of Interstitial Lung Disease,” said Rob Kaner, M.D., principal investigator, associate professor of clinical Medicine and of Genetic Medicine and director of the Interstitial Lung Disease Program at Weill Cornell Medicine in New York, and a pulmonologist at NewYork-Presbyterian/Weill Cornell Medical Center. “This prospective study will define the incidence of progressive ILD in the COVID-19 patient population and investigate if there are specific biomarkers that may identify patients at risk for progression.” The study, NCT05074875, is a 48-week observational, prospective registry study that will enroll an estimated 300 patients who were hospitalized with hypoxemic (below normal oxygen levels) respiratory failure associated with COVID-19 at Weill Cornell Medicine and NewYork-Presbyterian Hospital, and three other medical centers. The primary endpoint of the study is the change in fibrotic and non-fibrotic interstitial opacities on chest HRCT at 48 weeks after hospitalization for COVID-19 or outpatient COVID-19 infections which require treatment with supplemental oxygen. Secondary endpoints include percentage of participants with changes from baseline and evidence of disease progression based on HRCT, relative change in Forced Vital Capacity (FVC) at weeks 12, 24, 48 and 72 among other measures. “This study will help the medical community better understand the prognosis of COVID-19, namely whether a progressive form of ILD and associated biomarkers may occur following respiratory failure in COVID-19 patients,” said Craig Conoscenti, M.D., Executive Director/Therapeutic Area Head, Respiratory IPF/ILD, Clinical Development and Medical Affairs, Boehringer Ingelheim. “It is our hope that this study will take a major step forward in providing treating doctors with new information to better help hospitalized patients affected by respiratory failure due to COVID-19 infection.”

Masimo Root with a Multimodal Brain Monitoring Algorithm May Improve Postoperative Neurocognition in Elderly Patients

NOV 08 2021

Masimo announced the findings of a prospective study published in Frontiers in Aging Neuroscience in which Dr Shuyi Yang and colleagues at Capital Medical University in Beijing investigated whether Masimo Root with a multimodal brain monitoring algorithm to manage anesthesia during spinal surgery could improve postoperative cognitive function. In the first study of its kind, the algorithm incorporated measurements from Root, including Masimo SedLine Brain Function Monitoring, Masimo O3® Regional Oximetry, and ANI Analgesia Nociception Index. The researchers concluded that managing anesthesia based on the multimodal algorithm “may improve the post-operative cognitive function and brain function connectivity in elderly patients undergoing spinal surgery compared to routine anesthesia management.” Noting that perioperative neurocognitive disorder (PND) is common in elderly patients undergoing surgery, and that PND has been associated with levels of sedation, analgesia, and cerebral oxygen saturation, the researchers sought to evaluate whether use of an algorithm designed around related parameters could help improve this population’s postoperative neurocognition. They enrolled 26 patients aged ≥ 65 scheduled to undergo spinal surgery and divided them randomly into an intervention group (n=14) and a control group (n=12). In the intervention group, anesthesia was managed using the algorithm, which incorporated Sedline Patient State Index (PSi) and Spectral Edge Frequency (SEF), O3 regional cerebral oxygen saturation (rSO2), ANI pain index, mean arterial pressure (MAP), end-tidal CO2 (PETCO2), hemoglobin (Hb), and temperature. The control group received routine anesthesia management. To evaluate whether the algorithm improved cognitive function, they a) compared the patients’ Montreal Cognitive Assessment (MoCA) score before and 7 days after surgery, b) analyzed the amplitude of low-frequency fluctuation (ALFF) and brain functional connectivity (FC) after MRI, c) measured serum C-reactive protein (CRP) and lipopolysaccharide levels, and d) analyzed the correlation between FC and changes in inflammatory marker levels. The researchers found that the mean postoperative MoCA score was higher in the intervention group (24.80 ± 2.09) than in control group (22.56 ± 2.24) (p = 0.04), with no significant difference in the incidence of PND between the groups. (The MoCA score was also higher in the intervention group than in the control group preoperatively, but to a lesser degree than postoperatively.) They also found that patients in the intervention group had significantly increased ALFF values in several brain regions after surgery (p < 0.05) and enhanced FC between the left hippocampus and several regions (p < 0.05), which was negatively correlated with the change in serum CRP (pre- vs. post-intervention) (r = -0.58, p = 0.01). The authors concluded that “anesthesia management based on multimodal brain monitoring under general anesthesia may improve the postoperative cognitive function and brain function connectivity in elderly patients undergoing spinal surgery compared to routine anesthesia management, as evidenced by increased brain activity (ALFF), enhanced FC, higher MoCA score, and reduced systemic inflammation. The extent of postoperative systemic inflammation was negatively associated with the FC enhancement and may be accompanied by a lower MoCA score. Our findings provide a basis for more effective management of elderly patients who undergo surgery to reduce the risk of cognitive disorders and improve brain function. Michael A.E. Ramsay, MD, FRCA, Chair Emeritus of the Department of Anesthesiology and Pain Management at Baylor University Medical Center, commented, “Postoperative neurocognitive disorders (PNDs) are commonly seen in elderly patients, and may be very distressing to the patient and family. This small, prospective, randomized clinical study has demonstrated that precision multimodal monitoring of the brain intraoperatively can result in significantly improved mental status of surgical patients postoperatively. The study patients were maintained at a precise depth of anesthesia, cerebral oxygenation, analgesia, and temperature using the Masimo Root monitor. Postoperatively the MoCA score was statistically higher (p < 0.04) in the study group and the inflammatory marker levels in the brain were significantly reduced (p < 0.05), as well as inflammatory markers systemically (p < 0.01). A MoCA score of 25-30 represents normal cognition and 21-24, 10-20, and 9 and below, mild, moderate, and severe cognitive impairment, respectively.” Dr Ramsay continued, “This was a well implemented study, and while it may have been small, it has large implications regarding the value of precision monitoring during surgery and with the potential for application in the intensive care unit (ICU). This may represent a vital advance in the prevention of PND and also the prevention of delirium in ICU patients. Larger studies will be needed to confirm these preliminary data.” ANI on Masimo Root has not received FDA clearance and is not available for sale in the US.

Ventilator Recall Sparks Changes

NOV 08 2021

The recall of some positive airway pressure devices and mechanical ventilators prompted some researchers to study how to optimize a transition to nonrecalled devices. Researchers with the Division of Pediatric Pulmonology, Department of Pediatrics, Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, launched a retrospective study of children after a Philips Respironics recall notification issued in June 2021 that affected many of their positive airway pressure devices and mechanical ventilators including the Trilogy 100 and 200 ventilators that are often utilized in children using home positive pressure ventilation via tracheostomy (PPV‐T).

“Optimal strategies to replace ventilators in children using home PPV‐T affected by the Philips recall are unknown,” the researchers wrote in their study, entitled “Ventilator change in children on home mechanical ventilation affected by the Philips Respironics trilogy ventilator recall,” and published in October 2021. “We conducted a retrospective study of children using home PPV‐T with recalled Trilogy ventilators who underwent inpatient ventilator change to non‐recalled portable home ventilators (PHV) using our collaborative institutional protocol. During the study period, there were 40 children using PPV‐T with recalled Trilogy ventilators and 19 patients underwent inpatient ventilator change either during an elective hospitalization (n = 8) or during an unscheduled or postoperative hospitalization (n = 11). The median duration of hospitalization for ventilator change was 2 days (interquartile range: 6 days) and generally 1 day for patients admitted solely for ventilator change.” The 19 patients were changed to either Breas Vivo 65 (Breas Medical AB, n = 13) or AstralTM 150 (ResMed, n = 6) based on ventilator availability with the patient’s DME company. According to the study, the recall was due to “problems related to the polyester‐based polyurethane sound abatement foam used in the affected devices that could generate particulate matter which may be inhaled or ingested by the user, and off‐gas potentially toxic carcinogenic chemicals. In the recall notice, Philips Respironics has reported patient complaints of black particles in the airpath circuit of the devices, cough, upper airway irritation, headache, chest pressure, and sinus infection. Philips Respironics reports potential risks of particulate and chemical exposure due to off‐gassing, including irritation of the skin, eye, and respiratory tract, headache, asthma, hypersensitivity, nausea, vomiting, and toxic carcinogenic effects. Although there have been no reported deaths due to these issues, the duration of exposure required to produce symptoms is unknown.” The American Academy of Sleep Medicine, American Thoracic Society, and Canadian Thoracic Society has provided guidance for physicians managing patients affected by the Philips recall. For patients using life‐sustaining ventilators, Philips Respironics and professional societies have recommended that patients not stop therapy until after talking to their physician.

“This recall has imposed a burden on pediatric clinicians and healthcare systems requiring notification of patients using affected ventilators, reviewing the risks and benefits of continued therapy, triaging children with higher medical acuity for ventilator replacement, and arranging for replacement unaffected ventilators during a summer surge in hospitalizations due to COVID‐19 and respiratory infections,” the authors write. In the study’s discussion section, the authors concluded that while limited by the single institution retrospective study design with a small sample size, a “collaborative approach” can optimize the transition to nonrecalled devices.

“Based on consensus within our pediatric pulmonology division, this institutional protocol was formulated to facilitate and prioritize ventilator transition in children using affected Trilogy ventilators,” they write. “Since children using PPV‐T are often medically complex and fragile compared to adults, we elected to perform ventilator changes in the inpatient setting where children could be closely monitored and appropriate changes in ventilator settings could be performed, if required. A study on bench evaluation of PHVs showed wide variability in performance and triggering sensitivity that may influence assisted ventilation delivery. Moreover, the inpatient setting also permitted parental caregivers' training on using their new non‐recalled PHV. Patients who were already hospitalized, scheduled for an elective postoperative hospitalization, or reported symptoms listed in the Philips Respironics recall statement were prioritized for inpatient ventilator change. Our ventilator change protocol relied heavily on patient‐centered shared decision‐making balancing the risks and benefits of using the recalled Trilogy ventilator and hospitalization to change ventilators. Moreover, close communication and collaboration with the parental caregivers, regional DME companies, hospital bed availability, outpatient and inpatient pulmonologists, and nurse coordinators were key aspects of our protocol. Some obstacles we encountered while implementing our protocol included intermittent shortages of PHVs with the DME companies that also had to service regional adult hospitals. Therefore, we obtained a weekly inventory of available non‐recalled PHVs from the DME companies to schedule hospitalizations and PHV changes for our patients. Another challenge was unavailability of inpatient beds due to surges in COVID‐19 and other respiratory infections requiring hospitalization during the study period. Therefore, we prioritized ventilator changes in patients who were already hospitalized and hospitalizations for elective ventilator changes were scheduled when beds became available. Although the ventilator change was accomplished during a brief hospitalization in this study, we acknowledge that some parental caregivers may require additional time for ventilator training.”

Webinar Tackles Smoking Habits

NOV 2 2021

The American Lung Association in Kansas and Greater Kansas City will host a lunch and learn webinar, sponsored by Vitalograph, on Wednesday, November 17 at 12:00 p.m. The free virtual event, which takes place one day before the Great American Smokeout (an annual nationwide campaign to quit smoking), will educate health care providers, respiratory therapists, asthma educators and nurses on ways to guide patients as they begin a new, smokefree phase of their lives. Featured will be Albert Rizzo, MD, FACP, FCCP, Chief Medical Officer (CMO) of the American Lung Association. Dr Rizzo is a key medical advisor to the Lung Association, member of the Lung Cancer Expert Medical Advisory Panel and leading media spokesperson for the Lung Association. He plays a key role in multiple areas of the Lung Association’s mission, including its Lung HelpLine, research, advocacy, communications, development and health promotions. Participants will have an opportunity to earn one Continuing Respiratory Care Education (CRCE) credit by the American Association for Respiratory Care. You can sign up here. Signup Form (

Masimo Launches Dual SET Pulse Oximetry

NOV 1 2021

Masimo announced Dual SET Pulse Oximetry for Root, a highly versatile patient monitoring and connectivity hub. The first application of Dual SET Oximetry is a significant advancement to Masimo SET-guided critical congenital heart disease (CCHD) screening, with the CE marking and European launch of the Masimo SET MOC-9 module and the addition of the Eve CCHD Newborn Screening Application for Root. Together, this combined solution enhances the automation of newborn screenings using Dual SET Oximetry: two simultaneous measurements of oxygen saturation (SpO2) at pre- and post-ductal sites by the intuitive Eve application, customized to align with a hospital’s CCHD screening protocol. CCHD affects approximately 2.5 to 3 newborns per 1000 live births and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage. Traditionally, newborns were observed for evidence of CCHD by physical assessment and monitoring for common symptoms, but studies have shown that physical assessment of newborns alone can be unreliable and may fail to detect some infants with CCHD before discharge. Adding screening with pulse oximetry can help clinicians identify CCHD before an infant becomes symptomatic. Clinically proven Masimo SET Measure-through Motion and Low Perfusion pulse oximetry has been shown in more than 10 CCHD screening studies – representing over 300,000 babies – to increase the effectiveness of screening newborns for CCHD. For example, in a study of almost 40,000 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and SET. In another study of more than 120,000 infants – the largest CCHD screening study to date – combined use of clinical assessment and SET increased screening sensitivity from 77% to 93%. Evidence from CCHD studies using SET has even been used to help establish CCHD screening guidelines used around the world. Powered by Masimo SET pulse oximetry, the Eve CCHD Newborn Screening Application is designed to simplify the CCHD screening process by providing step-by-step visual instructions, animations, and a detailed, easy-to-interpret display of screening results – standardizing and enhancing clinical workflows, improving consistency in screening practices among clinicians, and reducing the possibility of calculation errors. Eve also allows clinicians to incorporate perfusion index into screening, which has been shown to increase sensitivity to the detection of CCHD. Already available for Radical-7 and Rad-97 Pulse CO-Oximeters, Eve is particularly well suited for display on Root’s large, high-resolution screen. With its built-in barcode scanner, Root can automatically associate patients with their screening results, and with its integration into the Masimo Hospital Automation platform, Root automates the transfer of those results to electronic medical records (EMRs) – eliminating the need for manual charting. Now, with the addition of the new Masimo SET MOC-9 module for Root – made possible by another key differentiator of the hub, its advanced, flexible connectivity capabilities – CCHD screening guided by Eve is even more streamlined and efficient: one pulse oximetry sensor can be connected to Root via Radical-7, and a second via the MOC-9 module, allowing for the pre- and post-ductal SpO2 readings needed for screening to be taken simultaneously rather than sequentially, with results conveniently displayed on one screen. This Dual SET Oximetry technique streamlines the CCHD screening process, improving clinical workflows. Gerard R. Martin, MD, C.R. Beyda Professor of Cardiology at Children’s National Hospital, said, “As an advocate for congenital heart disease efforts nationally and internationally, I believe Masimo SET pulse oximetry is an excellent tool for pulse oximetry CCHD screening. Having access to accurate simultaneous pre-ductal and post-ductal measurements helps simplify the process of screening and allows for rapid recognition of discrepancies, ultimately improving newborn care.” Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide centralized, multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with numerous measurements in addition to dual oximetry Masimo SET, such as advanced rainbow Pulse CO-Oximetry measurements, O3 regional oximetry, and SedLine brain function monitoring, for expanded visibility of patient status. Using Root in combination with the Hospital Automation platform, monitoring data from all connected devices can be automatically charted in EMRs. Augusto Sola, MD, Vice President of Medical Affairs at Masimo, commented, “As a neonatologist who has worked nationally and internationally in the early diagnosis and treatment of hypoxemic and hyperoxemic conditions that affect neonates in order to improve neonatal survival and quality of life for these fragile infants, I know that Masimo SET measure-through motion technology’s accuracy and reliability have not only enabled CCHD screening with pulse oximetry, but have helped dramatically reduce retinopathy of prematurity (ROP). SET provides reliable, high-quality monitoring to prevent serious long-term morbidities and is now the standard of care for CCHD newborn screenings and ROP. With the availability of the SET MOC-9 Module, clinicians can now obtain simultaneous, dual oximetry pre- and post- ductal measurements, using one display, and increase efficiency of CCHD newborn screenings with Root. Furthermore, the Eve application on Root is automated and therefore simplifies and systematizes the screening process. Millions of newborn babies and their families throughout the world will be greatly benefited by this unique solution.”

NDD Welcomes Michael Bencak as New CEO

OCT 21 2021

NDD Medical Technologies (NDD), a global leader and innovator of diagnostic devices for the early detection of COPD and other chronic lung diseases, announced the appointment of Michael Bencak as Chief Executive Officer. Michael has two decades of experience in the medical device and biotechnology industry, including most recently at BEKA Scientific GmbH and Zinsser Analytic GmbH as Chief Executive Officer, where he repeatedly produced sustained revenue and Earnings Before Interest and Taxes (EBIT) growth in dynamic and evolving markets. Michael joins NDD at an exciting time, with the company exhibiting rapid growth due to the increasing demand for spirometry and DLCO devices. NDD was founded by Professor Karl Harnoncourt and Dr. Christian Buess, now Chief Technology Officer, after identifying an urgent need for advancements in pulmonary testing. With consistent growth throughout their 25-year history, NDD is the global leader in lung function testing and pulmonary function test devices, with innovative devices such as the EasyOne® product line providing much-needed point-of-care solutions. Committed to improving the lives of patients with the early detection and diagnosis of COPD and other chronic lung diseases, at a time of accelerating demand for additional lung testing due to long-Covid, NDD prides itself on the development of new and innovative solutions. Former CEO and now Chief Strategy Officer, Georg Harnoncourt, said “NDD has provided innovative lung function testing devices since 1996, with the mission of helping physicians around the world to rapidly identify and diagnose respiratory disease. We are excited to welcome Michael to the NDD family. His exemplary leadership track record, a wealth of medical technology experience and proven ability to drive results, makes him the right leader to build on NDD’s heritage and steer our future development at this pivotal time of expanding innovation.” Commenting on his new appointment as CEO, Michael Bencak says “I am delighted to join NDD. The business has a fantastic team and I feel honored to be able to build on the great foundations and innovative culture fostered by Georg and Christian. I am committed to the core values of our company and look forward to working closely with our exceptional team to accelerate innovation at this critical phase. Though global healthcare has always focused on the problem of emerging infections, the last 18 months have demonstrated that companies like NDD, who strive to not only be proactive but also reactive, are crucial to help build a better, more patient-oriented world.”

Life Supporting Ventilator with High-Flow Oxygen Therapy Gets Commercial Launch

OCT 12 2021

Movair, a respiratory therapy company formerly known as International Biophysics Corporation, announced the US commercial launch of Luisa, an advanced ventilator intended for use in homes, institutions, hospitals or portable applications for both invasive and non-invasive ventilation. Luisa can be used through the FDA's Emergency Use Authorization* in response to the increasing need for safe and effective ventilators. Luisa is a portable and compact home ventilator now available in the US and one of the first with the added benefit of high-flow oxygen therapy. For patients with chronic and acute respiratory conditions that require long-term ventilation, prolonged compliance is critical. Luisa was designed to help patients embrace everyday experiences and active, mobile lifestyles. Weighing only eight pounds, Luisa includes a battery run time of up to 18 hours and offers patients eight adjustable comfort settings to deliver personalized, tailored therapy. Luisa also features a rotatable 10-inch display and flexible connectivity options so patients can integrate the ventilator into current lifestyle habits such as sleeping on a certain side of the bed. Additionally, Luisa can be programmed in multiple languages, ensuring a multitude of diverse patients, families and caregivers receive understandable alarm notifications. "Life supporting ventilation with high-flow therapy using the Luisa device proved to be a true asset during the most recent COVID-19 surge," said Rami Arfoosh, MD, FCCP, Pulmonary and Critical Care Specialist and Associate Professor of Medicine at Medical College of Georgia, AU/UGA Medical Partnership. "It provided a new option to meet the high-flow needs for some patients in their home environment. Those patients would have otherwise continued to occupy hospital beds because of the lack of equipment that meets their needs at home. Luisa also provides the unique feature of switching back and forth between high-flow nasal cannula (HFNC) and non-invasive ventilator (NIV) with different mode by the push of a button." Luisa provides respiratory support and utilizes all standard volume, pressure and mouthpiece ventilation modes with the added benefit of high-flow oxygen therapy that can support nocturnally ventilated patients during the day with a less intrusive nasal cannula. High-flow oxygen therapy delivers a blend of air and oxygen that meets or exceeds a patient's inspiratory flow demand to improve oxygenation and decrease the workload of breathing. "Increased respiratory patient illness, COVID-19 and product recalls have created a critical need for ventilators in the United States," said David Shockley, CEO of Movair. "We're addressing this demand with the launch of Luisa, a portable and compact home ventilator, designed and made in Germany that also provides patients with high-flow oxygen therapy. At Movair, we're committed to advancing life-empowering respiratory therapies that help patients breathe better and live better. The launch of Luisa underscores this commitment." Luisa is the third-generation ventilator developed and manufactured by Lowenstein Medical in Germany, and marketed in Europe since 2020. It can be prescribed to patients diagnosed with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) dependent on meeting certain qualifications. Luisa can provide high-flow therapy to patients that need at-home ventilation and also offers FIO₂ and SPO₂ monitoring and ventilation from 100 ml VT. Movair is the exclusive US dealer for Lowenstein Medical. While Luisa can be purchased through various durable medical equipment (DME) providers, normally it is provided to patients by these DMEs through private or government health insurance. In August, Movair began pre-marketing Luisa, which is already being used by thousands of patients in the US. Many of these patients are recovering post-COVID and were transitioned home with Luisa.

New Non-invasive Ventilator Launched

OCT 12 2021

To meet the need for safe, effective and reliable non-invasive ventilation (NIV) throughout the care continuum, Dräger has launched the new Savina 300 NIV, the latest ventilator in its Savina 300 family of ventilators. Built to Dräger’s exceptionally high standards and backed by its 100+ years of experience in mechanical ventilation, the Savina 300 NIV features automatic leakage compensation to deliver consistent prescribed settings when faced with patient interface leaks. Its built-in turbine with rapid response time and external battery allows operation independent from the central gas supply to facilitate care continuity during patient transfers. “Both acute and alternative care facilities rely on Dräger for the latest innovations in respiratory care delivered with integrity and dependability,” said Steve Menet, Dräger’s senior vice president of sales, hospital solutions. “Breathing is essential to life so for patients with respiratory challenges any disruptions in the effectiveness of non-invasive ventilation can jeopardize outcomes. With the launch of Savina 300 NIV, we are meeting clinician and patient demand for consistent and safe non-invasive mechanical ventilation in both acute and chronic care facilities.” To help support patient comfort during NIV therapy, the Savina 300 NIV is compatible for use with the FitStar disposable mask, which features gel cushion technology to help reduce complications such as pressure points and skin irritation. Available in four sizes, FitStar’s simple and breatheable headgear has a continuous range of adjustment to offer a custom fit while removing pressure from the bridge of the nose. The mask’s 360 degree rotating elbow facilitates optimal tube positioning and ease of mobility, while its quick-release headgear slides off easily with one hand.

Company Appoints New President

Oct 1 2021

3B Medical Inc, an innovative manufacturer and distributor of Sleep, Oxygen and Disinfection products announced the appointment of Tom Pontzius as President, 3B Medical, Inc. Tom has over 35 years of experience in healthcare manufacturing and distribution. Tom most recently served as leader of Industry Affairs and Business Development at Philips where he was employed for over 12 years in various leadership roles. Throughout his career Tom has held various roles supporting various customers from hospitals and skilled nursing facilities to home health care and home medical equipment providers. Tom’s experience in sales, marketing, operations, manufacturing, and distribution will be critical as 3B Medical Inc. continues to grow and innovate in the healthcare and consumer health areas. “Tom’s leadership, knowledge of the industry and strategic thinking will allow 3B Medical to continue to grow and achieve its objectives.” said Alex Lucio, founder of 3B Medical. “His patient and customer first approach align well with 3B Medical’s mission. Adding valuable knowledge around the chronic diseases and treatment along with his proven ability to build scale allows 3B Medical to continue to build on its fast-growing businesses. We look forward to Tom’s leadership in continuing to build a world-class organization.” “3B Medical has been a leading company in the industry and continues to innovate and offer solutions to meet the demands of patients and providers,” said Pontzius.“ The proven products, the people at the company and the goals and objectives of the company align with my experience and skills. I look forward to building upon an already solid business with the executive leadership team and the dedicated associates at 3B Medical.”

New Ceiling Supply Units Add Flexibility in Hospitals

Sep 30 2021

Dräger’s new Ambia and Ponta ceiling supply systems offer hospitals substantial flexibility in creating customized workstations that supports specific clinical needs in the operating room (OR), intensive care unit (ICU) and neonatal intensive care unit (NICU). The ceiling supply systems provide the ability to mount medical equipment and accessories on all four sides of the frame rail. This optimizes space, and allows equipment and accessories to be placed exactly where they are needed. Free positioning of a mix of electrical and gas outlets on all panels make it possible to place more outlets on a media column or head. The result, Ambia helps streamline workflow with the goal of increasing the satisfaction and safety of staff and patients – now and in the future. And with coordinated frame color selections and drawer decor variants, Ambia and Ponta can be easily integrated into any room concept, creating a patient-friendly environment. In addition, lighting options featuring warm, glare-free light, along with the ability to select from a range of RGB colors, helping to contribute to a calming and soothing atmosphere. Ambia and Ponta feature intuitive user interfaces that support quick and easy operation. The arm brake handles feature touch-sensitive sensors that automatically release the brakes, allowing rapid positioning of the media heads or columns. The brake handle locations on the units can also be adapted to suit individual staff or workflow requirements for ideal ergonomics. The handles communicate using wireless technology, allowing them to be located almost anywhere on the system. For infection protection, rounded profiles and smooth materials that are compatible with a wide range of disinfection products help make the Ambia and Ponta easy and fast to clean and disinfect. A range of cable management options help eliminate cord clutter and assist with reducing exposed surface area and the accumulation of dirt. A touchless user control for operating ceiling and floor lights further supports infection prevention efforts. Dräger has more than 60 years of consulting experience in the design of medical workplaces, including the analysis of work processes and space requirements, consulting for optimized workflows and digitally supported room concept creation, and on-site equipment implementation.

Free Webinar: Challenges of Medication Applications

Sep 29 2021

Vitalograph (USA) Inc. is sponsoring another “Lunch and Learn webinar series” Challenges of Medication Application. This webinar is for health care providers, respiratory therapists, asthma educators, and nurses: Join in on Wednesday, Oct. 13, 2021, at 12:00 p.m. CDST, presented by Lorene Alba, AE-C, Director of Education for Asthma and Allergy Foundation of America. The goal of this program is to help you understand: How to properly use asthma devices; how to determine the best asthma delivery device; how to incorporate health literacy into all your resources; how to use the teach-back method. This program is pending for 1.0 contact hours of Continuing Respiratory Care Education (CRCE) credits by the American Association for Respiratory Care. Register here-

Medical Tech Company Buys Afflovest

Sep 29 2021

Tactile Systems Technology, Inc., a medical technology company focused on developing medical devices for the treatment of underserved chronic diseases at home, announced it has acquired the assets of the AffloVest respiratory therapy business from International Biophysics Corporation, a privately-held company which developed and manufactures AffloVest. AffloVest is a portable, wearable vest that treats patients with chronic respiratory conditions such as COPD-associated breathing conditions like bronchiectasis, or conditions resulting from neuromuscular disorders and cystic fibrosis, by managing airway clearance. AffloVest is the first truly portable, battery-powered, High Frequency Chest Wall Oscillation (HFCWO) device. Its use has been shown to reduce antibiotic use, emergency room visits and hospitalizations. “The addition of AffloVest represents an ideal strategic fit for Tactile Medical as it aligns well with our focus of treating patients with underserved chronic conditions in the home,” said Dan Reuvers, President and CEO of Tactile Medical. “We expect to promote AffloVest’s patented, portable design, demonstrated clinical outcomes, and established reimbursement within the Durable Medical Equipment (DME) channel to drive AffloVest to contribute to our overall company goal of 20%+ revenue growth going forward. Like lymphedema, the chronic pulmonary disease market represents a large, and still underpenetrated opportunity. Importantly, multiple members of our management team have significant experience in this category, which gives us confidence in our ability to execute our commercial strategy for AffloVest. We look forward to welcoming the AffloVest sales team to Tactile Medical and intend to maintain their strategy of partnering with DME companies to promote the proven therapy. The sales representatives at these DME companies are uniquely positioned to provide valuable access to chronic respiratory providers and patients through their complementary product and service offerings such as oxygen, nebulizers and ventilators.” Reuvers continued, “Longer term, we believe adding a mobile, wearable therapy to our portfolio invites synergy within our R&D roadmap as we advance our goals within ease-of-use and digital engagement. We believe this is a compelling transaction as it expands Tactile Medical’s annual addressable market opportunity in the U.S. to more than $10 billion, fits our long-term revenue and margin growth profile, enhances our long-term profitability, and is expected to generate an attractive return on investment.” Tactile Medical has financed the transaction through a combination of cash on hand and $55 million of borrowings under its existing credit facility, which is being amended in connection with this transaction. The credit facility is being exclusively provided by Wells Fargo Bank, NA. Tactile Medical expects its net leverage ratio as of year-end 2021 to be approximately 1.4x and anticipates its net leverage ratio as of year-end 2022 to be less than 1.0x.

CDC Says COVID, Flu Vaccines Can Be Co-Administered

Sep 27 2021

When the Centers for Disease Control and Prevention (CDC) released its latest round of recommendations regarding seasonal influenza vaccines, the document contained one notable update: flu vaccines and COVID-19 vaccines can now be given simultaneously. This change stands in marked contrast to previous recommendations, in which the CDC said that other vaccinations should not be administered within a 2-week window before or after receiving the COVID-19 vaccine. "We believe flu vaccination is very important in the context of ongoing COVID-19 activity," said Lisa A. Grohskopf, MD, MPH, medical officer, Influenza Division, CDC, in an interview. "First, as COVID-19 cases continue to increase, our healthcare system is increasingly burdened by caring for COVID-19 patients. While flu activity has been unusually low since March of 2020, we are seeing the return of other common respiratory viruses, so we anticipate that we will experience an annual epidemic of flu this season as we do during most winters. "Substantial flu activity occurring at the same time as COVID-19 activity could overwhelm our healthcare systems," she added. Grohskopf explained that the current recommendations ― the product of regular meetings of the Advisory Committee on Immunization Practices' (ACIP's) Influenza Working Group — are intended to guide clinicians in the use of influenza vaccines for the upcoming flu season, from late fall through early spring. Not surprisingly, they recommend routine annual influenza vaccination for all people who are at least 6 months of age and who do not have contraindications. Following such precautions will not only reduce the prevalence of illness caused by influenza but will also reduce symptoms that might be confused with those of COVID-19, the authors say. In addition, preventing flu and mitigating the severity of its symptoms will likely result in a reduction of outpatient visits, hospitalizations, and intensive care unit admissions, which in turn may alleviate stresses on the healthcare system caused by COVID-19. "ACIP and CDC's universal flu vaccine recommendation has not changed," Grohskopf noted. "Everyone 6 months of age and older should get a flu vaccine every season, with rare exception. There are some groups of people who are at higher risk of developing severe flu complications, and vaccination is especially important for them. This includes adults 65 years and older, people with certain chronic health conditions (for example, asthma, diabetes, heart disease), pregnant people, and children younger than 5 years old." In addition to the timing of COVID-19 vaccinations, the recommendations have other notable updates. First, the composition of flu vaccines has been updated such that all vaccines are now quadrivalent, designed to protect against four flu viruses. Additionally, licensure for the Flucelvax Quadrivalent flu vaccine has changed: the approved age indication for the cell culture–based inactivated vaccine has been increased from age 4 years or older to age 2 years or older.

Circadian System Implicated in Asthma Worsening at Night

Sep 27 2021

For hundreds of years, people have observed that asthma severity often worsens in the nighttime. One longstanding question has been to what degree the body's internal circadian clock -- as opposed to behaviors, such as sleep and physical activities -- contributes to worsening of asthma severity. Using two circadian protocols, investigators from Brigham and Women's Hospital and Oregon Health & Science University have pinned down the influence of the circadian system, uncovering a key role for the biological clock in asthma. Understanding the mechanisms that influence asthma severity could have important implications for both studying and treating asthma. Results are published in The Proceedings of the National Academy of Sciences. "This is one of the first studies to carefully isolate the influence of the circadian system from the other factors that are behavioral and environmental, including sleep," said co-corresponding author Frank A.J.L. Scheer, PhD, MSc, director of the Medical Chronobiology Program in the Division of Sleep and Circadian Disorders at the Brigham. Co-corresponding author Steven A. Shea, PhD, professor and director at Oregon Institute of Occupational Health Sciences added, "We observed that those people who have the worst asthma in general are the ones who suffer from the greatest circadian-induced drops in pulmonary function at night, and also had the greatest changes induced by behaviors, including sleep. We also found that these results are clinically important because, when studied in the laboratory, symptom-driven bronchodilator inhaler use was as much as four times more often during the circadian night than during the day." As many as 75 percent of people with asthma -- 20 million people in the U.S. -- report experiencing worsening asthma severity at night. Many behavioral and environmental factors, including exercise, air temperature, posture, and sleep environment, are known to influence asthma severity. Scheer, Shea, and colleagues wanted to understand the contributions of the internal circadian system to this problem. The circadian system is composed of a central pacemaker in the brain (the suprachiasmatic nucleus) and "clocks" throughout the body and is critical for the coordination of bodily functions and to anticipate the daily cycling environmental and behavioral demands. To disentangle the influence of the circadian system from that of sleep and other behavioral and environmental factors, the researchers enrolled 17 participants with asthma (who were not talking steroid medication, but who did use bronchodilator inhalers whenever they felt asthma symptoms were worsening) into two complementary laboratory protocols where lung function, asthma symptoms and bronchodilator use were continuously assessed. In the "constant routine" protocol, participants spent 38 hours continuously awake, in a constant posture, and under dim light conditions, with identical snacks every two hours. In the "forced desynchrony" protocol, participants were placed on a recurring 28-hour sleep/wake cycle for a week under dim light conditions, with all behaviors scheduled evenly across the cycle.

Company Expands Facility

Sep 27 2021

Siemens Healthineers announced it will invest more than $32 million in its Glasgow Laboratory Diagnostics Manufacturing Facility located in Newark, Delaware. The investment extends over 24 months and will enable the company to position in Delaware manufacturing capabilities for more than 20 diagnostic tests. This project is part of an initiative to drive greater efficiency, productivity, and stability across the company's diagnostics supply chain. “The Glasgow manufacturing facility expansion will further increase our manufacturing footprint in the United States—the largest healthcare market in the world,” said Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers. “As part of the expansion, we will relocate important test manufacturing to this facility, which will streamline some of our processes and further improve the efficiency with which we can deliver these important tests to healthcare providers and their patients.” The Newark, DE facility employs more than 1,300 employees and manufactures more than 120 assays that run on certain instrument platforms, including the Atellica Solution, ADVIA Chemistry, Dimension, Dimension Vista, Syva Drug Testing, and Stratus CS instruments—providing tests that help physicians diagnose, monitor, and/or treat diseases. The Glasgow manufacturing facility is one of several manufacturing facilities Siemens Healthineers operates for its diagnostics portfolio.

New Study Evaluates the Feasibility of Using Masimo EMMA Capnography on Mechanically Ventilated Neonates

Sep 27 2021

Masimo announced the findings of a study published in the European Journal of Pediatrics in which Dr. Masashi Hotta and colleagues at the Osaka Women’s and Children’s Hospital in Japan found that the Masimo EMMA Portable Capnograph “may be considered an effective monitoring device” for mechanically ventilated preterm infants (neonates). Noting the importance of maintaining an appropriate range of partial pressure of arterial carbon dioxide (PaCO2) in preterm infants, especially while undergoing mechanical ventilation in the neonatal intensive care unit (NICU), the researchers sought to evaluate whether noninvasively monitoring end-tidal carbon dioxide (EtCO2) with EMMA could help clinicians maintain neonatal PaCO2 in the delivery room. They chose EMMA not only because of its portability but because it offers a solution with a small dead space (1 mL). The researchers enrolled 40 neonates (gestational age of 26+0 to 31+6 weeks) who required intubation in the delivery room (the EMMA monitoring group) and compared their PaCO2 value, either at admission to the NICU or 2 hours after birth, with that of 43 infants who did not undergo EMMA monitoring (the historical control group). They defined “appropriate” PaCO2 as 35 – 60 mmHg, as measured using a blood gas analyzer. The researchers found that the proportion of infants with appropriate PaCO2 was greater in the EMMA group than in the control group (80% vs. 42%, p = 0.001). Stratified according to birth weight (< 1000 g vs. > 1000 g), they found that in smaller neonates, there was no significant difference in the proportion of infants with appropriate PaCO2 between groups, but in the larger cohort, the rate of appropriate PaCO2 was significantly higher in the EMMA group: 93% vs. 44%, p < 0.001. The study authors concluded that EMMA “facilitated the maintenance of an appropriate PaCO2 for mechanically ventilated pre-term infants, especially infants with birth weight ≥ 1000 g, in the delivery room.” They noted that the main strength of their study was that they “collected intervention data prospectively and showed the feasibility of using a portable capnometer during resuscitation of intubated preterm infants” – the first study of its kind. EMMA provides seamless mainstream capnography for patients of all ages in a compact, easily portable device. The instrument requires no routine calibration and minimal warm-up time, with accurate EtCO2 and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds.

Masimo CEO Joe Kiani Appointed to President’s Council of Advisors on Science and Technology

Sep 22 2021

Masimo announced that Founder, Chairman, and CEO Joe Kiani has been appointed by President Joe Biden to the President’s Council of Advisors on Science and Technology (PCAST). Since 1933, with the creation by President Franklin D. Roosevelt of a Science Advisory Board, each President has established an advisory committee of scientists, engineers, and health professionals. Created by Executive Order, President Biden’s PCAST will advise him on matters involving science, technology, education, and innovation policy. The Council also provides the President with scientific and technical information needed to inform public policy relating to the American economy, the American worker, national and homeland security, and more. In particular, President Biden has asked PCAST to consider such pressing topics as how the pandemic can inform public health needs and how scientific and technological breakthroughs can help address climate change. The 30 members of the Council, the most diverse in history, include distinguished individuals from sectors outside the Federal Government with diverse perspectives and expertise in science, technology, education, and innovation, including 20 elected members of the National Academies of Sciences, Engineering and Medicine, five MacArthur “Genius” Fellows, two former Cabinet secretaries, and two Nobel laureates. Joe Kiani commented, “Thank you, President Biden, for this appointment. I am excited to work with this incredible PCAST group and others to explore ways that science and technology, and policies that can shape them, can improve healthcare, the environment, innovation, and equity in our country and the world.”

Patients With More Severe PH in COPD May Respond to Treatment

Sep 15 2021

Patients with pulmonary hypertension (PH) as a complication of chronic obstructive pulmonary disease (COPD) have worse functional impairment and higher mortality, compared with patients who have idiopathic pulmonary arterial hypertension (IPAH). Despite these factors, some patients with more severe PH in COPD may respond to treatment and show clinical improvement after treatment, according to recent research published in the journal CHEST Carmine Dario Vizza, MD, of the pulmonary hypertension unit, department of cardiovascular and respiratory diseases at Sapienza University of Rome, and colleagues evaluated patients in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) database, enrolled up to August 2020, identifying 68 patients with moderate PH and COPD and 307 patients with severe PH and COPD. The researchers compared the PH and COPD groups with 307 patients who had idiopathic pulmonary arterial hypertension. Overall, mostly older men made up the group of patients with moderate (50%; mean, 68.5 years) and severe PH in COPD (61%; mean 68.4 years), compared with those who had IPAH (37%; mean 61.7 years. Oral monotherapy for patients with PH and COPD was the main treatment, consisting of phosphodiesterase-5 inhibitors, while most patients with IPAH received endothelin receptor antagonists. On functional tests, patients in the PH and COPD group tended to perform poorer on the 6-minute walking distance (6MWD) and World Health Organization functional class (WHO FC) than patients with IPAH. Specifically, among 42.7% of patients in both group for whom follow-up data were available, there was a similar frequency of improvement for 6MWD of 30 meters or more from baseline for both PH and COPD and IPAH groups (46.9% vs. 52.6%; P = .294), but there were significant differences between 6MWD between patients with moderate and severe PH and COPD (51.6% vs. 31.6%; P = .04). There was a nonsignificant improvement in WHO FC improvement of one or more classes for 65.6% of patients with PH and COPD and 58.3% of patients with IPAH with follow-up data available, with 28.5% of patients with PH in COPD improving compared with 35.8% of patients with IPAH (P = .078) and nonsignificant differences between moderate and severe PH and COPD (19.0% vs. 30.4%; P = .188). Follow-up data were available for 84% of patients with IPAH and 94% of patients with PH and COPD. Dr. Dario Vizza and colleagues found 45.7% of patients in the PH and COPD group and 24.9% of patients in the IPAH group died during follow-up, while 1.1% in the PH and COPD group and 1.5% of patients in the IPAH group underwent lung transplantations. For patients with moderate PH and COPD, 31.3% died and none underwent lung transplantation, while 49.0% of patients in the severe PH and COPD group died and 1.4% underwent lung transplantations.

Obese Children With Asthma Are Resistant to ICS

Sep 15 2021

Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest. Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma. They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal. “In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress. The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization. “While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said. Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results. In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score. The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.

Courageous RT Stories Told on Podcast

Sep 1 2021

Vitalograph (USA) Inc. has created a series of special editions for their Exhale podcast focused on the front lines of the great pandemic. The next several episodes we will be titled “Ask the Respiratory Therapist.” This special series will interview multiple Respiratory Therapists and PFT technicians in different healthcare situations caring for COVID-19 infected patients. They share their experiences with the public, what they endured during this pandemic, and what they expect of the future. The host of Exhale is Mark Russell, Marketing Communications Manager and Janson Lanier, National Sales Manager and Respiratory Therapist for Vitalograph US, a global leader in respiratory diagnostics. The most recent interview is with Kimberly Wins Koldoff a Respiratory Therapist working at a Medical Center outside of Atlanta, Georgia. Exhale connected with her when she posted on LinkedIn an emotional cry after a long shift and a plea to get vaccinated. Here’s her message: “My shifts this weekend confirmed my fears…Covid is indeed back. Today was one of the most exhausting days I’ve ever worked. I’m grieving. I’m angry. I’m scared. I’m tired. What can we do? Please consider getting vaccinated if you haven’t already.” These interviews of Respiratory Therapists and their colleagues on the frontlines say a lot about the pressure and the courage of the past 18 months. The days have been long, the breaks have been few, and the urgency has been unrelenting. The intent of these interviews is to shed some light of these medical heroes and what they endure day after day during the COVID pandemic. Vitalograph is a world-leading provider of the highest quality respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning over half a century, Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.

Long COVID Symptoms Can Persist for More Than 1 Year, Study Shows

Aug 30 2021

Nearly one half of people who are hospitalized with COVID-19 suffer at least one lingering symptom 1 year after discharge, according to the largest study yet to assess the dynamic recovery of a group of COVID-19 survivors 12 months after the illness. The most common lingering symptoms are fatigue and muscle weakness. One third continue to have shortness of breath. Overall, at 12 months, COVID-19 survivors had more problems with mobility, pain or discomfort, and anxiety or depression, and had lower self-assessment scores of quality of life than matched COVID-free peers, the investigators report. The study was published online August 26 in The Lancet.

"While most had made a good recovery, health problems persisted in some patients, especially those who had been critically ill during their hospital stay," Bin Cao, MD, from the National Center for Respiratory Medicine at the China-Japan Friendship Hospital and Capital Medical University, both in Beijing, said in a Lancet news release.

"Our findings suggest that recovery for some patients will take longer than one year, and this should be taken into account when planning delivery of healthcare services post-pandemic," Cao said.

Antidepressant Helps Prevent Hospitalization in COVID Patients: Study

Aug 30 2021

A handful of studies have suggested that for newly infected COVID-19 patients, risk for serious illness may be reduced with a short course of fluvoxamine (Luvox), a decades-old pill typically prescribed for depression or obsessive-compulsive disorder (OCD). But those were small studies involving just a few hundred people. Researchers reported promising data from a large, randomized phase 3 trial that enrolled COVID-19 patients from 11 sites in Brazil. In this study, in which 1472 people were assigned to receive either a 10-day course of fluvoxamine or placebo pills, the antidepressant cut emergency department and hospital admissions by 29%. Findings from the new study, which have not yet been peer reviewed, were published August 23 in MedRxiv. Around the globe, particularly in countries without access to vaccines, "treatment options that are cheap and available and supported by good-quality evidence are the only hope we've got to reduce mortality within high-risk populations," said Edward Mills, PhD, professor in the Department of Health Research Methods, Evidence and Impact, McMaster University, Ontario, Canada.

The new findings came from TOGETHER, a large platform trial coordinated by Mills and colleagues to evaluate the use of fluvoxamine and other repurposed drug candidates for symptomatic, high-risk, adult outpatients with confirmed cases of COVID-19. The trial's adaptive format allows multiple agents to be added and tested alongside placebo in a single master protocol — similar to the United Kingdom's Recovery trial, which found that the common steroid dexamethasone could reduce deaths among hospitalized COVID-19 patients. In platform trials, treatment arms can be dropped for futility, as was the case with hydroxychloroquine and lopinavir-ritonavir, neither of which did better than placebo at preventing hospitalization in an earlier TOGETHER trial analysis.

Children's Upper Airways Primed to Combat SARS-CoV-2 Infection

Aug 30 2021

Epithelial and immune cells of the upper airways of children are pre-activated and primed to detect a COVID-19 infection, which may contribute to a stronger early immune responses to a COVID infection than in adults, new research suggests. The findings may help to explain why children have a lower risk of developing severe COVID-19 illness or becoming infected with SARS-CoV-2, the novel coronavirus, in the first place, the researchers say. The study was published online August 18 in Nature Biotechnology Children appear to be better able than adults to control SARS-CoV-2 infection, but, until now, the exact molecular mechanisms for this have been unclear. A team of investigators from Germany did an in-depth analysis of nasal swab samples obtained from 24 children and 21 adults who tested positive for SARS-CoV-2, as well as a control group of 18 children and 23 adults who tested negative for SARS-CoV-2. “We wanted to understand why viral defense appears to work so much better in children than in adults,” Irina Lehmann, PhD, head of the molecular epidemiology unit at the Berlin Institute of Health Charité – Universitätsmedizin Berlin, explains in a news release. Single-cell sequencing showed that children had higher baseline levels of certain RNA-sensing receptors that are relevant to SARS-CoV-2 detection, such as MDA5 and RIG-I, in the epithelial and immune cells of their noses. This differential expression led to stronger early immune responses to SARS-CoV-2 infection in children than in adults. Children were also more likely than adults to possess distinct immune cell subpopulations, including KLRC1+ cytotoxic T cells, involved in fighting infection, and memory CD8+ T cells, associated with the development of long-lasting immunity. The study provides “clear evidence” that upper airway immune cells of children are “primed for virus sensing, resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults,” the investigators say. Primed virus sensing and a pre-activated innate immune response in children leads to efficient early production of interferons (IFNs) in the infected airways, likely mediating substantial antiviral effects, they note. Ultimately, this may lead to lower viral replication and faster clearance in children. In fact, several studies have already shown that children do eliminate the virus quicker than adults, consistent with the concept that they shut down viral replication earlier, the study team says.

EAACI Review Urges Reduction in Antibiotic Overuse With Allergy

Aug 30 2021

Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease. Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis. The review, by lead author Gerdien Tramper-Stranders, MD, PhD, Department of Pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online August 13 in the journal Allergy. The authors note that several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases. In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit. "In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking," the authors write. Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Tramper-Stranders told Medscape Medical News. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.

Patients With More Severe PH in COPD May Respond to Treatment

Aug 30 2021

Patients with pulmonary hypertension (PH) as a complication of chronic obstructive pulmonary disease (COPD) have worse functional impairment and higher mortality, compared with patients who have idiopathic pulmonary arterial hypertension (IPAH). Despite these factors, some patients with more severe PH in COPD may respond to treatment and show clinical improvement after treatment, according to recent research published in the journal CHEST. Carmine Dario Vizza, MD, of the pulmonary hypertension unit, department of cardiovascular and respiratory diseases at Sapienza University of Rome, and colleagues evaluated patients in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) database, enrolled up to August 2020, identifying 68 patients with moderate PH and COPD and 307 patients with severe PH and COPD. The researchers compared the PH and COPD groups with 307 patients who had idiopathic pulmonary arterial hypertension. Overall, mostly older men made up the group of patients with moderate (50%; mean, 68.5 years) and severe PH in COPD (61%; mean 68.4 years), compared with those who had IPAH (37%; mean 61.7 years. Oral monotherapy for patients with PH and COPD was the main treatment, consisting of phosphodiesterase-5 inhibitors, while most patients with IPAH received endothelin receptor antagonists. On functional tests, patients in the PH and COPD group tended to perform poorer on the 6-minute walking distance (6MWD) and World Health Organization functional class (WHO FC) than patients with IPAH. Specifically, among 42.7% of patients in both group for whom follow-up data were available, there was a similar frequency of improvement for 6MWD of 30 meters or more from baseline for both PH and COPD and IPAH groups (46.9% vs. 52.6%; P = .294), but there were significant differences between 6MWD between patients with moderate and severe PH and COPD (51.6% vs. 31.6%; P = .04). There was a nonsignificant improvement in WHO FC improvement of one or more classes for 65.6% of patients with PH and COPD and 58.3% of patients with IPAH with follow-up data available, with 28.5% of patients with PH in COPD improving compared with 35.8% of patients with IPAH (P = .078) and nonsignificant differences between moderate and severe PH and COPD (19.0% vs. 30.4%; P = .188).

AHA Targets Rising Prevalence of Obstructive Sleep Apnea in Children

Aug 30 2021

Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association. The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese. The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association. Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented. “There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.” For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.” The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring. In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.” Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote. Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.

Vapotherm Announces FDA Clearance for HVT 2.0 Next Generation Platform

Aug 30 2021

Vapotherm, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next generation system is designed to provide high velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. hospital beds don’t have wall air. When paired with an oxygen source, the HVT 2.0 will support patients whether they need respiratory support in the hospital or home setting. The Company is planning a limited commercial release of HVT 2.0 in the United States in the fourth quarter of 2021. “Clearance of HVT 2.0 enables us to provide high velocity therapy to Patients throughout the hospital, which is very important when ICU beds become scarce. It will allow hospitals to leverage their general care floors and potentially reduce emergency room crowding and wait times. We will also use this next generation platform, combined with the Vapotherm Access digital remote Patient monitoring platform, to begin learning how to treat complex lung disease Patients in the home,” said Joe Army, President and CEO of Vapotherm. Vapotherm, Inc. is a publicly traded developer and manufacturer of advanced respiratory technology based in Exeter, New Hampshire, USA. The company develops innovative, comfortable, non-invasive technologies for respiratory support of patients with chronic or acute breathing disorders. Vapotherm is focused on the development and commercialization of its proprietary Vapotherm high velocity therapy® products which are used to treat patients of all ages suffering from respiratory distress. Over 3.0 million patients have been treated with the use of Vapotherm high velocity therapy systems. For more information, visit

Masimo SafetyNet Alert Launches in Western Europe

Aug 30 2021

Masimo announced the CE marking and launch in western Europe of Masimo SafetyNet Alert, an arterial blood oxygen saturation monitoring and alert system designed for use at home. Masimo SafetyNet Alert features Signal Extraction Technology wearable fingertip pulse oximetry sensor that communicates wirelessly to an accompanying Home Medical Hub and smartphone app. Masimo SafetyNet Alert monitors blood oxygen saturation (SpO2) and pulse rate (PR) using clinically proven Masimo SET Measure-through Motion and Low Perfusion pulse oximetry and perfusion index (Pi). The system provides escalating alerts when drops in oxygen levels are detected, designed to wake up the person suffering from opioid overdose and if they do not, to send alerts to others when help may be needed. Over 200 million people are monitored with Masimo SET pulse oximetry in hospitals each year. In hospitals, continuous Masimo SET oxygen saturation monitoring has been shown to reduce harm associated with opioids in multiple clinical trials, including a 10-year study in which researchers at Dartmouth-Hitchcock Medical Center found that the use of Masimo SET-based continuous patient surveillance monitoring resulted in zero opioid-related preventable deaths or brain damage in their post-surgical wards. The researchers also found there was a reduction in rapid rescue events by 60%, a reduction in ICU transfers by 50%, and an estimated $7 million annually in cost savings. Opioids are powerful painkillers, and are commonly used as part of recovery after surgery and for patients with chronic pain, but they can also slow or stop one’s breathing, potentially leading to heart attack, brain damage, and even death. In 2020 the number of drug-related deaths recorded in England and Wales rose to 4,561, the highest since records began, and around half of these involved opioids.5 Worldwide, that number is even worse, with an estimated more than 100,000 people dying from opioid overdose each year. Whether taking prescription or non-prescription opioids, people can suffer from the condition known as opioid-induced respiratory depression (OIRD) to varying degrees.6 Opioid overdose may occur while a person is particularly vulnerable, while asleep, and the risk of opioid overdose-related death is heightened for people taking opioids for the first time, those who have sleep apnea, COPD, or asthma, along with those who combine opioids with alcohol or other sedatives, amongst other factors. By monitoring a person’s oxygen saturation level, especially while asleep, and providing escalating alerts when help may be needed, Masimo SafetyNet Alert can help identify life-threatening opioid overdose before it causes lasting harm or even death. Masimo SafetyNet Alert leverages the same SET pulse oximetry technology and a similar notification escalation policy used in hospitals to bring hospital-proven monitoring to the home setting. The system provides escalating visual and audible alerts on the smartphone app and at the Home Medical Hub station, which are designed to alert the patient or anyone nearby to help prompt action. If oxygen levels continue to decline, designated emergency contacts, such as friends and family members, are also notified via text messages, so that they can intervene or involve Emergency Medical Services as needed. Masimo SafetyNet Alert brings to the home the breakthrough Masimo SET pulse oximetry used in hospitals around the world. SET has been clinically proven to help care teams enhance patient safety and improve patient outcomes; in fact, more than 100 independent and objective studies have shown that Masimo SET outperforms other pulse oximetry technologies during motion and low perfusion conditions, providing clinicians with increased sensitivity and specificity to make critical care decisions. Dr Mike Durkin, a Senior NHS Advisor on Patient Safety Policy and Leadership for the National Institute for Health Research (NIHR) Imperial College Patient Safety Translational Research Centre, said, “Patients recovering from surgery still need pain relief using opioid drugs after they are discharged from hospital and return home. However, these drugs have significant side-effects, particularly on the depression of breathing, which without urgent intervention can result in serious harm or death. The technology is now available to monitor the impact of opioids on breathing and it is vital that patients are given the opportunity to easily and continuously monitor their oxygen levels and vital signs while taking these medications at home. This will greatly improve the safety of patients while rehabilitating at home.” Yvonne Gardner, mother of 21-year-old Parker Stewart, who died of an opioid overdose after taking only half of the prescribed dose of painkillers following a tonsillectomy, said, “I’ve had so many people call me personally and say, what would you do differently? My son needs a tonsillectomy, or my daughter is going into surgery. I tell them: make sure your doctor gives you a monitor.” Joe Kiani, Founder and CEO of Masimo, said, “30 years ago, we had the dream of improving patient outcomes and reducing the cost of care by taking noninvasive monitoring to new sites and applications. Bringing our measure-through motion and low perfusion pulse oximetry to the home to monitor patients taking opioids is fulfilling that dream in a way that I could not have imagined at the time. I hope tens of thousands of lives will be saved each year from opioid overdose with the launch of Masimo SafetyNet Alert.”

Study Shows Positive PVi Results

Aug 23 2021

Masimo announced the findings of a study published in the Turkish Journal of Emergency Medicine in which Drs Seda Dağar and Hüseyin Uzunosmanoğlu at the Kecioren Training and Research Hospital in Ankara, Turkey investigated the role that noninvasive, continuous Masimo PVi might play in monitoring volume status and volume changes in spontaneously breathing patients undergoing hemodialysis (HD). The researchers found that there was a “strong correlation” between change in PVi and the volume of fluid removed, concluding that “PVi may provide clinicians with useful information for monitoring the volume status in critically ill patients with spontaneous breathing.” More than 100 independent studies have demonstrated the utility of PVi as an indicator of fluid responsiveness. Noting that PVi has been studied mostly in mechanically ventilated patients, the researchers sought to investigate its ability to help assess volume changes in spontaneously breathing patients. They enrolled 60 adult patients with end-stage renal disease who received routine HD (during which fluid is removed simultaneously with the removal of waste solutes) and had a median of 3,500 cc of fluid removed during HD. PVi was measured using a Masimo pulse oximetry sensor attached to a Masimo Root monitor, before and after HD, and changes in PVi were compared to the amount of fluid removed during the session. The researchers found that mean PVi showed a statistically significant increase after HD, from 20.7% ± 5% to 27.7% ± 6% (p < 0.001). Based on the amount of fluid removed during HD, the change in PVi was statistically significant (p = 0.015) and was strongly correlated to the volume of fluid removed (r = 0.744, p < 0.001). The researchers concluded, “In the present study, we found that the fluid removed by HD in spontaneously breathing patients caused an increase in PVi and that this increase was strongly correlated with the amount of volume change. Bedside monitoring of PVi, which is a noninvasive, fast, reproducible measurement parameter, may provide the clinicians with useful information for monitoring the volume status and evaluating the effectiveness of volume‑restoration therapy in critically ill patients with spontaneous breathing.” The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi. In the US, PVi is cleared as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients.

New Digital Features Available to Make Set Up Easier for Parents

Aug 17 2021

ResMed, a global leader in digital health and sleep apnea treatment, launched AirSense 11, available first in the US, the company’s next-generation PAP (positive airway pressure) device designed to help hundreds of millions of people worldwide with sleep apnea start and stay on therapy to treat and manage obstructive sleep apnea. AirSense 11 includes new features like Personal Therapy Assistant and Care Check-In designed to provide tailored guidance to PAP users, helping ease them into therapy and comfortable nightly use. Other features include the availability of remote software updates so users can enjoy the latest version of these tools every night. “AirSense 11’s new tailored features along with our myAir patient engagement app help give people the support they need to use PAP – the gold standard for treating sleep apnea – comfortably and confidently every night,” said Jim Hollingshead, ResMed president of Sleep and Respiratory Care. “And when digital health helps guide patients, it enables clinicians to provide great care to all their patients more efficiently.” AirSense 11 features include: Personal Therapy Assistant provides interactive step-by-step tutorials via the myAir app for patients to set up their device and acclimate to therapy pressure. Care Check-In gives patients tailored guidance through key milestones in their treatment journey, based on patients’ responses to simple questions like “How is your therapy” and “How sleepy did you feel this week?” It’s available in the myAir app and on the device screen itself. With the patient’s consent, healthcare providers can also see their patients’ responses in AirView, providing another fast, virtual way to monitor patients. A sleek design, touch screen, and intuitive menu mimic a smartphone, making it easy to use, designed to support increased adherence to therapy. ResMed’s proprietary therapy algorithms for AutoSet or APAP (auto-adjusting PAP) that delivers breath-by-breath therapy adjustments, the AutoSet for Her mode, a setting tailored to treat the female-specific characteristics of mild to moderate obstructive sleep apnea, and CPAP (continuous PAP). The ability to make over-the-air upgrades directly to a user’s device – just like you would get on a smartphone. AirSense 11 also gives access to myAir (patient engagement app) and AirView (remote monitoring platform for clinicians) – which together help bring overall patient adherence as high as 87%. The myAir app tracks the amount of time patients spend using CPAP therapy, number of sleep apnea events per hour, mask leak, and the number of times a mask was removed, providing nightly data on breathing, coaching tips, and support directly to their phone. AirView provides a secure, cloud-based patient management system for online patient monitoring that enables healthcare professionals to quickly access patient data, share clinical insights with other health professionals, improve care and reduce costs related to patient follow-up. AirSense 11 is available in the US, with other countries to follow, and is compatible with all ResMed masks. To learn more about AirSense 11, visit or speak with your healthcare provider.

Biologics for Asthma Also Improve Chronic Rhinosinusitis

Aug 13 2021

Biologics used as an asthma treatment also appear to improve symptoms of coexisting chronic rhinosinusitis in some patients, according to results from a real-world study published in the International Forum of Allergy & Rhinology. Although patients with asthma commonly have coexisting chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP), research on the effect of biologics has focused on CRSwNP, according to Devyani Lal, MD, of the Department of Otolaryngology, Division of Rhinology, Mayo Clinic, Phoenix, Arizona, and colleagues. The researchers evaluated how the use of omalizumab, mepolizumab, benralizumab, reslizumab, and dupilumab affected a group of 181 patients with asthma and CRSwNP and 66 patients with asthma and CRSsNP in a retrospective review of electronic health records at the Mayo Clinic. Over a period of at least 12 months, most patients in the study received omalizumab (51%), mepolizumab (46.6%), benralizumab (10.5%) or a combination of omalizumab and mepolizumab (6.9%). Of the 247 patients studied, 206 (84.1%) underwent endoscopic sinus surgery (ESS) and 189 of those patients had the surgery performed prior to receiving biologic therapy. Matched-pair analyses were performed to identify changes from baseline in Lund-Mackay CT scores, SNOT-22 scores, serum eosinophil counts, and serum immunoglobulin E (IgE) levels. Lal and colleagues found treatment with an anti-interleukin-5 (anti-IL-5) biologic such as mepolizumab, benralizumab, or reslizumab significantly improved Lund-Mackay CT scores when analyzing the proportion of patients with both CRSwNP and CRSsNP, and SNOT-22 scores for patients with CRS overall and CRSwNP. Patients who received the anti-IgE biologic omalizumab had improved Lund-Mackay CT scores, but SNOT-22 scores did not significantly improve at any follow-up time, including the longest follow-up at mean 23.7 months. Aaron N. Pearlman, MD, an otolaryngologist at Weill Cornell Medicine and NewYork-Presbyterian in New York City, said the finding of objective and subjective improvement in a real-world study is important. "It shows you that these monoclonal antibodies are having a positive effect on diffuse chronic inflammatory conditions," said Pearlman, was not involved in the study. "Where asthma and chronic sinusitis with nasal polyps in many patients have a similar inflammatory pathway, we think that these medications would work on both systems. With this retrospective data, they've shown that there is some improvement even in patients [where] the indicated use was not for nasal polyps."

New Solution to Impact the Future of Respiratory Simulation

Aug 4 2021

IngMar Medical, LLC, a leading global provider of respiratory simulation solutions, launched their next generation solution for respiratory and ventilation training, RespiPro. With RespiPro, educators can train all levels of learners across multiple disciplines on the full scope of respiratory techniques using their own real ventilators and respiratory devices. The solution includes the most realistic breathing simulator, the ASL 5000, as well as easy-to-use software, a true-to-life patient monitor, and a respiratory-focused manikin on a compact ICU bed. IngMar Medical President, Brian Linn, explains, “We have spent years talking to customers about how we can help them achieve better training outcomes, ultimately leading to better patient care. We understand that our customers want to immerse their learners in an environment that is indistinguishable from real life, while controlling the simulation with easy-to-use software. These are the key elements of our new RespiPro, and that is why we are thrilled to share it with respiratory educators all over the world.” While the concept of RespiPro is the same as IngMar Medical’s legacy RespiSim System solutions, this launch is particularly monumental due to the overhaul of both the software and hardware components. IngMar Medical worked closely with educators throughout the entire development process to ensure RespiPro meets their respiratory and ventilation training needs. “The launch of RespiPro marks a major step on our journey, and we couldn’t be more excited to continue working with the respiratory simulation community to build off of this new foundation,” stated Linn.

CPAP Device is Available for Acute Care Use and Surge Capacity Planning

Aug 3 2021

The FDA issued recent guidelines indicating that Bilevel and CPAP devices can be used to effectively help treat COVID-19 patients in Respiratory Distress potentially avoiding mechanical ventilation. The patented Flow-Safe II+ is the first and only Disposable Bilevel CPAP ventilatory assist device available in the global market. This disposable Bilevel CPAP system includes a mask and manometer and optional filter that provides hospital and emergency clinicians with the components required to quickly set up the device and connect to an oxygen source for delivering verifiable Bilevel and CPAP therapies to patients in respiratory distress. A recent article published in the American Journal of Emergency Medicine supports the use of the Flow-Safe product line concluding, “The Flow-Safe Disposable CPAP system can be as effective as NIMV in patients with Acute Cardiogenic Pulmonary Oedema (ACPO). Considering the overall improvement observed in the physiological blood gas and other parameters as well as the mortality and cost-related considerations, FSD-CPAP-S can be preferred in emergency services if there are insufficient NIMV devices.” The disposable advantage reduces the need for costly capital equipment and is the clinical solution for situations where backup Bilevel / CPAP equipment is scarce or unavailable. Flow-Safe II+ has been used extensively in pre-hospital EMS environments and in acute care emergency rooms. The disposable feature has the added advantage of assisting in preventing potential cross contamination. These advantages make it an ideal solution when planning surge capacity for pandemics or natural disasters. Flow-Safe II+ was introduced to the market in 2018 and has been awarded two prestigious industry awards, the 2018 EMS World Innovation Award and the 2019 JEMS Hot Products Award. This novel device was selected for both awards from over hundreds of submissions after a thorough review by panel of judges consisting of emergency medical services (EMS) product specialists, physicians, educators, managers and paramedics. The United States Patent and Trademark Office (USPTO) has issued Flow-Safe II+ US Patent No.10,258,759 in 2019. In March 2020, the USPTO issued two new utility patents, US Patent No. 10,583,266 and 10,583,262 for the award-winning Flow-Safe II+ Disposable Bilevel CPAP device. John Gargaro MD, President and CEO at Mercury Medical, states: “Mercury Medical believes that Flow-Safe II+ is a unique superior solution designed to quickly improve patients in respiratory distress with a cost-efficient device. The disposable feature assists in reducing hospital infection rates that are associated with reusable equipment, Mercury Medical has a rich experience in introducing innovative, clinically differentiated medical devices to market. We are extremely pleased to extend this device to the acute care market where there is a need for Disposable Bilevel CPAP equipment.”

Benralizumab Promising for Severe, Chronic Rhinosinusitis With Nasal Polyps

Jul 30 2021

Benralizumab (Fasenra) significantly reduced nasal polyp score (NPS) and average nasal blockage score (NBS) compared with placebo for patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) in a phase 3 trial. The randomized, multicenter, double-blind, placebo-controlled OSTRO study, sponsored by AstraZeneca, enrolled 413 patients in Europe and North America with severe CRSwNP. The patients generally had high rates of comorbid asthma (68%); prior NP surgeries (73%); and elevated Sino-Nasal Outcome Test (SNOT-22) scores. They were randomly assigned in a 1:1 ratio to receive either benralizumab 30 mg or placebo. NPS and NBS (scored by patients from 0 [no blockage] to 3) were co-primary endpoints. Improvements in both were statistically significant compared with placebo at week 40 (P < .005). Improvements were maintained through week 56 (P < .05). Results were presented on July 11 at the European Academy of Allergy and Clinical Immunology (EAACI) Meeting 2021 by principal investigator Claus Bachert, MD, PhD, head of the Department of Oto-Rhino-Laryngology and chair of the Upper Airway Research Laboratory, University Hospital Ghent, Ghent, Belgium. He said, "It's clear that there is a significant difference from placebo." On the NPS, the difference from placebo was -0.57 (P = .0001) from week 40 to week 56. On the NBS, the difference from placebo was -0.27 (P = .005) at week 40. Patients with CRSwNP typically endure sleep disruptions, nasal congestion, loss of smell, and rhinorrhea, which lower physical and mental health-related quality of life. Current pharmacologic therapies, including intranasal and systemic corticosteroids, are often inadequate for managing symptoms, and symptoms frequently recur after surgery, he said. In the OSTRO trial, enhanced treatment effects were seen in some groups, including patients with comorbid asthma and/or higher baseline blood eosinophil counts.

Short-Acting Beta Agonist Overuse 'a Global Public Health Issue'

Jul 30 2021

About one third of asthma patients have high use of short-acting beta agonists (SABAs) in Europe across all severity levels, said Santiago Quirce, MD, PhD, with Hospital Universitario in Madrid, Spain. High use — defined as three or more canisters dispensed per year — "is a global public health issue," and is associated with increased risk of asthma exacerbations and death, he said, along with increased healthcare costs. Asthma patients tend to rely too heavily on SABAs and too little on inhaled corticosteroids (ICS), he said Saturday at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021, adding that SABA use continues to increase globally. Quirce is a co-author on the SABINA study, the largest real-world study on SABA use. It included 1 million people with asthma across five European countries. Among the findings were that overuse varied greatly by country. Overuse was 9% in Italy; 16% in Germany; 29% in Spain; 30% in Sweden; and 38% in the United Kingdom. In the UK, SABA overuse was greater for people with moderate-to-severe asthma compared with those who had mild asthma (58% vs 27%, respectively.) Quirce also pointed to a 2012 study in the Annals of Allergy, Asthma & Immunology of more than 33,000 patients that identified values of SABA that predicted exacerbations in children in adults. For adults, "use of 2 or more SABA canisters was found as the critical value with shorter optimal assessment periods of 3 and 6 months," the 2012 study found. "Each additional SABA canister resulted in an 8% to 14%" increase in the risk for asthma-related exacerbation in children and "a 14% to 18%" increase in that risk in adults. Patients become overreliant on the SABA inhalers, which have been in use for more than 50 years, for many reasons, Quirce said, despite the increased risk of exacerbations.

How Intranasal COVID Vaccines Could Be 'Holy Grail' of Vaccination

Jul 30 2021

Beyond the obvious advantage for the needle-phobic, the seven intranasal COVID-19 vaccines in development could offer two additional layers of protection against SARS-CoV-2 infection, experts say. First, intranasal vaccines could produce antibodies and attract other components of the immune system to the nose and upper respiratory tract, forming a first line of defense against infection. Second, if infection does occur, a local response in the nose can be faster than a systemic one, giving SARS-CoV-2 less of a chance to replicate, shed, and be transmitted to others. At least that's the idea. "We'll see how they fare in clinical trials, but research suggests that these types of vaccines should trigger a specialized immune response in the nasal passages that can help stop SARS-CoV-2 at the site of infection and reduce transmission," Troy D. Randall, PhD, said. Randall and co-author Frances Lund, PhD, analyzed the promise of intranasal COVID-19 vaccines in a perspective article published online July 22 in Science. Applying the vaccine directly to the inside or mucosa of the nose could be an advantage, agreed Deborah H. Fuller, PhD. "Mucosal immunity, especially for respiratory diseases, is a relatively untapped gold mine for vaccines," she said when asked to comment. Recent research from Fuller and colleagues, as well as others, suggests that immune responses on the mucosa can limit viral replication better than immune responses localized in the blood. "And this makes sense. If you have immune cells localized at the initial site where the virus infects, it could shut down the virus before it gets a chance to replicate," added Fuller, professor of microbiology at the University of Washington School of Medicine and chief of the Division of Infectious Diseases and Translational Medicine at the Washington National Primate Research Center, Seattle, Washington.

COPD worsens COVID-19 by altering epithelial cell genes

Jul 30 2021

New findings shed light on why chronic obstructive pulmonary diseases increase patients’ risks for severe COVID-19. The diseases cause genetic changes in the epithelial cells that line the airways, making the cells more vulnerable to attack from the coronavirus, researchers reported in Nature Communications. Laboratory studies of these cells found changes in their molecular makeup that likely make it easier for the virus to enter the body, make copies of itself, and trigger out-of-control immune responses that fill the lungs with fluid and cause severe organ damage. The researchers, led by Nicholas Banovich at Translational Genomics Research Institute in Phoenix, were only able to examine cells from lung-disease patients without COVID-19 but said their “study highlights crucial areas for future research.”

An active lifestyle may reduce the risk of sleep apnea

Jul 30 2021

Getting off the couch and into activities that get your body moving is linked to a decreased risk of obstructive sleep apnea (OSA), according to a wide-scale study that highlights the hazards of leading a sedentary life. The study, published in the European Respiratory Journal, tracked around 130,000 men and women in the U.S. over a period of 10 to 18 years and found that more movement and less sedentary behaviour were associated with a lower likelihood of OSA. “In our study, higher levels of physical activity and fewer hours of TV watching and sitting either at work or away from home were associated with lower OSA incidence after accounting for potential confounders,” said Tianyi Huang, an associate epidemiologist at Brigham and Women’s Hospital, a teaching hospital affiliated with Harvard University. “Our results suggest that promoting an active lifestyle may have substantial benefits for both prevention and treatment of OSA.” A 2014 study estimated that around 5.4 million Canadians have either been diagnosed with sleep apnea or are at high risk of the disorder. OSA, the most common type of sleep apnea, occurs when the upper airways become blocked, often because the soft tissue at the back of the throat collapses and obstructs the flow of oxygen to the lungs. This passage can also become comprised in people with large tongues, relaxed throat muscles or narrow airways. Family members are usually aware of the issue before those with the actual disorder, largely because obstructed airways can result in loud snoring followed by choking or gasping for breath during sleep. Many of the symptoms of OSA are felt the next day, including a morning headache, fatigue, irritability or mood changes, poor concentration, memory loss or a lowered sex drive. Serious cases of OSA can increase the risk of heart issues, including heart failure. Researchers used statistical modelling to compare physical activity and sedentary hours to OSA diagnoses. Moderate and vigorous physical activity were looked at separately and both were found to be strongly tied a lower risk of OSA, with no real difference detected between the intensity of the activity. The correlation was strongest for women, adults over the age of 65 and those with a BMI greater or equal to 25 kg/m2.

Virtual Space Created for Clinicians

Jul 19 2021

Dale Medical Products, Inc. has created a virtual space to allow clinicians, patients and purchasing/value analysis professionals the opportunity to learn about Dale products in a simulated setting. When visiting the Virtual Dale Medical Center, users can enter rooms by specialty to see products that are available for clinicians and their patients. Users can move around the room to view product videos and other information relevant to each care setting, select product(s) on the patient which enables contextual information, view 3-D product renderings and video presentations. There are other options to bring viewers to the Dale website, links to request samples, contact Customer Service or find local Sales Representatives. “Dale is proud to be among the leaders in the medical device manufacturing industry to deploy this technology. The Virtual Dale Medical Center will enable users to view and handle our products in simulated care settings,” states John Brezack, President of Dale. “The Virtual Dale Medical Center will empower our customers to see how our products can help care for patients and contribute to improved clinical outcomes. They can also view 3-D models of the products and request additional training and information.” The Virtual Dale Medical Center will continue to expand capabilities in the future, including a training center, “C-Suite” and other features.

Dräger Celebrates Legacy of Robert Kacmarek Through Ventilator Donation

Jul 14 2021

To help advance education in the respiratory therapy (RT) profession and honor the life’s work of Robert Kacmarek, PhD, RRT, FCCM, FCCP, FAARC, Dräger is donating a Babylog VN500 ventilator to each RT school throughout the Commonwealth of Massachusetts. This marks the seventh year of Dräger’s RT school donation program, which began in 2014. Dr Robert Kacmarek, professor of Anesthesiology at Harvard Medical School and the director of Respiratory Care at Massachusetts General Hospital, dedicated his career to the growth of the respiratory profession, serving as a member of the American Association for Respiratory Care (AARC) for more than 50 years, writing 19 textbooks, authoring or co-authoring over 300 articles, and presenting more than 700 lectures at respiratory care and medical conferences nationally and worldwide. He passed away on April 1, 2021. Jason Moury, MPH, RRT, president of the Massachusetts Society for Respiratory Care (MSRC), comments on Dr Kacmarek’s work and Dräger’s donation in his honor: “Bob was a humble giant who advocated for the profession and was world-renowned for his teaching. Words cannot express the loss that this profession will feel with his passing. We cannot thank Dräger enough for its donation. We appreciate all that the company has done in support of the RT profession and schools, including this latest contribution to Massachusetts RT programs.”“Robert Kacmarek was a driving force in furthering the RT profession, championing the advancement of higher education in the field, conducting decades of research on respiratory care interventions and training hundreds of students,” said Dräger Senior Vice President of Sales, Hospital Solutions, Steve Menet. “Through our donation of Babylog VN500 ventilators, we honor his legacy and support education of the next generation of respiratory care professionals by enabling them to train on advanced ventilation technology.”

Company Launches Telehealth Solution

JUL 7 2021

CAIRE Inc., pioneers of the portable oxygen concentrator and the only global manufacturer covering the entire continuum of care for the oxygen patient, announced the US launch of its next-generation telehealth solution – myCAIRE – at its corporate headquarters and Respiratory Center of Excellence. Designed to increase the efficiency of administering delivery and improve patient care, the application connects to CAIRE’s leading concentrators via the patient’s smart device and simplifies remote data collection through a secure, cloud-based technology in real-time — easily accessible via the medical equipment provider’s desktop. “It was important to us to have a telehealth solution that connected to CAIRE’s premier oxygen concentrators in the portable, transportable and stationary categories – the full spectrum of oxygen care for patients. Because of this, CAIRE is the only oxygen manufacturer that offers its provider partners a holistic approach to serving the complex healthcare needs of oxygen users during activity or when they are at home,” said Earl Lawson, President and CEO. The myCAIRE application is available through Android, iOS and Surface platforms, and the portal provides customizable views, filtering and search options to view oxygen usage, flow rates, device notifications, equipment location, and requests sent directly from patients to the provider through the app. The timing of the launch supports the needs of providers who administer care to oxygen patients with respiratory conditions, like Chronic Obstructive Pulmonary Disease (COPD), but also the growth in the population of users who have been prescribed oxygen as a therapeutic component to their recovery from the novel coronavirus, COVID-19. The development of telehealth solutions received a giant push during the pandemic according to global consulting firm McKinsey &amp; Company who estimates the market size up to $250 billion. They predict the shift to these platforms will continue to evolve with step-change improvements that impact a variety of providers ultimately resulting in better patient care and outcomes. “We see the use of telehealth as it applies to oxygen therapy equipment to only expand as adoption increases and access opens up,” said Barry Hassett, Vice President of Global Marketing. “This remote visibility to patient data allows the provider to engage with those patients who require more frequent touchpoints in their case management through personal contact and educational resources – the end result is improved care for patients.” In developing this next-generation telehealth solution, the CAIRE team prioritized improvements in functionality and usability while listening to the voice of customers – medical equipment providers who needed something that would help them remotely review data and troubleshoot devices efficiently during a time of increased oxygen demand in the treatment of COVID-19. “Streamlining oxygen patient management can assist in easing up on an already stretched bandwidth for our providers and their teams,” Hassett added. myCAIRE can connect wirelessly to the FreeStyle Comfort portable oxygen concentrator, the Eclipse 5 transportable oxygen concentrator, and the Companion 5 stationary oxygen concentrator. Most newly-prescribed oxygen users utilize a portable or transportable oxygen device to maintain their targeted saturation rate during their daily activities, and an at-home oxygen source – a stationary oxygen concentrator for when they are inside the home – particularly for use while they are at rest. myCAIRE setup is quick, and users will find the free application easy to use with features allowing them to view settings and notifications, share access with a caregiver, request service from their provider, and access the device user manual.

Company Signs Agreement with University

JUL 6 2021

Neotech Products has entered into a mutually beneficial agreement with Wichita State University. This exciting collaboration will provide Neotech with the resources of an institution well known for advanced research, including clinical work through their partners. Wichita State, a national leader in aerospace research, will benefit from the experience of a well-established and innovative medical device company as it expands research in the area of medical products. They will work closely with Neotech’s new product development team to explore product ideas that will impact the end user. “Wichita State is committed to using our aviation expertise for expanding research in other industries,” said Rick Muma, President of Wichita State University. “As a clinician in internal medicine and infectious diseases and a public health practitioner, I understand the need to continually innovate through collaboration in the healthcare sector. Partnerships with companies like Neotech Products do just that.” With this partnership, Neotech will have access to advanced facilities and technologies, including: Labs for materials and adhesive testing and research; Electron microscopes; CT scanning (for materials); Pull and compression testing; A wide array of 3D printing and scanning; VR visual design space. The partnerships’ first collaboration is a locking mechanism for the NeoBar ET Tube Holder. The idea originated with Dr Mohammed Ansari, a neonatologist with ties to the Wichita area. Wichita State teamed up with Dr Ansari and brought the idea to Neotech to drive the project forward. We’re extremely excited to see where it leads. Overall, the purpose of the partnership between Neotech and Wichita State is to utilize the combined expertise of both institutions to bring medical products to market that will truly make a difference.

Low-Dose Nitrous Oxide Shows Benefit for Resistant Depression

JUN 30 2021

A 1-hour treatment with a low concentration of nitrous oxide, commonly known as "laughing gas," appears to relieve symptoms of treatment-resistant major depression (TRMD), with effects lasting as long as several weeks, new research suggests. In a trial with a crossover design, investigators randomly assigned 28 patients with severe TRMD to receive a single 1-hour inhalation of placebo or nitrous oxide once a month over a 3-month period. Participants received an inhalation of placebo; a 25% concentration of nitrous oxide; and a 50% concentration of nitrous oxide. Sessions were conducted 4 weeks apart. Both doses of nitrous oxide were associated with substantial improvement in depressive symptoms for roughly 85% of participants. However, the 25% concentration had a lower risk for adverse effects, which included sedation, nausea, and mild dissociation, compared to the 50% concentration. "Twenty-five percent nitrous has similar efficacy, compared to 50% nitrous oxide, and reduced side effects fourfold," lead author Peter Nagele, MD, chair and professor of anesthesia and critical care, University of Chicago, Chicago, Illinois, said. "We also observed that many patients had a 2-week improvement of depressive symptoms after a nitrous oxide treatment," said Nagele, who is also a professor of psychiatry and behavioral neuroscience.

Frequent Snoring Tied to Increased Asthma Symptoms, Healthcare Use in Kids

JUN 30 2021

Habitual snoring increases odds for maximum asthma symptom days and health care utilization in children with persistent asthma, a study of inner-city kids suggests. Researchers examined data on 339 children (mean age 7.9 years) with persistent asthma whose parents or caregivers completed quarterly surveys for 12 months on asthma symptoms, snoring, health care use, and other outcomes such as missed school for children and disrupted plans or sleep for caregivers. Habitual snoring, defined as at least six nights a week, was reported for 24.8% of the children at the initial assessment. Habitual snorers had significantly more “maximum symptom days” than non-snorers (3.8 vs 2.7 days, odds ratio 1.58), which researchers defined the number of days in the previous two-week period that the children had wheezing, chest tightness, or cough or experienced disrupted sleep or play due to these symptoms. These results aren’t surprising because many risk factors that can increase snoring – pollutants, poor air quality, and tobacco smoke exposure – disproportionately impact inner-city children and can also exacerbate asthma symptoms, said senior study author Dr Wanda Phipatanakul, a researcher at Harvard Medical School and Boston Children’s Hospital. “Awareness of early detection of these factors can help inform early intervention to reduce the morbidity and long-term complications from asthma,” Dr Phipatanakul said by email. A majority of children in the study were from low-income households (72.2%), defined as less than $45,000 a year, and a majority of kids were Black (31.5%) or Hispanic (36.3%). Overall, about half the children in the study had overweight (14%) or obesity (35%), and these conditions were even more prevalent among habitual snorers (17% and 45%, respectively). Habitual snorers were more likely to be obese than non-snorers. The study also found that habitual snoring, compared to non-snoring, was associated with health care utilization (incidence rate ratio 1.72) and worse asthma control (OR 1.49). One limitation of the study is that researchers lacked objective measurements of sleep disordered breathing, the authors note in the Journal of Allergy and Clinical Immunology: In Practice. Recall bias in caregiver reports of asthma symptoms or snoring frequency also may have influenced the results.

Dose-Dependent Effect of 'Internet Addiction' and Sleep Problems

JUN 30 2021

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth. Results from a study of more than 4000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games vs social media networking were the most affected. Sleep issues could be "easily detectable manifestations of pathological internet addiction," investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Krasnoyarsk, Russia, said. These sleep problems require attention and correction, Tereshchenko added. The findings were presented at the virtual Congress of the European Academy of Neurology 2021. IA is a relatively new psychological phenomenon and is most prevalent in "socially vulnerable groups," such as adolescents, Tereshchenko said. He cited numerous studies that have "convincingly demonstrated" IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder. There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters. However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the "general IA pattern" and not the type of IA, Tereshchenko noted. Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

Poor Sleep History Linked With More Severe COVID-19

JUN 30 2021

Poor sleep habits may be linked with higher risk for severe illness in patients with COVID-19, according to Harvard University researchers. They analyzed survey responses from more than 46,000 participants in the long-term UK Biobank study, including 8,422 who tested positive for COVID-19. Participants had answered questions from 2006 to 2010 about sleep duration, daytime sleepiness, insomnia and body clocks. For the new study, based on their responses, the researchers assigned scores ranging from 0 to 6, with higher scores indicating multiple poor sleep “traits.” In participants with COVID-19, poor scores were associated with higher odds of death. This was true even after researchers accounted for issues known to be risk factors for poor COVID-19 outcomes such as sleep apnea, obesity and smoking, they reported on Friday in the journal Clinical Infectious Diseases. Even people with two occasional or one frequent poor sleep trait appeared to experience higher risks for hospitalization and death, although the difference was not statistically significant and more study is needed to confirm the finding, the researchers said. Poor sleep affects the immune system and blood clotting, both of which are key to the body’s fight against COVID-19, and “tracking sleep behavior may have importance in identifying those at increased risk for COVID-19 mortality and hospitalization,” the authors said.

Diagnostic Product Range Updated to Spirometry Standards

JUN 29 2021

NDD Medical Technologies (NDD), a leading provider of diagnostic technology enabling healthcare professionals the early detection of COPD and other chronic lung diseases, has updated the entire EasyOne product range, including the EasyOne Air, Easy on-PC, EasyOne Pro, and EasyOne Pro LAB, to be compliant with the ATS/ERS Standardization of Spirometry 2019. Spirometry is widely used in the assessment of lung function to provide objective information used in the diagnosis of lung disease and monitoring lung health. The updated guidelines aim to improve the quality of the spirometric measurements and improve the patient experience. Committed to usability since the very first EasyOne spirometer, NDD continues this tradition during the implementation of the spirometry 2019 update. The user interface across the product line has seen a major update to help the user navigate through the changes. This is particularly noticeable in the quality assessment of the measured FEV1 and FVC parameters, and the overall quality grading of a test session. As obtaining a high-quality result is essential to the accurate interpretation of the spirometry test outcome, each quality-related criterion proposed by the ATS/ERS standard is analyzed. The user is presented with clear messages on which quality criteria have not been fulfilled, and most importantly, how to coach the patient in order to meet the criteria. The implementation of the ATS/ERS Standardization of Spirometry 2019 update across the entire EasyOne product line is indeed a milestone moment in NDD’s mission of offering reliable, innovative, and easy-to-use products for physicians and patients to combat respiratory disease. However, the journey does not end here, as NDD continues to improve and expand the capabilities of its products and services. The software update with the ATS/ERS spirometry standard 2019 content can be downloaded free-of-charge for EasyOne Air, Easy on-PC, EasyOne Pro and EasyOne Pro LAB at

Committed to Education, MGC Diagnostics Launches Book Giveaway

JUN 23 2021

MGC Diagnostics is the leader in cardiopulmonary diagnostic systems and providing educational opportunities to the respiratory community. Through the years, MGC Diagnostics has been deeply committed to supporting and providing speakers for diagnostic seminars and webinars in addition to state, national & international conferences, as well as other forums throughout the world. They truly believe that knowledge is power, and that the more information you have, the better you can serve your patients and staff. As a way to show their appreciation to those who perform diagnostics testing, MGC Diagnostics is giving away 20 copies of “Ruppel’s Manual of Pulmonary Function Testing”. But the best part is that each book has been individually autographed by both Gregg and Carl – a sure collector’s item. Deadline to enter is July 31st. Winner will be notified by email. Sign up here:

OxyGo Acquires Maker of Portable Emergency Oxygen Devices

MAY 13 2021

OxyGo LLC, a leader in lightweight portable oxygen concentrators, has acquired LIFE Corporation, a manufacturer of medical devices that specializes in portable Emergency Oxygen and CPR administration equipment. Founded in 1985, LIFE Corporation specializes in AED companions to provide supplemental oxygen to a breathing victim before the onset of fibrillation, oxygen enriched CPR to a non-breathing victim, or continued supplemental oxygen after successful defibrillation. LIFE also provides a complete line of medical oxygen regulators and cylinders for LIFE products and separately for EMTs, hospitals, and the home care market. “Acquiring LIFE Corporation is an exciting and logical next step in offering proactive gas solutions to the medical and industrial markets,” said V.E. Marquard-Schultz, Esq., “and continues our mission to help our customers and communities grow.” The acquisition of LIFE Corporation fits into OxyGo’s strategy to offer high quality and market leading service to compressed gas users and the home healthcare market. By purchasing LIFE Corporation, OxyGo can expand their oxygen expertise even further, providing the best product and service. OxyGo is noted for providing high quality home healthcare oxygen products and has been rated as the industry’s best POC—ahead of all competitors the last four years in a row and established itself as a leader of portable oxygen concentrators in North America.

Study Investigates the Ability of Masimo PVi to Predict Preload Responsiveness in Patients On Nasal High-Flow Therapy

MAY 3 2021

Masimo announced the findings of a study published in the Journal of Applied Physiology in which Dr Marina García-de-Acilu and colleagues at the Vall d’Hebron University Hospital in Barcelona evaluated the utility of Masimo PVi as a noninvasive method of predicting preload responsiveness in patients treated with nasal high-flow (NHF) therapy. They found that PVi may identify preload responders and noted that PVi may therefore be used in the “day-to-day clinical decision-making process in critically ill patients treated with NHF, helping to provide adequate resuscitation volume.” More than 100 independent studies have demonstrated the utility of PVi as an indicator of fluid responsiveness. This is the first time PVi has been evaluated in patients treated with NHF therapy. Noting the potential convenience of a noninvasive method of predicting fluid responsiveness in NHF patients, the researchers sought to evaluate whether PVi, which is noninvasive and easy to use, could play such a role. To do so, they compared PVi to reference measurements—stroke volume (SV) and cardiac output (CO)—in 20 adult ICU patients with acute respiratory failure (ARF) supported by NHF (flow ≥ 30 L/min). SV and CO were measured using transthoracic echocardiography (TTE) using a portable echocardiogram. PVi was measured using a Masimo Radical-7 Pulse CO-Oximeter with a pulse oximetry sensor attached to the finger. Within the first 24 hours of NHF support, the patients’ SV/CO and PVi were assessed. Passive leg raising (PLR) was performed and SV/CO and PVi were then reassessed. Preload responsiveness was defined as a ≥ 10% increase in SV after PLR. A fluid challenge was then conducted by administering a 250-mL saline solution to patients who were found to be preload responders (12 of the 20 patients). SV/CO and PVi were measured again after the fluid challenge in these patients. The researchers found that preload responders showed higher baseline PVi values and ΔPVi after PLR. PVi and ΔPVi after PLR showed “excellent diagnostic accuracy for predicting preload responsiveness.” At a baseline cut-off value of 16%, PVi had sensitivity of 91.7% and specificity of 87.8% for discriminating between preload responders and non-responders; a change of 2% or more in PVi allowed for discrimination between the two groups with 100% sensitivity and specificity. Additionally, the researchers found that ΔPVi after PLR and after fluid challenge were strongly correlated (r = 0.84, p < 0.001). The researchers concluded, “This physiological study suggests that PVi might predict preload responsiveness in hypoxemic ARF patients treated with NHF. Further research should focus on validating these results and analyze whether PVi-guided fluid administration can improve outcomes in NHF patients.” The researchers also noted that PVi may not be sufficient to identify preload responders in all patients using NHF, hypothesizing that the intrathoracic pressures delivered by NHF are lower than those generated during invasive mechanical ventilation and that therefore a certain degree of hypoperfusion might potentially be required to effect changes in baseline PVi. The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi. In the US, PVi is cleared as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients.

Company Unveils New Website

APR 27 2021

Vitalograph (USA) Inc. is inviting visitors to explore their new website – The new website allows customers to see the full range of Vitalograph products and services, through a more user-friendly experience with improved navigation and functionality. Created with the customer in mind, the site includes many new features and information on respiratory diagnostic devices, medical equipment, clinical trial services and medical research papers for the respiratory community. New features include: Website split into Healthcare and Clinical Trials to suit the customer journey. Rapid response functionality allowing compatibility with various browsers and mobile devices. Reference Paper Resource area. Clinical Practise Guidelines area. Reimbursement codes information. Product filters to easily narrow down the product portfolio. Online shopping with new cart functionality to streamline the purchasing process. Full information on Vitalograph’s Clinical Trial product solutions and services. Look ahead navigation which reduces the number of clicks to navigate the site. 5 Year-Product Registration and Spirotutor Online Training. In addition, the new product filters allow Vitalograph to place their complete portfolio on the site while still allowing the user to easily navigate through the line. The new Resources section allows visitors to stay informed with the latest industry news, guidelines, and references. The user is always just one click away from useful and pertinent respiratory research, clinical practice guidelines and other spirometry information. Vitalograph is a world-leading provider of the highest quality respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning over half a century, Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.

Company Launches New Software into the US

APR 27 2021

Vitalograph is excited to launch the next generation Spirotrac 6 software into US Healthcare and Occupational Health. Spirotrac 6 PC software provides a powerful respiratory diagnostic platform. This redesigned software is compliant with 2019 ATS/ERS spirometry guidelines, meeting international guidelines on accuracy and reporting. The software includes a 12-lead electrocardiogram (ECG) option with detailed results based on the University of Glasgow interpretation algorithm. A brand-new user interface provides advanced quality control feedback for rapid and easy testing. Filing and storing results could not be simpler with fast connection to your electronic medical record (EMR) system, streamlining your clinical workflow. Five Key Benefits: supports full-feature spirometry testing and bronchodilator responsiveness testing with over 50 available parameters; rovides instant quality feedback using the latest 2019 ATS/ERS spirometry grading, test/session acceptability, usability, and repeatability criteria; uses latest global lung function initiative (GLI) predicted equations with lower limit of normal (LLN), Pred and Z-scores for accurate assessment of abnormality; saves time and ensures consistency with Standardised Operator Comments to quickly add comments to the subject record; ombines spirometry and ECG into one comprehensive patient record. The integrated Glasgow Algorithm provides a computer-generated analysis of potential cardiac abnormalities, a full range of parameters, interpretation, and rhythm analysis.

Company Launches New Device

APR 27 2021

Vitalograph are excited to launch the next generation Pneumotrac spirometer into the US market. The next-generation Vitalograph Pneumotrac Spirometer, combined with Spirotrac PC software, is a powerful tool for respiratory diagnosis of both adults and pediatrics. Capture reliable test results immediately with Pneumotrac’s precise and durable measuring technology which is extremely accurate and stable over time. Connects instantly to your PC by USB, delivering results through the new, improved Spirotrac 6 software. Compliance with the 2019 ATS/ERS spirometry update ensures your service meets international guidelines on accuracy and reporting. The Vitalograph Pneumotrac Spirometer easily connects to your Electronic Medical Records (EMR) system to streamline your clinical workflow. Features include: Highly accurate, robust, and stable Fleisch flow measuring technology with no moving parts; supports full-feature spirometry testing and bronchodilator responsiveness testing with over 50 available parameters; instant quality feedback using the latest 2019 ATS/ERS grading, test/session acceptability, usability, and repeatability criteria; low running costs and environmentally friendly: no need for costly disposable sensors, turbines, adaptors, or flow tubes. Plus free online training and a five-year warranty.

Masimo Announces FDA Clearance of Radius PCG

APR 12 2021

Masimo announced that Radius PCG, a portable real-time capnograph with wireless Bluetooth connectivity, has received FDA 510(k) clearance. Radius PCG connects with the Root Patient Monitoring and Connectivity Platform to provide seamless, tetherless mainstream capnography for patients of all ages. Radius PCG joins the growing family of tetherless Masimo technologies that includes Radius PPG, which offers Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, and Radius T, which provides continuous temperature measurements. Radius PCG requires no routine calibration, with accurate end-tidal carbon dioxide (EtCO2) and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds—all in a small, portable package that can fit in the palm of a hand. “Radius PCG has been a game changer for our clinical team,” commented Joseph DiMartino, MSN RN, NE-BC, CCRN-K, Associate Vice President of Nursing at Temple University Hospital in Philadelphia. “It provides us with a portable and rapid measure of capnography for confirming airway placement in accordance with AHA guidelines.” Wirelessly connected to Root, Radius PCG presents a compelling mainstream capnography solution, offering: Cable-free Capnography: High-quality capnography without a tethered connection to Root reduces the possibility of an interruption in capnography monitoring by minimizing tugging on the breathing circuit. In busy operating rooms, where space is already at a premium, and where capnography cables can easily be pulled and dropped on the floor—potentially damaging the fragile and expensive capnography sensor head—the reduction in clutter may be especially welcome. Automated Documentation: Root, in conjunction with the Masimo Hospital Automation Platform, automates electronic charting of patient data, including the data collected by Radius PCG, in hospital electronic medical record (EMR) systems, to simplify and speed workflows, as well as reduce the likelihood of transcription errors. Maximized Data Visibility and Manipulation: Root’s large, multi-touch, high-resolution screen provides an easily interpretable secondary display of large, crisp EtCO2 waveforms, improving visibility and assisting clinicians in identifying wave patterns suggestive of airway obstruction or tube dislodgement. Clearly displayed trend data for up to 96 hours helps clinicians review patient progress over time, helping guide ventilation efforts. And the intuitive touch-screen interface allows clinicians to quickly adjust the trend display range and configure alarm settings to meet the needs of each patient. Hassle-free Connectivity: Radius PCG quickly and effortlessly pairs with Root via Bluetooth, supporting seamless integration into clinical workflows while providing the benefits of reliable capnography. Tom Friedland, MD, Emergency Medicine Physician, described Radius PCG as “the easiest and most affordable solution to switch your hospital from the unreliable color change CO2 detector to waveform capnography. #NoTraceWrongPlace.” “Radius PCG is indispensable for emergencies, as well as for monitoring the COVID patients in our house,” added Kai Schurig, Head of the Biomedical Department at Marien Hospital in Hamburg, Germany. “These handheld devices are very reliable and fail very rarely. The users are very satisfied and treat the device accordingly.” Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with Radius PCG and many other measurements, such as Masimo SET, advanced rainbow Pulse CO-Oximetry measurements, O3 regional oximetry, and SedLine brain function monitoring, for expanded visibility of patient status. Using Root in combination with the Hospital Automation Platform, monitoring data from all connected devices can be automatically charted in EMRs. Joe Kiani, Founder and CEO of Masimo, said, “With its wireless connectivity, Radius PCG is a powerful and useful tool for assessing end-tidal CO2 in a multitude of clinical scenarios. Masimo continues to make clinically relevant, accurate patient data available, helping clinicians gain the insights they need to make the best decisions and improve patient outcomes.”

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

APR 12 2021

Genentech, a member of the Roche Group announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps. “Today's approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic.” Before starting self-injection with Xolair prefilled syringe, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity (allergic reactions). After Xolair therapy has been initiated and safely established in a healthcare setting, a healthcare provider may determine whether self-injection with Xolair prefilled syringe by the patient or a caregiver is appropriate. The healthcare provider must train the patient or caregiver on the correct subcutaneous injection technique, how to recognize the signs and symptoms of anaphylaxis and how to treat anaphylaxis appropriately, before the first self-injection outside a healthcare setting. “Expanding treatment options for personalized care and self-management is always welcome news for the patient community,” said Kenneth Mendez, CEO and President, Asthma and Allergy Foundation of America. “The possibility of administering FDA-approved treatment outside of the healthcare provider’s office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers.” Approximately 460,000 patients have been treated in the US with Xolair since its initial approval in 2003. The use of Xolair across allergic asthma, CIU and nasal polyps is based on its well-established efficacy and safety profile and supported by a robust clinical development program, including 10 Phase III studies. In the US, Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

Confront Today’s Challenges with Cardiorespiratory Diagnostic Software

MAR 29 2021

The respiratory industry is ever growing and changing. With new studies and trials being conducted, new treatment methods and disease challenges are often discovered. This means that reliable and efficient methods for diagnosing pulmonary disorders are needed. As COVID-19 continues, mild to severe lung damage has been found in some patients post-Covid, which often requires Pulmonary Function Tests to determine the extent of damage, monitor the progress and to create a treatment plan. Add to that the number of patients with Chronic Obstructive Pulmonary Disease (COPD), a progressive and chronic disease. According to the American Lung Association, COPD is the third leading cause of death in the world. It is estimated that over 300 million people worldwide have COPD. As we can see, the need for Pulmonary Function Testing is only going to increase. In the respiratory industry, manufacturers introduce new diagnostic software about once every 15 years. With these thoughts in mind, MGC Diagnostics has a solution to help solve today’s challenges. MGC Diagnostics’ new Ascent cardiorespiratory diagnostic software for pulmonary function testing has been designed from the ground up to be the most advanced testing software platform available. Their easy-to-use, powerful, and versatile software allows you to obtain the very best data possible so that a diagnosis can be made confidently. It’s simple. Improving the diagnosis of patients starts with diagnostic tests done correctly and according to ATS/ERS standards. The ease in which data is collected, accessed, and reviewed helps to ensure an effective patient outcome. The dynamic on-screen instructions within the software walk the technologist through the entire testing process. Ascent software’s unique Insight quality control gauge shows if an effort has passed ATS/ERS quality standards in Real-Time while the patient is performing the effort. With enhanced graphics, know at-a-glance if a test effort meets your labs’ standards and are acceptable for diagnostic purposes. After the test is complete, data can be reviewed quickly and efficiently. Completely customizable comments can be generated to summarize the quality of each effort more quickly and accurately than ever before. And the computerized interpretation can be tailored to the individual physician.

Study Investigates the Impact of Automating Respiration Rate Measurement Using this Device

MAR 29 2021

Masimo announced the results of a prospective, observational study published in Acta Paediatrica in which researchers from the Hospital for Sick Children in Toronto evaluated the accuracy of plethysmographic respiration rate measurement (RRp) using Masimo Rad-G, a rugged, handheld device, on malnourished, hospitalized children in Nigeria. Noting that in resource-limited environments, respiration rate (RR) measurement is often used to directly inform medical decisions for children with respiratory problems, but that manual RR counting “remains a challenge,” Dr Nancy Dale and colleagues investigated whether a technological solution might provide a useful alternative to manual counting. To make the evaluation, the researchers compared simultaneous device measurements and nurse-measured manual RR counts on malnourished children. The device chosen was the Masimo Rad-G, which uses a pulse oximetry sensor to measure both oxygen saturation and RRp, and which has been shown to provide good agreement between RRp and pediatrician-measured RR. They enrolled 514 children, aged 6 to 59 months, who were hospitalized between July 2019 and May 2020, in Borno State, Nigeria. Study nurses were trained to operate Rad-G and also perform manual RR counts as part of twice-daily patient assessment. RR was manually counted for 60 seconds while Rad-G simultaneously measured RRp via a sensor attached to the patient’s toe, and both measurements were recorded. Analyzing the 6,889 paired RR measurements, the researchers found that the mean Rad-G RRp reading was 1.3 bpm (95% confidence interval 1.2 – 1.4 bpm) higher than the mean manual RR value. The mean absolute difference between the two methods was 4.4 bpm (95% CI 4.3 – 4.5 bpm). When RR was classified as either “normal” or “fast” breathing (using WHO pneumonia thresholds), the two methods resulted in the same classification 84% of the time. When RR was classified according to BedsidePEWS RR sub-scoring (a 4-point scale), 80% of the scores were the same, and 99.3% were within 1 point. The researchers concluded that their findings “highlight the potential clinical impact of changing practice from manual to automated RR count. Clinical implementation of the device should be carefully monitored to measure impact on patient outcomes.” Study co-author Dr Stanley Zlotkin commented, “Technical solutions to improve clinical care are laudable. We look forward to continuing this research.” RRp is one of multiple RR monitoring modalities offered by Masimo, which also include acoustic respiration rate (RRa) and NomoLine capnography (RRc), helping clinicians ensure they have the most suitable tool for each patient scenario. First developed in partnership with The Bill & Melinda Gates Foundation, Rad-G is a rugged, handheld device that provides clinically proven Masimo SET pulse oximetry, respiration rate (RRp), and other important parameters. With its long-lasting rechargeable battery, robust rubber casing, and light weight, Rad-G makes it easier for clinicians to quickly assess patients and make informed care decisions anywhere pulse oximetry or vital signs checking is needed in a compact, portable form factor. Coupled with the universal Mini-Clip pulse oximeter sensor to provide the ultimate in handheld versatility, Rad-G can be used in a variety of settings, including limited-resource environments, both indoors and in the field.

FDA Clears Use of Oscillating Positive Expiratory Pressure Products

MAR 19 2021

D•R Burton Healthcare Products LLC is a leading manufacturer of Oscillating Positive Expiratory Pressure (OPEP) products that treat the symptoms of COVID-19. D•R Burton OPEP products provide supporting treatment of some COVID-19 symptoms, particularly symptoms of respiratory airway infections that can precede pneumonia and further progress to more serious complications. The FDA has cleared the use of Oscillating Positive Expiratory Pressure (OPEP) products which are known to decrease the burden of respiratory pathogens by promoting airway secretion clearance. OPEPs are widely accepted by the medical community for helping to reduce the likelihood that respiratory infections progress to pneumonia and even more serious complications including death. Despite the familiarity in the medical community with these products, OPEPs are largely unknown to the U.S. general public except for patients living with chronic lung diseases such as Cystic Fibrosis, COPD, and Bronchiectasis to name a few. D•R Burton manufactures small hand-held OPEPs that can be easily self-administered in hospitals, nursing homes, and the home setting by most patients. These devices can also be filtered with a common bacteria/viral filter to alleviate concern of droplet transmission. While researchers race for a cure, our country and the world face a public health challenge of treating infected people. OPEP therapy is not a direct treatment for the COVID-19 virus, but it is our hope that increased awareness of OPEP therapy could help in the current health challenge by offering proven and available therapy for symptoms of respiratory tract infections associated with the COVID-19 virus.

Survey Shows Stress Over the Past Year Is Negatively Impacting Quality of Sleep

MAR 15 2021

ResMed, a world-leading digital health company, announced today the results of a nationwide survey of 1,000 adults, which revealed that for half of Americans, stress over the past year is negatively impacting the quality of their sleep—and many are ignoring sleep challenges that could point to a larger underlying health concern. ResMed published the survey in conjunction with National Sleep Awareness Week (March 14-20) and World Sleep Day (March 19), and as part of Sleep for a Better Tomorrow, an education and outreach initiative to build awareness of the critical role good sleep plays in physical and mental health—and how to get our best sleep. “COVID-19 has impacted all aspects of our lives, including our sleep health, leading many people to struggle to get the recommended seven to nine hours of sleep at night,” said Carlos M. Nunez, M.D., chief medical officer for ResMed. Beyond the pervasive effects of stress, the survey found the impacts on sleep vary across gender and working arrangements: 35% of women reported worse sleep quality in the past year compared to just 26% of men. Women selected stress and anxiety as the most significant impacts on their sleep; more individuals working from home reported improved sleep quality since the pandemic began vs. those who haven’t worked from home (39% vs. 21%). Across all respondents, more than one-third say they are having a harder time falling asleep, and nearly one-third say they are sleeping less over the last year, and one-quarter started taking naps more often. While COVID-related stresses are often noticeable, one of the biggest stealers of our sleep might be something we can’t easily detect: sleep apnea. The survey revealed that more than one in two Americans say they snore, or a bed partner has told them they snore, yet 78% of those who snore aren’t concerned it could be related to an underlying health condition, despite snoring being a top symptom of sleep apnea. Additionally, nearly half of survey respondents said their doctor had not asked them about their sleep quality, reinforcing the importance of consumers being aware of the potential health impacts of poor sleep and acting on key sleep apnea symptoms such as snoring. “While data show that stress and worry are key factors impacting many people’s sleep, now is an opportunity for everyone to take measure of all of the factors that could be impacting the quality of their sleep, which could include sleep disorders that can have negative long-term impacts to overall health,” said Nunez. Everyone experiences a lousy night of sleep once in a while; however, those who experience ongoing sleep issues could be dealing with a more significant underlying health condition. Most survey respondents who snore overwhelmingly discount the potential health impacts, yet snoring is the most prevalent symptom of sleep apnea – one of the most common sleep disorders. Over 54 million adults in the U.S. have sleep apnea, but more than 80% don’t know they have it. Undiagnosed and untreated sleep apnea may increase your risk for developing other chronic and life-threatening conditions, including high blood pressure, heart disease, and Type 2 diabetes. “Sleep apnea can impact all types of people from all walks of life, and while some people are more prone to have sleep apnea, it does not discriminate,” said Nunez. “If you snore, have been told you stop breathing in your sleep, or feel tired each day despite getting enough hours of sleep, ask your doctor if sleep apnea – which is 100% treatable at home – could be the cause.” To learn more about ResMed’s sleep surveyor to take a free quiz about your risk for sleep apnea, visit

New Study Evaluates the Ability of Masimo EMMA Capnography to Assess the Respiratory Status of Children with Tracheostomy

MAR 15 2021

Masimo announced the findings of an observational, retrospective study published in Pediatrics International. In the study, researchers at the Osaka Women’s and Children’s Hospital in Japan found the Masimo EMMA Portable Capnograph “useful for assessment of the respiratory condition in children with tracheostomy.” EMMA provides seamless mainstream capnography for patients of all ages in a compact, easily portable device. The device requires no routine calibration and minimal warm-up time, with accurate end-tidal carbon dioxide (EtCO2) and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds. Noting the potential value of a compact and portable way to monitor changes in respiratory status for patients in scenarios where typical inpatient hospital monitoring equipment is less likely to be available, Dr Masashi Hotta and colleagues sought to evaluate the utility of the EMMA capnograph on children with tracheostomy by comparing EtCO2 values from the EMMA device (which was connected to the distal side of the tracheostomy cannula) to invasively measured partial pressure of venous carbon dioxide (PvCO2). Although partial pressure of arterial carbon dioxide (PaCO2) is considered a gold standard for assessing respiratory condition, the researchers chose PvCO2 because “collection of arterial samples is more invasive than collection of venous samples” and noted that studies have shown a correlation between PaCO2 and PvCO2. They enrolled 9 infants (median age 8 months) and compared 43 paired EtCO2-PvCO2 readings in total. The researchers found a correlation coefficient of 0.87 (95% confidence interval of 0.7 – 0.93; p < 0.001) between EtCO2 and PvCO2 readings. Analysis of the data revealed that EtCO2 readings were, on average, 10.0 mmHg lower than the corresponding paired PvCO2 value (95% limits of agreement of 1.0 – 19.1 mmHg). The researchers speculated that the tendency for EtCO2 to be lower than PvCO2 may be explained by “gas mixing proximal to the tracheostomy cannula due to the presence of anatomic and physiologic dead space. Because almost all patients used a cannula without a cuff, some air leakage may have occurred. In addition, about two-thirds of the patients had [chronic lung disease or bronchopulmonary dysplasia],” which they noted have been shown to cause lower CO2 concentrations during exhalation, relative to the partial pressure of CO2 in the blood. They also found that the median difference in values was significantly greater for readings collected while patients were on mechanical ventilation (28 of the 43 data pairs). With a ventilator, there was a median 11.2 mmHg (6.8 – 14.3) difference; without a ventilator, there was a median 6.6 mmHg (4.1 – 9.0) difference (p = 0.043). The researchers noted that use of a ventilator was significantly related to the difference in paired readings because patients on ventilators had respiratory or circulatory disease. Noting that, “We demonstrated a strong positive relationship between PvCO2 and EtCO2 and revealed the availability and usefulness of this capnometer for children with tracheostomy,” the researchers concluded, “EMMA is useful for assessment of the respiratory condition in children with tracheostomy. EMMA can be used especially in home-care settings and outpatient departments for such children.” They also noted, “The main strength of this study is that we used a portable capnometer to evaluate EtCO2.”

Asthma-COPD Overlap Linked to Occupational Pollutants

MAR 15 2021

The development and worsening of overlapping asthma and chronic obstructive pulmonary disease (COPD) can be affected by pollutants found in rural and urban environments, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year. a“Urban-rural-occupational air pollutants or respiratory sensitizers impact asthma and the asthma-COPD overlap features,” Jill A. Poole, MD, division chief of allergy and immunology at the University of Nebraska Medical Center, Omaha, said in her presentation. The Global Initiative for Asthma (GINA) first outlined a syndrome in 2015 described as “persistent airflow limitation with several features usually associated with asthma and several features usually associated with COPD” and called asthma-COPD overlap syndrome. In 2017, a joint American Thoracic Society/National Heart, Lung, and Blood Institute workshop outlined knowledge gaps about asthma-COPD overlap, noting it “does not represent a single discrete disease entity.” “This is not a single disease and should be thought of as being heterogeneous and used as a descriptive label for patients commonly seen in clinical practice,” Dr Poole said. “Both asthma and COPD definitions are not mutually exclusive because each disease includes several phenotypes with different underlining mechanisms.” An example of how asthma-COPD overlap might present is through a patient with allergic asthma who has a history of smoking who develops airflow obstruction that isn’t fully reversible, or a patient with COPD “with high reversible airflow, obstruction, type 2 inflammation, and perhaps the presence of peripheral blood eosinophils or sputum eosinophils.” A patient’s interaction with urban, rural, and occupational environments may additionally impact their disease, Dr Poole explained. “The environmental factors of an urban versus rural environment may not be necessarily mutually exclusive,” she said. “It’s also important to recognize occupational exposures that can be both seen in an urban or rural environment [can] contribute to asthma-COPD overlap.” In a study of 6,040 men and women with asthma living in Canada, 630 (10.4%) had asthma-COPD overlap, with increased air pollution raising the likelihood of developing asthma-COPD overlap (odds ratio, 2.78; 95% confidence interval, 1.62-4.78). These people experienced later onset asthma, increased emergency department visits before a diagnosis of COPD, and increased mortality. Another study in Canada of women from Ontario in the Breast Cancer Screening Study found 1,705 of 4,051 women with asthma also had COPD. While air pollution did not increase the risk of developing asthma-COPD overlap, there was an association between body mass index, low level of education, living in a rural area, and smoking status. Among farmers in rural areas, “it has been recognized that there is something called the asthma-like syndrome that’s been reported in adult farming communities,” Dr Poole said, which includes “some degree of airflow obstruction and reversibility” that can be worsened by smoking and could be an overlap of asthma and COPD. Farmers can also experience asthma exacerbations while working, and “livestock farmers appear more at risk of developing [chronic bronchitis and/or COPD] than do the crop farmers,” she noted. Occupational environments outside of agriculture exposure can cause incident asthma, with high-molecular-weight antigens such as flour cereal, animal dander, latex, psyllium, crab processing products, and enzymes as well as low-molecular-weight antigens such as isocyanates, woods, antibiotics, glues, epoxies colophony products, and dyes presenting a risk. In food processing, main allergen sources can include raw and processed animal and plant products, additives and preservatives, contaminants from microbes or insects, inhaled dust particles or aerosols, which can be “IgE mediated, mixed IgE-mediated and non-lgE mediated.” While some studies have been conducted on the prevalence of work-related asthma and asthma-COPD overlap, “in general, the prevalence and clinical features have been scarcely investigated,” Dr Poole said. One survey of 23,137 patients found 52.9% of adults with work-related asthma also had COPD, compared with 25.6% of participants whose asthma was not work related. To prevent asthma-COPD overlap, Dr Poole recommended tobacco cessation, reducing indoor biomass fuel use, medical surveillance programs such as preplacement questionnaires, and considering “reducing exposure to the respiratory sensitizers with ideally monitoring the levels to keep the levels below the permissible limits.” Dr Poole noted there is currently no unique treatment for asthma-COPD overlap, but it is “important to fully characterize and phenotype your individual patients, looking for eosinophilia or seeing if they have more neutrophil features and whether or not the allergy features are prevalent and can be treated,” she said. “[A]wareness is really required such that counseling is encouraged for prevention and or interventional strategies as we move forward.” For patients with features of both asthma and COPD where there is a high likelihood of asthma, treat the disease as if it were asthma, Dr Poole said, but clinicians should follow GINA GOLD COPD treatment recommendations, adding on long-acting beta-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) when needed, but avoiding LABAs and/or LAMAs without use of inhaled corticosteroids, and avoiding oral corticosteroids entirely. Clinicians should be reviewing the treatments of patients with asthma and COPD features “every 2-3 months to see how their response is to it, and what additional therapies could be used,” she said. Dr Poole reports receiving grant support from National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health, and the Central States Center for Agricultural Safety and Health at the University of Nebraska Medical Center.

Vivo 45 LS Ventilator Introduced to the US

FEB 12 2021

Breas Medical USA announced the market introduction of the Vivo 45 LS, one of the smallest, full-featured Life Support devices on the market. The Vivo 45 LS is cleared by the US FDA to provide both invasive and non-invasive continuous or intermittent ventilatory support across the continuum of care in the home, post-acute, hospital and portable applications for pediatric through adult patients weighing more than 5 kg (11 lbs). “The ultra-portable Vivo 45 LS life support ventilator is designed to maximize independence and mobility to the patient thanks to its ultra-small footprint, utilizing the comfortable eSync trigger technology used in the Vivo 65 with added ultra-quiet operation,” said Chris Southerland, General Manager, Breas Americas. “The Vivo 45 LS has the added benefit of offering patient monitoring of etCO2, SpO2, FiO2 and PtCO2 and can be connected to EveryWare, Breas’ securely hosted, remote cloud-based application, which can help deliver an insightful approach to the care of respiratory patients in the home.” Engineered in our founding Swedish and USA offices, Breas delivers leading edge innovations that can provide patient comfort and mobility needed to improve their quality of life. To learn more about the exclusive eSync™ technology, ultra-quiet operation, long battery life and integrated ventilation monitoring value for patients and caregivers alike visit Breas Medical was founded in Gothenburg, Sweden in 1991 and has provided innovative respiratory medical device products to the global market for 30 years. Breas has long been known for its Swedish design, reliable technology and ease of use. Breas offers a comprehensive line of respiratory medical devices in Homecare Life Support Ventilation and Non-Invasive Ventilation, Airway Clearance and CPAP treatment.

New Study in Newborns Finds Nellcor Pulse Oximetry Technology Provides Fast Stable Oxygen Saturation Readings

FEB 9 2021

Medtronic announced the results of an independent, prospective observational study comparing the efficacy and reliability of two pulse oximeters — Nellcor Bedside SpO2 Patient Monitoring System and Masimo Radical-7 Pulse CO-Oximeter, both set at the highest sensitivity ("Neonatal" and "Fast" for Nellcor pulse oximetry technology and "Max" for Masimo) — with electrocardiography (ECG) monitoring following the delivery of 60 term newborns by Caesarian section. Pulse oximetry is a simple, noninvasive bedside test that can accurately detect the percentage of blood saturated with oxygen and measure heart rate. According to the study, a stable signal was obtained from all 60 newborns with the Nellcor pulse oximeter but from only 55 newborns with the Masimo pulse oximeter. Of the 55 newborns with stable signals from both monitors, the mean time to stable signal with the Nellcor pulse oximeter was 15 seconds compared with 27 seconds with the Masimo pulse oximeter. The average difference of 12 seconds between the monitors was statistically significant (P <0.001). The results of this prospective observational comparative study were published online in the Journal of Perinatology, the official journal of the Section on Neonatal-Perinatal Medicine of the American Academy of Pediatrics and the Neonatal-Perinatal Association of the United States. The study was conducted at the Rabin Medical Center, Petach Tikvah, Israel, a university-affiliated tertiary care center with approximately 9,000 births annually. The principal investigator of the study is Professor Ruben Bromiker, MD, Department of Neonatology, Schneider Children's Medical Center of Israel, Petach Tikvah, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. The availability of a pulse oximeter for monitoring oxygenation and heart rate of newborns contributes to decision making during resuscitation and stabilization, and can help physicians minimize the risk of either too low or too high blood oxygen levels and associated morbidity and mortality, the authors state in the discussion section. Both the Nellcor and Masimo pulse oximeters provide relatively quick measurements of oxygen saturation and heart rate in most cases well before the so-called "golden first minute" of resuscitation. The results conclude that Nellcor showed a statistically significant difference in the time needed to deliver a stable signal between devices which could potentially impact the provision of care during neonatal resuscitation. With respect to heart rate, the study observed there was a difference of 12 beats per minute (BPM) between the Masimo monitor and the reference standard ECG in 18 of 51 (35%) newborns. In all 18 newborns, the ECG showed a heart rate >100 BPM versus <100 BPM with the Masimo monitor, which may be observed as false bradycardia with the Masimo device. In 16 of the 51 (31%) newborns, the difference in heart rate with the Masimo monitor was 40 BPM compared with the rate recorded by the comparator ECG. In contrast, the heart rate detected by the Nellcor pulse oximetry monitor correlated closely with that of the ECG, with no recording of false bradycardia and no reading having >40 BPM difference compared with the ECG. "A newborn's heart rate is a key component of physician assessment for resuscitation, and helps to identify not only those in need of intervention but also their response to treatment. Those who do not achieve a heart rate of 100 beats per minute by five minutes of life are at an increased risk of death," said Frank Chan, president, Patient Monitoring, which is reported as part of the Minimally Invasive Therapies Group at Medtronic. "This study demonstrates that physicians can rely on Nellcor pulse oximetry technology to post data quickly, offer consistency, perform well with these patients, and meet the requirements of the neonatal resuscitation program guidelines, which are especially important in the delivery room." These findings are important because, per the neonatal resuscitation program (NRP) guidelines, only one minute should be allotted for completing the initial monitoring steps to inform reevaluation and initiation of ventilation.

Device Gets Clearance

FEB 01 2021

3B Medical, Inc. announced receiving FDA 510(k) clearance on its new third generation bi-level device, the Luna G3 Auto-BPAP. The Luna G3 Auto BPAP is a modern and technologically advanced Bi-Level PAP therapy device for the treatment of obstructive sleep apnea. This device is available with integrated heated tubing, cellular connectivity and 3B's advanced algorithm which automatically senses and adjusts pressure settings to ensure airway patency for a comfortable night's sleep. The Luna G3 Auto-BPAP provides a backup rate that reduces the work of breathing with pressure settings up to 25 cmH20. "We are excited by FDA's recent action approving use of the Lumin G3 Auto-BPAP. The Luna G3 is 3B Medical's third generation platform and incorporates a new design, a smaller footprint, and more advanced functionality", said Justin Smith, 3B Medical's Chief Operating Officer. The Luna G3 Auto-BPAP delivers non-invasive ventilator support with all of the bells and whistles that DME's have come to expect from 3B Medical", said Smith. 3B Medical is a leader in the development, marketing and distribution of medical products for the treatment of sleep therapy, oxygen therapy and disinfection

Maternal COVID Antibodies Cross Placenta, Detected in Newborns

JAN 29 2021

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented at the virtual Society for Maternal-Fetal Medicine (SMFM) 2021 Annual Pregnancy Meeting. "I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection," Naima Joseph, MD, MPH, of the Emory University School of Medicine, Atlanta, Georgia, said. "Our data demonstrate maternal capacity to mount an appropriate and robust immune response," and maternal protective immunity lasted at least 28 days after infection, Joseph said. "Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates." The researchers analyzed the amount of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein. The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days. All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies. "It's reassuring that so far, the physiological response is exactly what we expected it to be," Judette Louis, MD, MPH, an associate professor of ob/gyn and the ob/gyn department chair at the University of South Florida, Tampa, Florida, said. "It's what we would expect, but it's always helpful to have more data to support that. Otherwise, you're extrapolating from what you know from other conditions," said Louis, who moderated the oral abstracts session. Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Benralizumab Improves Health-Related Quality of Life in Severe Eosinophilic Asthma

JAN 29 2021

Severe eosinophilic asthma can cause airway hyperresponsiveness, worsening symptoms, and decreased lung function for patients, often leading to recurrent or maintenance corticosteroid use and deeply conditioning patients’ quality of life. A team, led by Carla Maria Irene Quarato, University of Foggia, determined if and how an add-on treatment with benralizumab could improve the quality of life of patients with severe eosinophilic asthma in data at the European Respiratory Society International Congress 2020 (ERS 2020). The study included 10 outpatients with severe eosinophilic asthma, 7 of which were female. Each patient received treatment added-on with benralizumab and was followed-up with in an accredited outpatient clinic for severe asthma at 12 and 24 weeks. The investigators assessed quality of life during each visit using the Asthma Quality of Life Questionnaire (AQLQ), EuroQol-visual analogue scales (EQ-VAS), and EuroQol-5Dimensions-3Levels (EQ-3D-5L). The researchers found both a significant reduction in eosinophilic inflammation, exacerbations, and gaining in pre-bronchodilator FEV1 and symptoms control, with all the enrolled subjects experiencing an improvement in AQLQ [from 3.65±0.56 (baseline) to 4.61±0.67 (12 weeks) (P = 0.003) and to 5.17±0.87 (24 weeks) (P = 0.0002)]. This covered all 4 health domains—symptoms perception, activity limitation, emotional function, and environmental stimuli—investigated (P <0.05). The patients also saw an improvement in EQ-VAS (from 44.5±7.7% (baseline) to 60.5±6.6% (12 weeks) (P = 0.002) and to 86.7±7.2% (24 weeks) (P <0.001), with a statistically significant reduction in severe limitation in all dimensions—mobility, self-care, daily activities, pain/discomfort and anxiety/depression (P <0.001). “Our real life experience confirms the effectiveness of benralizumab as an add-on treatment in restoring patients with severe eosinophilic asthma to a better [quality of life] perception already after 12 weeks of treatment,” the authors wrote. Recent study findings from the ANDHI trial further back the efficacy and safety of benralizumab for patients with severe asthma. The study extended knowledge and understanding of the efficacy and safety of benralizumab for severe eosinophilic asthma patients, including the onset of effect and additional health-related quality of life measures. They included adult patients with severe eosinophilic asthma with at least 2 prior-year exacerbations despite high-dosage inhaled corticosteroid plus additional controllers and screening blood eosinophil counts of at least 150 cells/µL. Patients were randomized 2:1 to either 24 weeks of benralizumab 30 mg every 8 weeks or placebo. Nasal polyposis was present for 34.2% of those in the benralizumab group and 35.8% of placebo patients, with a mean SNOT-22 of 51.5 for benralizumab versus 48.2 for placebo. The team found benralizumab significantly improved asthma exacerbation rate, with a 49% reduction versus placebo (.94 vs 1.86; P <.0001). There was also a clinically meaningful and statistically significant improvement in least-squares mean change in SGRQ total score at week 24 versus placebo (delta-8.11; P <.0001), with similar differences at earlier times throughout the study period. Benralizumab improved lung function, ACQ-6, and SNOT-22 at week 24 versus placebo.

Asthma-COPD Overlap: Patients Have High Disease Burden

JAN 29 2021

Patients with asthma–chronic obstructive pulmonary disease overlap (ACO) experienced a higher burden of disease than patients with either asthma or COPD alone, a recent study has found. Approximately 20% of chronic obstructive airway disease cases are ACO, but data on these patients are limited, as they are often excluded from clinical trials, wrote Sarah A. Hiles, MD, of the University of Newcastle (Australia) and colleagues. “Comparing the burden of eosinophilic ACO, eosinophilic severe asthma, and eosinophilic COPD may also help contextualize findings from phenotype-targeted treatments in different diagnostic groups, such as the limited success of anti-IL [interleukin]–5 monoclonal antibodies as therapy in eosinophilic COPD,” they said. In a cross-sectional, observational study published in Respirology the researchers recruited patients aged 18 years and older with a confirmed diagnosis of COPD only (153) severe asthma only (64), or ACO (106). Patients were assessed for demographic and clinical factors including health-related quality of life, past-year exacerbation, and other indicators of disease burden. In addition, patients were identified as having eosinophilic airway disease based on a blood eosinophil count of at least 0.3x109/L. Overall, eosinophilic airway disease was present in 41% of the patients; 55%, 44%, and 29% for those with ACO, severe asthma, and COPD, respectively. Reports of poor health-related quality of life and past-year exacerbations were similar for eosinophilic patients across all three conditions. However, patients with eosinophilic ACO experienced significantly more past-year exacerbations, notably those requiring oral corticosteroids, compared with patients with asthma alone. In addition, the cumulative number of past-year exacerbations in patient with eosinophilic disease was 164 in those with ACO, compared with severe asthma alone (44) and COPD alone (59). Patients with ACO also had significantly higher disease burden based on the St. George’s Respiratory Questionnaire (SGRQ), which assessed functional limitation. “For 100 patients, the cumulative SGRQ score attributable to eosinophilic airways disease in ACO was 2,872.8, which was higher than in severe asthma (1,942.5) or COPD (1,638.1),” the researchers said. The study was limited by several factors including the cross-sectional design and use of a single measurement to classify eosinophilia, the researchers noted. “The non-eosinophilic group likely included a mix of patients with treated eosinophilia and patients without eosinophilia, regardless of treatment, which is a limitation to consider when interpreting the disease burden estimates in this group,” they added. However, the results add to the understanding of blood eosinophils in airway disease and the study “supports eosinophilia as a phenotype that spans across disease labels of severe asthma and COPD, and their overlap,” they concluded. The study was supported by AstraZeneca; lead author Dr. Hiles received a salary through a grant from AstraZeneca to the University of Newcastle while conducting the study. Other coauthors disclosed relationships with companies including AstraZeneca, GlaxoSmithKline, Menarini, and Novartis.

Asthma-COPD Overlap: Patients Have High Disease Burden

JAN 16 2021

Patients with asthma–chronic obstructive pulmonary disease overlap (ACO) experienced a higher burden of disease than patients with either asthma or COPD alone, a recent study has found. Approximately 20% of chronic obstructive airway disease cases are ACO, but data on these patients are limited, as they are often excluded from clinical trials, wrote Sarah A. Hiles, MD, of the University of Newcastle (Australia) and colleagues. “Comparing the burden of eosinophilic ACO, eosinophilic severe asthma, and eosinophilic COPD may also help contextualize findings from phenotype-targeted treatments in different diagnostic groups, such as the limited success of anti-IL [interleukin]–5 monoclonal antibodies as therapy in eosinophilic COPD,” they said. In a cross-sectional, observational study published in Respirology the researchers recruited patients aged 18 years and older with a confirmed diagnosis of COPD only (153) severe asthma only (64), or ACO (106). Patients were assessed for demographic and clinical factors including health-related quality of life, past-year exacerbation, and other indicators of disease burden. In addition, patients were identified as having eosinophilic airway disease based on a blood eosinophil count of at least 0.3x109/L. Overall, eosinophilic airway disease was present in 41% of the patients; 55%, 44%, and 29% for those with ACO, severe asthma, and COPD, respectively. Reports of poor health-related quality of life and past-year exacerbations were similar for eosinophilic patients across all three conditions. However, patients with eosinophilic ACO experienced significantly more past-year exacerbations, notably those requiring oral corticosteroids, compared with patients with asthma alone. In addition, the cumulative number of past-year exacerbations in patient with eosinophilic disease was 164 in those with ACO, compared with severe asthma alone (44) and COPD alone (59). Patients with ACO also had significantly higher disease burden based on the St. George’s Respiratory Questionnaire (SGRQ), which assessed functional limitation. “For 100 patients, the cumulative SGRQ score attributable to eosinophilic airways disease in ACO was 2,872.8, which was higher than in severe asthma (1,942.5) or COPD (1,638.1),” the researchers said. The study was limited by several factors including the cross-sectional design and use of a single measurement to classify eosinophilia, the researchers noted. “The non-eosinophilic group likely included a mix of patients with treated eosinophilia and patients without eosinophilia, regardless of treatment, which is a limitation to consider when interpreting the disease burden estimates in this group,” they added. However, the results add to the understanding of blood eosinophils in airway disease and the study “supports eosinophilia as a phenotype that spans across disease labels of severe asthma and COPD, and their overlap,” they concluded.

Asthma Inhaler Sensors Improve Pediatric Asthma Control

JAN 16 2021

Sensor-based inhaler monitoring with clinical feedback may improve asthma symptom control in children, as well as caregiver quality of life, according to a randomized trial evaluating a sensor-based electronic monitoring system. Such a system would work well in racially and economically diverse pediatric populations, researchers found. However, this intervention was also associated with higher health care usage, suggesting that further “platform refinement” is warranted. The study, from Ruchi S. Gupta, MD, MPH, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, and colleagues, was published in Pediatrics. One of the issues associated with managing asthma in school aged children is adherence to preventive therapies such as daily inhaled corticosteroids (ICS) — And poor adherence leads to complications. For example, research shows that about 1 out of every 4 asthma exacerbations and more than half of asthma-related hospitalizations are due to nonadherence to ICS. The need to improve ICS adherence among children has resulted in interventions involving sensor-based inhaler monitoring, giving clinicians the chance to assess and intervene on the basis of real-time adherence and usage data. Furthermore, Gupta and colleagues pointed out, “the integration of sensor-based inhaler monitoring with mobile applications may reduce asthma-related health care use by assisting asthma patients between health care provider visits.” The Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial was designed to determine the effectiveness of clinically-integrated, sensor-based inhaler monitoring on symptom control and outcomes in racially and socioeconomically diverse children with moderate-to-severe asthma. Children were eligible for inclusion in the study if they were 4 to 17 years of age, had moderate-to-severe persistent asthma, had a prescription for daily ICS for 1 or more years before enrollment, and at least 1 exacerbation requiring oral corticosteroids the year before trial enrollment. In this study, 125 caregiver and child pairs were randomly assigned to inhaler sensors that allowed for caregiver and clinician electronic monitoring of medications, while 127 pairs served as controls. One primary end point of the study was the change in asthma symptom control as measured by the Asthma Control Test (ACT), a five-item questionnaire, with scores ranging from a low of 5 for poorly controlled asthma, to 25 for well-controlled asthma, and the Childhood Asthma Control Test (c-ACT), a 7-item validated questionnaire for children aged 4 to 11 years, with scores ranging from 0 for poor asthma control to 27 for well-controlled asthma. Any score under 19 on either test indicated uncontrolled asthma. The other primary end point was health care usage, which included emergency department visits, hospitalizations, and oral corticosteroid prescriptions during the course of the 12-month trial. Daily ICS use and caregiver quality of life (QoL) were also assessed. Gupta and colleague found that by the end of the trial the mean adjusted ACT scores increased from 19.1 to 21.8 in the intervention group (a 2.7-point increase), and from 19.4 to 19.9 in the control group (a .5 point increase). They also found the change in adjusted mean ACT scores from baseline was significantly greater in the intervention group than in controls at all time points of the trial, with the greatest difference at 12 months.

Grant Issued to Develop Vaccine

JAN 11 2021

GeoVax Labs, Inc., a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the company a Small Business Innovative Research (SBIR) grant in support of its development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The Phase 1 grant, titled, “Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19,” will support the ongoing design, construction and preclinical testing of GeoVax’s vaccine candidates in preparation for human clinical trials. The efficacy testing will be performed in collaboration with the University of Texas Medical Branch (UTMB). GeoVax is leveraging its GV-MVA-VLP platform to address the global need for an effective and safe SARS-CoV-2 vaccine. Unique among other vaccines under development, the experimental GeoVax candidates are specifically designed to provide a broader and more long-lived level of protective immunity against SARS-CoV-2 while avoiding the potential side effects that can limit vaccine utility and acceptance. GeoVax’s vaccine candidates will be tested for antigen expression and genetic stability under conditions designed to simulate those in manufacturing, which will demonstrate the likely suitability of each vaccine construct as a candidate for full-scale production and clinical testing. Mark Newman, Ph.D., GeoVax’s Chief Scientific Officer, commented, “The first generation of SARS-CoV-2 vaccines are based on the ‘Spike (S)’ protein and are designed to induce antibodies that block infection of human cells, an effect referred to as virus neutralization. The GV-MVA-VLP platform provides the opportunity to design and test vaccine candidates that differ significantly through the inclusion of multiple SARS-CoV-2 proteins that are presented to the immune system as virus-like particles (VLPs). Our goal is to safely increase vaccine potency and efficacy by inducing both neutralizing antibody and cellular immune responses to optimize the level of protection against existing and potential new variants of COVID as well as establish immunological memory to provide multi-year protection. Vaccines using the GV-MVA-VLP platform developed for other pathogens have proven to be efficacious with a single dose, having strong durability which would be a significant advantage for SARS-CoV-2 global vaccination campaigns.” David Dodd, GeoVax’s Chairman and CEO, added, “We are pleased to receive this Phase 1 SBIR funding award, which will supplement the internal resources allocated to our COVID-19 vaccine program and accelerate our progress toward human clinical trials. We appreciate and welcome this support from NIH/NIAID, which follows our signing of a Patent and Biological Materials License Agreement providing GeoVax with access to key NIAID patent rights, and which provides GeoVax with nonexclusive rights to develop, manufacture and commercialize our COVID-19 vaccine. While we continue to advance our COVID-19 vaccine program, we remain in discussions and negotiations related to additional funding support that will further accelerate our progress into clinical testing and supply chain preparation. We anticipate that additional vaccines, such as ours will be necessary against COVID-19, as well as potentially new strains and variants, requiring broader immune response, strong durability, exquisite safety within various cohort populations and minimal refrigeration for distribution and supply throughout the world. These attributes represent the focus of our overall ‘COVID-X’ vaccine program (think ‘COVID-20, -21’, etc.).”

Mercury Medical Announces New Director of Sales

JAN 11 2021

Mercury Medical, Inc., has announced the appointment of David L. McLaughlin as Director of Sales - Western Region. McLaughlin will be responsible for increasing the sales growth of Mercury's products in the Western United States and galvanizing the sales infrastructure to better serve this essential customer base. "We are delighted to have David join the company at this juncture. Our product pipeline in the critical care markets has never been stronger. David is an 18-year veteran in our industry and previously worked at Mercury Medical as a Territory Sales Manager before joining Edwards Lifesciences in 2010. David brings significant commercial experience to Mercury Medical, which will be of great benefit for our customers," said Executive Vice President - Sales and Marketing, Ray Mundy. While at Edwards Lifesciences, McLaughlin held various leadership positions and was instrumental in developing strategic methodologies for sales and clinical training. "I am honored again to be joining Mercury Medical as their Director of Sales - Western Region. My focus will be on doing what is best for our customers and providing leadership and enhanced training to the sales organization," said McLaughlin. Mercury Medical is a global provider of medical device systems for healthcare providers bringing a legacy of innovation through high quality, cost-efficient solutions for better patient outcomes. As both a manufacturer and distributor, the company provides its products to critical care, neonatal, anesthesia, and EMS markets in more than 58 countries.

Company Signs Distribution Agreement

JAN 10 2021

Dräger, an international leader in the fields of medical and safety technology, today announced that it has entered into an agreement with Breas Medical, a global medical device company delivering respiratory care solutions throughout the continuum of care. Together, they will provide long-term acute care (LTAC) and skilled nursing facilities (SNF) in the US access to both Dräger and Breas Medical mechanical ventilator technologies. Both Dräger and Breas Medical offer solutions specifically designed to address the challenges faced by many LTACs and SNFs, most notably the complexity and costs associated with caring for chronically ill patients after requiring mechanical ventilation following intensive care. This new agreement with Breas Medical, effective January 6, 2021, will extend the reach of high-quality ventilation, along with the company’s unparalled service and support, into these and other non-acute settings. “In an effort to reduce costs, the care of stable but chronically ill patients is increasingly being pushed from the hospital out to extended care settings with many of these patients relying on mechanical ventilation,” said Dräger Senior Vice President of Sales, Hospital Solutions, Steve Menet. “Administrators at these alternative care facilities continue to deliver quality care with limited resources. This distribution agreement with Breas Medical offers a more comprehensive solution with the combined goals of positively impacting patient and financial outcomes.” “Quality and patient comfort are Breas’ top priority; we put great focus into these core values using innovation in all of our devices. This agreement with Dräger will improve the experience for patients, operators and clinicians while creating more effective access and support for Breas ventilators in the LTAC and SNF markets,” said Chris Southerland, General Manager of Commercial Operations, Americas Region at Breas Medical. “Dräger is known throughout the healthcare industry and respiratory community for its state-of-the art mechanical ventilation technology. We are proud to partner with Dräger in their efforts to care for more clinically complex patients.”

AerosoLess Medical Has Introduced a New Nebulizer Mask

JAN 8 2021

According to a recent estimate, more than 2,900 US healthcare workers have died in the COVID-19 Pandemic since March 2020. The gravity of the pandemic has heightened awareness of the necessity of preventing patients’ pathogens from infecting front-line medical personnel. In the case of nebulizers, which are the recommended treatment protocol for medical conditions where patients present with shortness of breath, the pandemic has compromised physicians’ options in treating their patients. Nebulizers are being underused due to concerns that they facilitate the spreading of patient-generated viral particles into the environment. AerosoLess Medical is producing the SafetyNeb, an aerosol delivery device fitted with water-resistant viral filters over its vent holes. These highly effective viral filters are designed to prevent both patient exhaled pathogens and fugitive emissions from entering into the environment and thereby endangering Healthcare Workers. In addition to the viral filters, the SafetyNeb uses patent-pending technology to create a CPAP-like tight seal with the patient’s face. Unlike other devices which were designed primarily for optimizing the delivery of aerosolized medications, the AerosoLess SafetyNeb was designed from the very beginning with the utmost focus on protecting the safety of healthcare personnel without compromising medication delivery. The unique design of the SafetyNeb drastically reduces the ability of pathogens contained in patients’ exhaled breath and coughs to escape into the environment

Capsule and Retia Medical Collaborate on Argos Cardiac Monitor

JAN 05 2021

Retia Medical is the first company to utilize Capsule Technologies’ new Device Driver Interface (DDI) development strategy to integrate its Argos Cardiac Monitor, the companies announced. Capsule’s new DDI development strategy uses the Integrating the Healthcare Enterprise-Patient Care Device (IHE-PCD) framework to speed device connectivity to other systems, improve clinician workflow efficiency, and to protect patient safety through rapid and accurate identification. IHE is a consortium of healthcare and industry experts focused on improving healthcare information sharing. The IHE framework fills the gaps between device communication standards such as HL7 without site-specific interface development so hospitals can more easily connect devices to their IT networks and capture data that drives safe and effective clinical decisions. “Medical devices, such as Retia Medical’s Argos Cardiac Monitor, are indispensable for delivering safe and high-quality patient care,” said John McHutcheon, vice president of operations at Capsule Technologies. “Yet effectively capturing and protecting the data generated from these life-saving devices, while enabling them to access EHR data, can be complicated. That is why we are very pleased to collaborate with Retia Medical on this first utilization of our Device Driver Interface that helps speed the development of highly interoperable, easily connected medical devices using an industry-recognized standard.” By leveraging the new DDI development strategy, Retia Medical expedited the integration of its updated Argos Cardiac Monitor, saving engineering time and improving customer satisfaction. Using this strategy also enables the Argos Cardiac Monitor to take advantage of Capsule Technologies’ Rapid Patient Identification (RPI) capability, which empowers clinicians at the point of care to more rapidly send patient demographic information to the device for faster identification confirmation, streamlining workflows, and promoting safer care. Likewise, the agreement with Capsule also supports Retia Medical’s ability to develop its device output following Rosetta Terminology Mapping (RTM) and to receive patient demographics on its device using an IHE Patient Demographics Query (PDQ) request. Incorporating RTM and IHE profiles improves the interoperability of Retia Medical’s device across a variety of different IT systems while also enabling clinicians to identify patients accurately and easily to protect their safety. “Our vision is to help prevent cardiovascular and other major complications from surgery and critical care by providing consistently accurate hemodynamic data to guide diagnosis and therapy. A key component of this approach is to help implement physiology-based, data-driven protocols through streamlined connectivity to the electronic health record (EHR) using modern communication protocols,” said Marc Zemel, co-founder and CEO of Retia Medical. “We are pleased to collaborate with Capsule to make this vision a reality.”