RT NEWS

New Tests May Finally Diagnose Long COVID

DEC 1 2023

One of the biggest challenges facing clinicians who treat long COVID is a lack of consensus when it comes to recognizing and diagnosing the condition. But a new study suggests testing for certain biomarkers may identify long COVID with accuracy approaching 80%. Effective diagnostic testing would be a game-changer in the long COVID fight, for it’s not just the fatigue, brain fog, heart palpitations, and other persistent symptoms that affect patients. Two out of three people with long COVID also suffer mental health challenges like depression and anxiety. Some patients say their symptoms are not taken seriously by their doctors. And as many as 12% of long COVID patients are unemployed because of the severity of their illness and their employers may be skeptical of their condition. Quick, accurate diagnosis would eliminate all that. Now a new preprint study suggests that the elevation of certain immune system proteins are a commonality in long COVID patients and identifying them may be an accurate way to diagnose the condition. Researchers at Cardiff University School of Medicine in Cardiff, Wales, United Kingdom, tracked 166 patients, 79 of whom had been diagnosed with long COVID and 87 who had not. All participants had recovered from a severe bout of acute COVID-19. In an analysis of the blood plasma of the study participants, researchers found elevated levels of certain components. Four proteins in particular — Ba, iC3b, C5a, and TCC — predicted the presence of long COVID with 78.5% accuracy. "I was gobsmacked by the results. We’re seeing a massive dysregulation in those four biomarkers," says study author Wioleta Zelek, PhD, a research fellow at Cardiff University. "It’s a combination that we showed was predictive of long COVID." The study revealed that long COVID was associated with inflammation of the immune system causing these complement proteins to remain dysregulated. Proteins like C3, C4, and C5 are important parts of the immune system because they recruit phagocytes, cells that attack and engulf bacteria and viruses at the site of infection to destroy pathogens like SARS-coV-2. In the case of long COVID, these proteins remain chronically elevated. While the symptoms of long COVID have seemed largely unrelated to one another, researchers point to elevated inflammation as a connecting factor that causes various systems in the body to go haywire. "Anything that could help to better diagnose patients with long COVID is research we’re greatly appreciative of within the clinical community," said Nisha Viswanathan, MD, director of the University of California Los Angeles Long COVID program at UCLA Health in Los Angeles. Testing for biomarkers highlighted in the study, as well as others like serotonin and cortisol, may help doctors separate patients who have long COVID from patients who have similar symptoms caused by other conditions, said Viswanathan. For example, a recent study published in the journal Cell found lower serotonin levels in long COVID patients compared with patients who were diagnosed with acute COVID-19 but recovered from the condition.

Air in Remote First Nations Houses Tied to Respiratory Ills

DEC 1 2023

Indoor air in four First Nations communities in remote northwestern Ontario contains high concentrations of biocontaminants, mold, fine particles, and other substances that increase the risk of respiratory infections, new research reveals. In a study of the housing conditions and indoor environmental quality (IEQ) in these communities, about 27% of the homes had sustained CO2 concentrations above 1500 ppm. Although 44% of houses had a heat recovery ventilator (HRV), only 8% were in good working condition. Other issues included biocontaminants such as dust mites and fungal glucan, tobacco smoking, and high concentrations of mold. "One exposure that led up to the children going to hospital was the chemical called endotoxin," study author J. David Miller, PhD, research professor at Carleton University in Ottawa, Ontario, said. "When concentrations are too high, it affects lung function and causes a greater response to allergens. The values in the Sioux Lookout Zone were around 1000 times higher than I'd ever seen in any study in the United States or Canada. That was a big surprise." In their study of four First Nations communities in a remote region of northwestern Ontario, the investigators used statistical methods such as linear regression, mixed models, and logistic regression to assess correlations between housing conditions and biocontaminants and indoor concentrations of fine inhalable particles (PM2.5), CO2, benzene, and formaldehyde.

They investigated 101 homes (40%) in these small communities; each had approximately 1200 residents. Samples were taken, and the homes were inspected by an indoor air quality specialist. To identify factors affecting IEQ, the investigators considered various issues. For example, the houses were crowded, averaging approximately seven people in each. The most common type of fuel for heating was wood (48%), but only 10% of the wood stoves were certified by the US Environmental Protection Agency (EPA) for lower emissions. In 94% of the houses, people smoked commercial tobacco. The mean number of smokers per house was 2.6, and the number of smokers per house was as high as seven.

AHA, AAP Update Neonatal Resuscitation Guidelines

DEC 1 2023

The American Heart Association (AHA) and American Academy of Pediatrics (AAP) have issued a focused update to the 2020 neonatal resuscitation guidelines. The 2023 focused update was prompted by four systematic literature reviews by the International Liaison Committee on Resuscitation (ILCOR) Neonatal Life Support Task Force. "Evidence evaluations by the ILCOR play a large role in the group's process and timing of updates," Henry Lee, MD, co-chair of the writing group, said. He noted that updated recommendations do not change prior recommendations from the 2020 guidelines. "However, they provide additional details to consider in neonatal resuscitation that could lead to changes in some practice in various settings," said Lee, medical director of the University of California San Diego neonatal intensive care unit. Lee noted that effective positive-pressure ventilation (PPV) is the priority in newborn infants who need support after birth. And while the 2020 update provided some details on devices to be used for PPV, the 2023 focused update gives guidance on use of T-piece resuscitators for providing PPV, which may be particularly helpful for preterm infants, and the use of supraglottic airways as a primary interface to deliver PPV, he explained. Specifically, the updated guidelines state that use of a T-piece resuscitator to deliver PPV is preferred to the use of a self-inflating bag. Because both T-piece resuscitators and flow-inflating bags require a compressed gas source to function, a self-inflating bag should be available as a backup in the event of compressed gas failure when using either of these devices. Use of a supraglottic airway may be considered as the primary interface to administer PPV instead of a face mask for newborn infants delivered at 34 0/7 weeks' gestation or later.

COVID-19 Antivirals Can Trigger Viral Rebound, Study Finds

NOV 16 2023

COVID-19 antivirals can trigger viral rebound in ambulatory patients, according to an analysis published in Annals of Internal Medicine. An observational cohort study compared patients with acute COVID-19 who received 5 days of nirmatrelvir-ritonavir (N-R [Paxlovid]; n = 72) to similar patients who did not receive the treatment (n = 55). All patients were seen in ambulatory settings. Researchers compared rates of reinfection, which was defined as an initial positive test followed by a negative result and then another positive result within 20 days. Rates of increased viral shedding were compared between the two groups as another measure of viral rebound. One in 5 people (15 in 72, 20%) who took N-R had viral rebound compared with just 1 in 55 people who did not. Those who took N-R were older, more likely to be immunocompromised, and had received a greater number of COVID-19 vaccinations (four on average) than did people who did not receive it (three on average). Eight of the 16 people with viral rebound also reported symptom rebound, and two were completely asymptomatic. People who had received N-R and eventually experienced a rebound showed viral shedding for a median of 14 days compared with a median of 3 days among people who did not rebound who were also taking the drug. "For patients with COVID-19 with a low-risk for severe disease, the possibility of prolonged shedding should be factored into the consideration of potential risks and benefits of treatment," the researchers write.

Pfizer, BioNtech Say Flu-COVID Shot Generates Strong Immune Response in Trial

OCT 30 2023

Pfizer and German partner BioNTech said that their vaccine to prevent flu and COVID-19 generated a strong immune response against strains of the viruses in an early- to mid-stage trial. The companies said they plan to start a late-stage trial in the coming months. "This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices," Annaliesa Anderson, Pfizer's head of vaccine research and development, said in a statement. In the trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies' updated COVID-19 vaccine given at the same visit. The data from the trial showed that the flu-COVID vaccine demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains, the companies said.

React Health Partners with EnsoData to Utilize Predictive AI to Improve Outcomes for Patients with Sleep Apnea

OCT 26 2023

EnsoData, a leading provider of artificial intelligence (AI) solutions to assist with sleep testing, diagnosis, and treatment, and React Health, a sleep and respiratory device manufacturer based in Sarasota, FL, announced a strategic collaboration to optimize PAP adherence support for patients with sleep apnea. EnsoData’s revolutionary adherence prediction AI will be integrated into React Health’s recently launched React Health Connect platform. This collaboration will empower referring physicians and DME suppliers with actionable data to provide timely, personalized support to patients who are struggling with therapy adherence. “By partnering with EnsoData, we are making another significant investment in our sleep therapy product portfolio”, says Tom Pontzius, President at React Health. “EnsoData’s predictive analytics will allow our customers to prioritize and focus on the patients that need intervention the most, and will ultimately provide a more personalized and positive patient experience.” “Our PAP compliance AI model has an incredible ability to predict compliance within days of starting treatment,” states Chris Fernandez, Chief Research Officer. “We are excited about the transformative impact our technology can have on the multitude of patients who face challenges in treating their sleep apnea. Our goal is to strengthen the bond between healthcare providers and patients, resulting in improved patient outcomes.” This partnership signifies a new era in personalized sleep apnea care where predictive clinical AI tools enable timely patient care, increased patient support, and stronger provider-patient connection.

Company Opens New Headquarters

OCT 24 2023

Leading global manufacturer of oxygen therapy and cardiorespiratory diagnostic equipment, CAIRE Inc. has opened the doors on its new Global Service Headquarters in Canton, GA, in a location near its primary manufacturing hub north of Atlanta. The move by the company is designed to advance long-term plans to enhance service and support for home and durable medical equipment providers everywhere. The 29,500-square-foot Canton facility will provide rapid servicing of equipment, as well as fulfillment of specialty service parts and accessories for CAIRE respiratory and specific AirSep brand commercial products. The site has 20 employees, inclusive of the company’s US-based technical service team who primarily supports respiratory product customers and end users. The opening, combined with the recent expansion of CAIRE’s Authorized Service Network to 23 locations nationwide, is expected to streamline how customers receive critical support to equip their technical service teams with the products they need, and also maintain equipment fleets more efficiently. “As we navigated the challenges of the pandemic, we discovered there was an opportunity to improve the efficiency of our service and support infrastructure. By separating our after-market support from our manufacturing facility, we have the ability to improve the quality and MR-CORP0025 A efficiency of after-market service, and at the same time we can leverage the national footprint and expertise of our Authorized Service Network to serve our customers closer to home which is a win-win for everyone,” said Barry Hassett, Chief Commercial Officer. CAIRE’s Authorized Service Network, focused on in-warranty product repairs, includes Altra Services Professionals, Oxygen Sales & Service, Inc., Quality Biomedical, and Repair Authority. These providers not only offer convenient physical locations, but several also offer multi-state pick-up and delivery services as an added benefit to customers. “The organizations that make up our Authorized Service Networks have been essential partners in supporting the nation’s largest medical equipment providers during a period of serving a large and ever-growing population of oxygen patients. Through our partnership, CAIRE’s customers have a wider pool of service professionals that can shorten lead times and deliver potential savings on shipping and freight,” said Lanier Hogan, Global Parts and Service Manager.

Telesair Receives FDA Clearance for Bonhawa High Flow Oxygen Therapy System

OCT 17 2023

Telesair, Inc., a technology leader in the respiratory industry, announced that it has received FDA clearance to market its Bonhawa High Flow Oxygen Therapy (HFOT) system, designed to enhance the treatment of patients with respiratory insufficiency. Bonhawa is now the only purpose-built high flow system to receive both the CE Mark/European Medical Device Regulation and FDA 510(k) clearance. Bonhawa gives healthcare providers and their patients in the US and worldwide an extended flow range, a streamlined disinfection process and an intuitive touchscreen. These attributes collectively offer healthcare workers and institutions greater capabilities and efficiencies. “The best in class Bonhawa system greatly improves patient care while enhancing efficiency for clinicians,” said Bryan Liu, PhD, CEO of Telesair. “It represents a significant milestone in that it is a more cost-effective, user-friendly option for treating respiratory conditions. Bonhawa is the only standalone high flow oxygen therapy system designed by experts in ventilation. Our team has decades of experience developing and commercializing revolutionary respiratory solutions and collaborated to create this efficient, easy-to-use system. I am very proud of the organization for achieving both MDR/CE and FDA clearance in less than one year.” Telesair’s introduction of its lightweight oxygen therapy system to the US further expands the company’s existing market access that includes Europe, Latin America, Asia and the Middle East. Liu added that Telesair is actively engaged in developing its first-in-class next-generation home-based platform and is confident in its ability to swiftly introduce its revolutionary technology to the market.

Company Signs Contract for Device

OCT 16 2023

Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd.), announced that the LungFit PH system has received an Innovative Technology contract from Vizient, Inc., the nation’s largest provider-driven health care performance improvement company. The contract was awarded based on the recommendation of the LungFit PH system by hospital experts who serve on one of Vizient’s customer-led councils, and it signifies to Vizient customers unique qualities that potentially bring improvement to the health care industry. Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient’s Innovative Technology Program. Vizient customer-led councils identify technologies that have the potential to enhance clinical care, patient safety, health care worker safety or improve business operations of health care organizations. Approved in June 2022, LungFit PH is the first and only 3-in-1 integrated system for inhaled nitric oxide (iNO) generation, delivery, and monitoring, providing unlimited on-demand iNO regardless of set dose or ventilator flow. LungFit PH employs patented Ionizer™ technology to generate iNO from room air within seconds, providing unprecedented speed to care. This point-of-care solution alleviates the logistical and supply challenges associated with traditional iNO systems by streamlining inventory management with a predictable, on-demand supply of iNO generated at the bedside. Clinicians generate what they need whenever they need it. This innovative system is paired with an all-inclusive 24/7 service and support program designed to exceed customer expectations.

“We’re very happy and honored to be awarded an Innovative Technology contract from Vizient for our LungFit device. This validates the customer experience and feedback we have received to date,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Our revolutionary generator-based delivery system is a transformative technology with the potential to change how nitric oxide is used to the benefit of both patients and hospitals, and we are very excited by this opportunity to expand our reach through the robust Vizient customer network.” “Congratulations to Beyond Air for being awarded an Innovative Technology contract,” said Kelly Flaharty, senior director of contract services for Vizient. “Our member council recommended the LungFit PH system for this contract based on the efficiencies it offers and its potential to make an incremental difference in health care.” Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents more than $130 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with hospital experts on its customer-led councils and task forces to evaluate products for their potential to bring real innovation to health care. Vizient may award a contract to products deemed worthy of the Innovative Technology designation outside of the competitive bid cycle.

Masimo ORi Granted De Novo as the First and Only FDA-Cleared Noninvasive and Continuous Parameter

OCT 13 2023

Masimo announced that ORi, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA. Enabled by the multi-wavelength Masimo rainbow Pulse CO-Oximetry platform, ORi is designed for use in conjunction with oxygen saturation (SpO2) to provide increased resolution of changes in oxygenation under supplemental oxygen. With the De Novo, ORi becomes the first-of-its-kind parameter cleared by the FDA to help clinicians manage oxygen of adults undergoing surgery in perioperative hospital environments. Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood. There is growing evidence that hyperoxia is harmful and can lead to oxygen toxicity, causing oxygen poisoning or pulmonary tissue damage.1 Currently, clinicians take blood draws that are analyzed to determine PaO2 levels, the partial pressure of oxygen measured by arterial blood gas devices. However, arterial blood analyses are both intermittent and delayed – leaving clinicians blind to the changes in oxygenation occurring between blood draw results. Masimo ORi addresses these shortcomings by providing continuous insight into the oxygenation of hemoglobin in the moderate hyperoxic range (PaO2 > 100 and ≤ 250 mmHg). ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of the oxygenation of patients beyond SpO2 under supplemental oxygen. By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered. ORi provides clinicians with additional visibility, as a complement to Masimo SET® pulse oximetry, into when oxygenation is increased into, or decreased out of, moderate hyperoxia, in real time. Numerous studies have demonstrated ORi’s utility. For example, in a study published in Anesthesia & Analgesia of 106 adult patients undergoing scheduled surgery, researchers found decreases in ORi “may provide advance indication of falling PaO2 when SpO2 is still > 98%.” In another study published in Intensive Care Medicine, researchers found that the use of ORi monitoring to titrate oxygen rates “allowed an important reduction of the time spent with hyperoxia compared with the use of SpO2 alone,” in a group of 150 mechanically ventilated adult patients randomized to an ORi or a control group. Joe Kiani, Founder and CEO of Masimo, said, “Since ORi’s availability and success outside the U.S., perioperative clinicians in the U.S. have been waiting for a way to noninvasively monitor patients under supplemental oxygen beyond the limits of SpO2. We are thrilled that U.S. clinicians can now integrate ORi monitoring – available now on our rainbow SET platform – into their oxygenation monitoring practices, alongside Masimo SET Measure through Motion and Low Perfusion pulse oximetry, and experience their combined benefits.” Jesse M. Ehrenfeld, MD, President of the American Medical Association and advisor to Masimo, commented, “I can envision a number of scenarios I encounter in my daily clinical practice as an anesthesiologist where ORi would be invaluable. During patient pre-oxygenation, I often find myself unsure of the adequacy of pre-oxygenation, especially in a patient with a significant cardiopulmonary comorbidity or a patient with diminished oxygen reserve capacity. ORi would solve this problem by giving an easy-to-understand parameter that provides visibility to how oxygenation is changing during the pre-oxygenation process. Additionally, I often find that during the management of a difficult airway, it is never quite clear when to stop, re-establish mask ventilation, and allow the patient to recover. Again, ORi would be very helpful in addressing this issue as it can track the trajectory of the patient’s oxygenation status. I am delighted to see ORi receive FDA clearance. It is not often that new parameters are developed which can actually make a real impact in clinical practice.” Richard L. Applegate II, MD, Chair of Anesthesiology at Loma Linda University Health, California, stated, “Our studies show that ORi provides advanced detection of low SpO2 events. This additional time may allow modification of airway management, earlier calls for help, or assistance from other providers. Advanced detection of worsening oxygenation is valuable in operative and critical care settings and ORi use has the potential to provide continuous monitoring to detect changes in pulmonary function.” Ken B. Johnson, MD, Professor of Anesthesiology, University of Utah, commented, “I have been eager for the ORi parameter to be available in the US for a long time as it is a unique innovation with the potential to significantly improve patient care. Observing the ORi trend may help clinicians anticipate hemoglobin oxygen desaturations before they occur. Clinical scenarios where this technology may be useful include airway management that takes longer than expected, prompting rescue breaths before desaturation occurs, and procedural sedation with unanticipated prolonged periods of apnea that can trigger rescue maneuvers before the onset of unwanted desaturation. This index in combination with pulse oximetry shows promise in better managing adverse events related to poor oxygenation and improved patient outcomes.” ORi is granted a De Novo by the US FDA to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to administration of supplemental oxygen). The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.

New RSV Vaccine Will Cut Hospitalizations, Study Shows

OCT 13 2023

The newly approved respiratory syncytial virus vaccine administered during pregnancy substantially reduces the clinical and economic burden of lower respiratory tract disease caused by RSV, according to research presented at Infectious Disease Week (IDWeek) 2023 Annual Meeting. "With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total," presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing. "RSV is associated with a significant burden in the US and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden," Law explained. This study is "particularly timely as we head into RSV peak season," said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, Division of Pediatric Infectious Diseases at Vanderbilt University in Nashville, Tennessee. The challenge, said Halasa, is that uptake of maternal vaccines and vaccines in general is "not optimal," making increased awareness of this new maternal RSV vaccine important.

Pneumonia, Not Just Inflammation, May Cause Severe COVID

OCT 13 2023

Many researchers and doctors believe inflammation is the cause of severe COVID. This is due to the virus causing a "cytokine storm" that can adversely affect the organs in a patient's body, including the heart and lungs. New research from Northwestern University and the University of Wisconsin, however, is pointing to bacterial pneumonia as the cause of many severe COVID deaths. Deceased COVID patients studied were not shown to have experienced inflammation at all. Instead, the researchers, using machine learning to analyze data, found that half of the severely ill COVID patients who required a ventilator had bacterial pneumonia as a secondary infection. They did not find evidence of a cytokine storm in these patients; instead of dying from organ damage or failure due to COVID, they died of pneumonia. “Critically ill patients who recovered from pneumonia were more likely to live,” said Benjamin D. Singer, MD, senior author of the study, professor of pulmonary medicine, and a Northwestern Medicine pulmonary and critical care doctor in Chicago. Other researchers don’t debunk the idea of cytokine storms in COVID, however. Cytokines are chemicals that are released when a person’s immune system overreacts to an infection. Too many cytokines are toxic and can cause organ failure. In COVID-19, cytokines have been thought to release inflammation that can circulate through the body and cause death.

FDA Clears Nova’s Stat Profile Prime Plus Analyzer for Micro Capillary Sample Mode

OCT 3 2023

Nova Biomedical announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for a micro capillary sample mode on the Stat Profile Prime Plus Critical Care analyzer. Prime Plus now performs an 11-test panel including pH, PCO2, PO2, Na, K, iCa, iMg, Cl, glucose, lactate, and hematocrit with just 90 microliters of capillary blood, or a complete 22-test profile on just 135 microliters of blood. The micro capillary sampling mode adds to Prime Plus blood conservation capabilities for critical care diagnostic testing and is available as a standard feature on all Prime Plus analyzers. Stat Profile Prime Plus provides the most modern and clinically effective critical care test menu including pH, PCO2, PO2, SO2%, Na, K, iCa, iMg, Cl, TCO2, glucose, lactate, creatinine, urea, hematocrit, hemoglobin, MCHC, estimated plasma volume, CO-Oximetry panel, and 34 calculated results in a simple, compact analyzer. Prime Plus combines maintenance-free, replaceable cartridge technology for sensors and reagents with patented, maintenance-free, whole blood CO-Oximetry technology. Blood loss for laboratory testing of critically ill patients has been shown to be a major contributor to severe anemia and increased administration of blood products, which is furthermore associated with prolonged hospital stay and increased mortality rate. According to Terry Austin, Sales Product Line Manager for Prime Plus analyzer, “Prime Plus microsample volume and comprehensive test menu provide a major blood-saving benefit for diagnostic testing of critically ill patients. Prime Plus delivers gases, electrolytes, glucose, lactate, hematocrit, or any subset of these tests on just two drops (90 microliters) of blood. A basic metabolic panel of electrolytes, glucose, lactate, creatinine, urea, and hematocrit is available on 135 microliters, 1/50th the volume of blood needed for the same tests in the central laboratory.” The use of small-volume microcapillary blood collection tubes with Prime Plus eliminates sample overdraws, dead volume, and sample waste of syringe or vacuum tube devices. Prime Plus comprehensive test menu enables scheduled bundling of tests to eliminate multiple sample draws, use of multiple sample containers, and amount of blood drawn for critical care testing.

New Data Lowers Estimate of Long COVID's Impact: CDC

OCT 2 2023

An estimated 18 million adults in the U.S. have had long COVID, and half of them are still dealing with the condition, new national survey data shows. Results from the CDC’s National Health Interview Survey in 2022 found that 6.9% of adults self-reported they had COVID symptoms for at least 3 months after testing positive or being diagnosed by a doctor as having COVID-19. The estimate is much lower than previous CDC survey data, which has consistently reported that approximately 14% to 15% of U.S. adults have had long COVID. The CDC also newly reported that 1.3% of U.S. children have had long COVID, and 0.5% of children having symptoms lasting at least 3 months at the time of the survey in 2022. The agency lists 19 possible long COVID symptoms, including fatigue, shortness of breath, a pounding heart, brain fog, and changes in smell or taste, as well as symptoms worsening with physical or mental effort. The 2022 survey results were analyzed by demographic factors such as income, gender, age, and race or ethnicity to see if groups of people are affected differently by long COVID. Wealthy people were the least likely to report having long COVID, while people whose family incomes were well below the federal poverty level were the most likely to have long COVID. Women were more likely than men to ever have long COVID or currently have the condition. People ages 35 to 49 years old were most likely to report having the condition.

Pneumonia, Not Just Inflammation, May Cause Severe COVID

OCT 2 2023

As we continue to live with COVID-19, patients and doctors will learn more about the reasons infections can range from asymptomatic to very serious. Many researchers and doctors believe inflammation is the cause of severe COVID. This is due to the virus causing a "cytokine storm" that can adversely affect the organs in a patient's body, including the heart and lungs. New research from Northwestern University and the University of Wisconsin, however, is pointing to bacterial pneumonia as the cause of many severe COVID deaths. Deceased COVID patients studied were not shown to have experienced inflammation at all. Instead, the researchers, using machine learning to analyze data, found that half of the severely ill COVID patients who required a ventilator had bacterial pneumonia as a secondary infection. They did not find evidence of a cytokine storm in these patients; instead of dying from organ damage or failure due to COVID, they died of pneumonia. Critically ill patients who recovered from pneumonia were more likely to live,” said Benjamin D. Singer, MD, senior author of the study, professor of pulmonary medicine, and a Northwestern Medicine pulmonary and critical care doctor in Chicago. Other researchers don’t debunk the idea of cytokine storms in COVID, however. Cytokines are chemicals that are released when a person’s immune system overreacts to an infection. Too many cytokines are toxic and can cause organ failure. In COVID-19, cytokines have been thought to release inflammation that can circulate through the body and cause death.

Pilot Study demonstrates Vapotherm HVNI technology is more effective than standard oxygen therapy

SEP 26 2023

Vapotherm, Inc., a global medical technology company 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, today announced the presentation of an Investigator-initiated clinical trial, “High flow humidified oxygen as an early intervention in children with acute severe asthma - a feasibility randomized controlled trial” at the European Respiratory Society International Congress 2023. The study was conducted through the Brighton and Sussex Clinical Trial Unit at University Hospitals, Sussex, England under the direction of Drs Hector Rojas-Anaya and Paul Seddon. Children who presented to the Emergency Department with acute, severe, asthma exacerbations that did not respond to initial pharmacologic treatment were randomized to either HVNI or standard nasal oxygen therapy. Eighty-six percent (19/22) of children treated with standard oxygen required escalation of therapy, while only 61% (17/28) of children treated with HVNI needed further escalation. In addition, children treated with HVNI met hospital discharge criteria in a median time of 29 hours, compared to a median time of 37 hours for those treated with standard oxygen. “Anytime a child with severe asthma can get well faster and avoid more invasive care it is a victory. We are excited and proud that our technology was utilized in this study and in the care of these children.” said Dr Jessica Whittle, Chief Medical Officer of Vapotherm. Almost 5 million children in the USA, and 1 million children in the UK have asthma, according to the CDC and NHS. Asthma is estimated to cost $56 billion according to the Asthma and Allergy Foundation of America. Studies of acute asthma and other emergent conditions are limited, in part, by the challenge of obtaining informed consent. This study demonstrated the feasibility of pediatric emergency studies utilizing coordinated care and delayed informed consent. “These numbers show that we have an enormous opportunity to help children all over world breathe better and have better lives with our technology,” said Joe Army, CEO of Vapotherm.

SGLT2-inhibitors: No Benefit in Hospitalized COVID-19

SEP 15 2023

A new meta-analysis has shown that SGLT2 inhibitors do not lead to lower 28-day all-cause mortality compared with usual care or placebo in patients hospitalized with COVID-19. However, no major safety issues were identified with the use of SGLT2 inhibitors in these acutely ill patients, the researchers report. "While these findings do not support the use of SGLT2-inhibitors as standard of care for patients hospitalized with COVID-19, I think the most important take home message here is that the use of these medications appears to be safe even in really acutely ill hospitalized patients," lead investigator of the meta-analysis, Mikhail Kosiborod, MD, Saint Luke's Mid America Heart Institute, Kansas City, Missouri, concluded. He said this was important because the list of indications for SGLT2 inhibitors is rapidly growing. "These medications are being used in more and more patients. And we know that when we discontinue medications in the hospital they frequently don’t get restarted, which can lead to real risks if SGLT2 inhibitors are stopped in patients with heart failure, chronic kidney disease or diabetes. So, the bottom line is that there is no compelling reason to stop these medications in the hospital," he added. The new meta-analysis was presented at the recent European Society of Cardiology (ESC) Congress 2023, held in Amsterdam, the Netherlands. Discussant of the presentation at the ESC Hotline session, Muthiah Vaduganathan, MD, MPH, Brigham and Women’s Hospital, Boston, Massachusetts, agreed with Kosiborod's interpretation. "Until today we have had very limited information on the safety of SGLT2-inhibitors in acute illness, as the pivotal trials which established the use of these drugs in diabetes and chronic kidney disease largely excluded patients who were hospitalized," Vaduganathan said. "While the overall results of this meta-analysis are neutral and SGLT2 inhibitors will not be added as drugs to be used in the primary care of patients with COVID-19, it certainly sends a strong message of safety in acutely ill patients," he added. Vaduganathan explained that from the beginning of the COVID-19 pandemic there was great interest in repurposing established therapies for alternative indications for their use in the management of COVID-19.

Mepolizumab Improves Asthma After 1 Year Despite Comorbidities

SEP 15 2023

Adults with asthma who were newly prescribed mepolizumab showed significant improvement in symptoms after 1 year regardless of comorbidities, based on data from 822 individuals. Comorbidities including chronic rhinosinusitis with polyps (CRSwNP), gastroesophageal reflux disease GERD), anxiety and depression, and chronic obstructive pulmonary disorder (COPD) are common in patients with severe asthma and add to the disease burden, wrote Mark C. Liu, MD, of Johns Hopkins University, Baltimore, and colleagues. “Some comorbidities, such as CRSwNP, share pathophysiological mechanisms with severe asthma, with interleukin-5 (IL-5),” and treatments targeting IL-5 could improve outcomes, they said. In the real-world REALITI-A study, mepolizumab, a humanized monoclonal antibody that targets IL-5, significantly reduced asthma exacerbation and oral corticosteroid use in severe asthma patients, they said. To assess the impact of mepolizumab on patients with comorbidities, the researchers conducted a post hoc analysis of 822 adults with severe asthma, including 321 with CRSwNP, 309 with GERD, 203 with depression/anxiety, and 81 with COPD. The findings were published in the Journal of Allergy and Clinical Immunology: In Practice. The main outcomes were the rate of clinically significant asthma exacerbations (CSEs) between the 12 months before and after mepolizumab initiation, and the changes from baseline in the daily maintenance use of oral corticosteroids (OCS). Across all comorbidities, the rate of CSEs decreased significantly from the pretreatment period to the follow-up period, from 4.28 events per year to 1.23 events per year. “A numerically greater reduction in the rate of CSEs was reported for patients with versus without CRSwNP, whereas the reverse was reported for patients with versus without COPD and depression/anxiety, although the confidence intervals were large for the with COPD subgroup,” the researchers wrote.

Shakeup in Pharmacy Market

SEP 8 2023

Monaghan Medical Corporation (Monaghan) and Allergan Sales, LLC have announced a mutual agreement wherein Monaghan will assume the direct management of the AeroChamber brand Valved Holding Chamber (VHC) for retail pharmacy markets. Starting January 1, 2024, Monaghan will take on the complete responsibility for retail pharmacy sales of the AeroChamber brand VHC. Commencing from September 1, 2023, Monaghan will initiate collaborations with pharmacy wholesalers and retail establishments that currently procure the AeroChamber brand VHC through Allergan, manufactured by Monaghan. Monaghan, headquartered in Plattsburgh, New York, is a prominent US-based manufacturer celebrated for crafting exceptional respiratory care products design specifically to treat respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and others. Monaghan’s excellence is rooted in innovative product development and design, underpinned by its world-class Aerosol and Research Laboratory.

Screening Finds High Rates of CVD in Diabetes, COPD Patients

AUG 30 2023

Systematic screening by primary care physicians for cardiovascular disease (CVD) in high-risk adults — those with type 2 diabetes, chronic obstructive pulmonary disease (COPD), or both — more than doubled the rate of incident CVD diagnosed compared with usual care in a Dutch study involving more than 1200 people and 25 primary care practices. Scaling up this program to larger populations could potentially uncover huge numbers of currently unrecognized people with CVD given the large number of adults with type 2 diabetes plus those with COPD, Amy Groenewegen, MD, said at the European Society of Cardiology Congress 2023. "I think this screening is ready for routine use, but it could be followed by prospective studies that investigate whether it produces more benefits in patient-centered outcomes," Groenewegen said in a press briefing. She stressed that it has not yet been clearly proven that patients with these chronic diseases are better off long term when their CVD is detected sooner using the tested approach. "We need simple ways to identify relevant patients for additional screening and potential treatment" of CVD, commented Lars Kober, MD, designated discussant at the Congress and a cardiologist and professor at Rigshospitalet, Copenhagen University Hospital, Denmark. The study is important because it tested a "very simple" symptom questionnaire as the initial screening phase, yet resulted in a CVD diagnostic rate that was two- to threefold higher than in the control patients managed with usual care, Kober noted.

The Reviving the Early Diagnosis of CVD (RED-CVD) trial randomized 14 primary care practices in the Netherlands to apply a structured screening protocol to adults with type 2 diabetes or COPD, and another 11 practices that served as controls and provided their patients with usual care. The study included 624 people in the screening arm and 592 in the usual-care arm. Their average age was about 68 years. In the screening arm, 87% had type 2 diabetes and 20% had COPD, including 6.3% with both. In the usual-care arm, 86% had type 2 diabetes, 21% had COPD, with 7.4% having both.

Generic Inhalers for COPD Support Hold Their Own

AUG 30 2023

A study published in the Annals of Internal Medicine finds that a generic maintenance inhaler is as effective at managing symptoms of chronic obstructive pulmonary disorder (COPD) as a pricier branded alternative. In 2019, the US Food and Drug Administration approved Wixela Inhub (the combination corticosteroid/long-acting beta-2 adrenergic agonist fluticasone–salmeterol; Viatris) as a generic dry powder inhaler for managing symptoms of COPD. This approval was based on evidence of the generic's effectiveness against asthma, although COPD also was on the product label. The study authors compared Wixela's effectiveness in controlling symptoms of COPD to that of the brand name inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline), which uses the same active ingredients. The result: "The generic looks to be as safe and effective as the brand name. I don't see a clinical reason why one would ever need to get the brand name over the generic version," said study author William Feldman, MD, DPhil, MPH, a health services researcher and pulmonologist at Harvard Medical School and Brigham and Women's Hospital in Boston. Feldman and colleagues compared the medical records of 10,000 patients with COPD who began using the branded inhaler to the records of another 10,000 patients with COPD who opted for the generic alternative. Participants in the two groups were evenly matched by age, sex, race, and ethnicity, region, severity of COPD, and presence of other comorbidities, according to the researchers. Participants were all older than age 40, and the average age in both groups was 72 years. The researchers looked for a difference in a first episode of a moderate exacerbation of COPD, defined as requiring a course of prednisone for 5-14 days. They also looked for cases of severe COPD exacerbation requiring hospitalization in the year after people began using either the generic or brand name inhaler. And they looked for differences across 1 year in rates of hospitalization for pneumonia. For none of those outcomes, however, did the type of inhaler appear to matter. Compared with the brand-name drug, using the generic was associated with nearly identical rates of moderate or severe COPD exacerbation (hazard ratio [HR], 0.97; 95% CI, 0.90 - 1.04. The same was true for the proportion of people who went to the hospital for pneumonia at least once (HR, 0.99; 95% CI, 0.86 - 1.15.

What Impact Do Changes to a Newborn's Microbiota Have?

AUG 30 2023

There's a lot at stake in the first few months of life, and our gut microbiota are no exception. A newborn and infant's microbiota are especially vulnerable to environmental threats. A stable ecosystem does not develop until the age of 2 or 3 years. In toddlers, pathogenesis in the microbiota is linked to the microbiota's immaturity and to dysbiosis (or imbalance of the microbiota), explained Aurélie Morand, MD, PhD, infectious diseases pediatrician at the Timone Hospital in Marseille, France (part of Marseille Public Hospitals), at a conference held by the French Pediatric Society. This dysbiosis, depending on the number and nature of environmental threats, will either be rapidly corrected or become long-lasting and lead to short- or long-term disease. "The dysbiosis of the microbiota plays a real role in short-term pathogenesis, such as in acute necrotizing enterocolitis in newborns and premature babies, in diarrhea occurring after a bout of gastroenteritis or alongside antibiotic use, in multidrug-resistant bacteria colonization, in susceptibility to infection (B Streptococcus, etc.), in colitis caused by C. difficile, and so forth," said Morand. "On a long-term basis, it is difficult to figure out the role of the microbiota in the onset of dysbiosis after antibiotic use, for example, and that of a subsequent pathology, from likely intertwined roles, as in inflammatory bowel disease (IBD), celiac disease, insulin resistance, obesity, atopic disorders, autoimmune conditions, and neuropsychiatric disorders, including autism and Parkinson's disease," she added. This finding is common to studies published on the topic: Microbiota immaturity is associated with an increased risk for infection in newborns. An example of this phenomenon is group B streptococcal meningitis in newborns. This disease is encouraged by gut colonization, immature intestinal mucosa, and microbiota that are unable to compete with infectious agents they encounter, stimulate junction proteins in the epithelial barrier, or even sufficiently activate the immune system. These factors make newborns especially susceptible to bacterial meningitis. Due to these gaps in their defenses and protective barriers, bacteria cross the epithelial barrier, pass into the bloodstream, and cross the blood-brain barrier.

Another textbook case is infant botulism, which is where the advice not to give honey to children under the age of 1 year comes in. The immaturity of an infant's gut microbiota allows colonization of the digestive tract with Clostridium botulinum after spores from the bacteria contained in honey, as well as from dust from our surroundings, are ingested. The germ then secretes toxins inside the digestive tract, which are spread via hematogenesis, potentially causing infant botulism.

Expert Calls for Sparing Use of Oxygen for Dyspnea in the Emergency Department

AUG 30 2023

Oxygen therapy is used too often in patients with respiratory difficulties, says one expert, and should only be given when oxygen saturation levels (SpO2) drop below 93%, as per the current guidelines. Florian Negrello, MD, an emergency medicine specialist at University Hospital of Martinique in Fort-de-France, reiterated this message at the 2023 conference held by France's emergency medicine society (Urgences 2023). The recommendation is intended to prevent hyperoxia; increasing evidence indicates the harmful effects of such a state on the body. "This is a real problem. Oxygen therapy is given all too readily despite studies now showing that excess oxygen is harmful, especially in patients with head trauma, ischemic stroke, or cardiac arrest," stated the session's moderator, Patrick Plaisance, MD, PhD, a doctor at Lariboisière Hospital in Paris. Described as difficulty breathing or shortness of breath, dyspnea is common in the emergency department, occurring in 5%-9% of patients. Close to 20% of intensive care unit admissions involve patients with dyspnea. "Since this is a very subjective symptom, it's possible it's being underdiagnosed," said Negrello.

Race-Specific Spirometry: No Benefit in CT or Dyspnea Models

AUG 30 2023

Use of race-specific spirometry equations yielded no significant improvement in models of lung function involving dyspnea and quantitative chest CT according to data from two population-based cohorts. Spirometry has traditionally included reference equations to estimate "normal" lung function that have included age, gender, height, and race/ethnicity, wrote Amy L. Non, PhD, of the University of California San Diego, La Jolla, and colleagues. Although the inclusion of race is based on population-wide studies showing lower measures of lung function for some racial and ethnic groups, the clinical value of the race element of these equations has been questioned, they said. In a study published in the journal Chest, the researchers used data from the National Health and Nutrition Survey (NHANES) between 2007 and 2012 and the COPDGene study. The researchers used a population of 3700 healthy, never-smoking adults from the NHANES cohort and 419 from the COPDGene cohort to create equations that excluded race as well as equations that were race-specific. The NHANES cohort demographic were 38% White, 21% Black,18% Mexican-American,13% other Hispanic, and 10% mixed race or "other" races. The COPDGene cohort was 18% Black and 82% White. The primary outcome was how effectively the percent predicted forced expiratory volume per 1 second (ppFEV1) values on the basis of race-specific, race-neutral, and race-free reference equations explained dyspnea, chest abnormalities on CT, or Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. In comparing the models of never-smokers, the race-specific equations showed no advantage over the equations that included race. "Race-neutral equations generated higher predicted FEV1 and [lower limit of normal] values than race-specific equations for the Black participants, but unchanged or minimally shifted to lower values in the White participants of both healthy, never-smoking cohorts," the researchers wrote. Among smokers, the race-neutral equations perpetuated a shift in ppFEV1 in the Black population to lower values and reclassified an average of 17.3% of Black smokers in the NHANES cohort into worse GOLD categories.

Device Approved for Patients

AUG 23 2023

Telesair, Inc., an innovator of next generation respiratory technology, announced that it has received CE (Conformité Européenne) Marking under the European Medical Device Regulation for its Bonhawa High Flow Oxygen Therapy (HFOT) system for use in the treatment of patients with respiratory insufficiency. The Bonhawa HFOT is one of the first respiratory therapeutic devices from a US based company to receive CE Mark under the new European Medical Device Regulation (EC/MDR), largely considered to be among the most difficult approvals in the world to achieve. The light and compact device features an extended flow range up to 80 L/pm, a simple disinfection process and an easy-to-use touchscreen, allowing greater therapeutic range, efficient disinfection, the potential to reduce the workload of caregivers, and the ability to visualize patient settings and data from outside the room. “Having our Bonhawa system approved for Europe is a major step in the evolution of Telesair as a company and opens the many markets which accept CE Mark,” said Bryan Liu, CEO of Telesair. “We were able to accomplish this goal in record time – less than 10 months – thanks to our combination of a great team of experienced professionals, genuinely innovative respiratory technology products, attention to detail, high-level process control, and exceptional value.” “We are already working on positioning our next generation home-based platform which we also intend to get approved swiftly,” added Liu. Telesair’s CE Mark and introduction of its lightweight oxygen therapy system to Europe further expands the company’s existing market access that includes Latin America and Southeast Asia.

Masimo Announces Full Market Release of Stork Smart Home Baby Monitor

AUG 23 2023

Masimo announced the full US market release of the Stork smart home baby monitoring system. Stork Vitals+, Vitals, and Camera combinations are now available for purchase online at www.MasimoStork.com and on shelves at major retailers including Best Buy and specialty retailers including Babylist. “We are delighted to bring Masimo Stork to parents and caregivers in the United States,” said Joe Kiani, Founder and CEO of Masimo. “With the launch of Stork, parents for the first time can have access to a technology originally developed for the most challenging patients in hospitals, with a user interface that is a simple and easy-to-use app on a phone.” The Stork smart home baby monitor represents a significant advancement in smart baby monitoring technology, providing parents and caregivers a continuous and accurate view of their baby’s health data. Leveraging Masimo’s revolutionary noninvasive hospital neonate monitoring technologies, Stork offers a range of innovative features, including: Continuous tracking of health data: Stork’s noninvasive sensing technology has been used by hospitals for more than 25 years and today monitors over 10 million babies around the world each year.1 Stork tracks health data such as pulse rate, oxygen saturation (SpO2), and temperature, helping give parents greater awareness of their baby. 2K quad high-definition (QHD) capable video: With crystal-clear video and audio streaming capabilities, parents can keep a close eye on their baby from anywhere, at any time, through the companion smartphone app. Parent-tested mobile app: The Stork app’s user-friendly interface allows parents to customize room condition alerts, view historical data, and receive notifications about the sensor’s status. Secure and encrypted connectivity: With its hospital roots, Masimo prioritizes the security and privacy of its users. The Stork baby monitor features AES-256 bit encryption to safeguard sensitive data. The Masimo Stork baby monitor system is comprised of several components and is available in multiple configurations. Masimo Stork Vitals+, the flagship solution, consists of a boot with sensor, video camera, and mobile app. The boot is made from an ultra-soft, comfortable medical-grade silicone that conforms gently to the baby’s foot and comes in three sizes to ensure a good fit and to accommodate babies up to 18 months old. The sensors embedded in the Stork boot are the product of meticulous engineering, harnessing Masimo’s decades of expertise in newborn monitoring to accurately and dependably detect babies’ pulse rate, SpO2, and temperature. Stork’s high-resolution camera provides outstanding nighttime vision and offers high-quality two-way audio through the camera, letting parents hear and talk to their babies as if they were right next to them. The camera is also equipped with room condition monitoring to accurately report room temperature and humidity. All components are connected to the Masimo Stork app, which allows parents to see their baby’s monitoring data, view summaries of averages and trends, and share photos with others. Stork has been designed to open up many more incredible features, to be made available in the future, some for free and some for additional cost. For consumers who do not require streaming video or want to extend baby tracking outside the home, the Stork Vitals solution replaces the camera with a health hub which connects the Stork boot and sensor to the Stork App, while still allowing parents to hear their baby and monitor room conditions. Masimo Stork is an ideal gift for new and expecting parents, for baby showers, or as a thoughtful gesture for those who want to track health data to get to know their baby better. The Masimo Stork system ranges from $249 to $549 USD. Masimo Stork is not sold as a medical device and should not be used for medical purposes.

New Study Finds That Masimo SedLine Patient State Index (PSi) Has the Potential to Improve Brain Monitoring for Patients Sedated with Dexmedetomidine

AUG 8 2023

Masimo announced the findings of a study published in Frontiers in Neuroscience in which Dr Lichy Han and colleagues at Stanford University evaluated the ability of Masimo SedLine brain function monitoring to assess the sedation levels of patients undergoing drug-induced sleep endoscopy (DISE) with dexmedetomidine – a sedative with numerous advantages. The researchers found that Masimo Patient State Index (PSi), a SedLine parameter derived from electroencephalographic (EEG) data, was statistically significantly associated with dexmedetomidine dosage, and, along with another EEG metric, “better captured changes in brain state from dexmedetomidine and ha[s] potential to improve the monitoring of dexmedetomidine sedation.” The researchers noted that while anesthesia induced with dexmedetomidine may more closely resemble natural sleep compared to other sedatives, which makes it particularly appropriate in procedures like DISE, its effects on the brain are inconsistent, which has limited its usage. Better sedation assessment – an improved understanding of its impact and corresponding EEG changes – could help support more widespread adoption of the drug. The researchers accordingly sought to compare and evaluate several methods of assessing sedation in such a scenario. Regarding the choice of EEG markers, they noted that “Previous EEG markers, such as the bispectral index, have been unable to determine differences elicited with dexmedetomidine (Kaskinoro et al., 2011), thus motivating the discovery of novel EEG markers associated with changes in brain state seen with dexmedetomidine sedation.” They enrolled 51 patients undergoing DISE, for the diagnosis and possible treatment of obstructive sleep apnea, who were sedated with dexmedetomidine and continuously monitored using Masimo SedLine. The concentration of the drug in their bloodstream was determined using a pharmacokinetic model. The concentration levels over time were recorded alongside the values derived from four methods of assessment, two metrics and two analyses: 1) the Richmond Agitation-Sedation Scale (RASS), 2) the SedLine Patient State Index (PSi), 3) spectral edge frequency (SEF95), the frequency below which 95% of total EEG power was contained, and 4) the correlation dimension (CD), a type of fractal dimension used to assess the complexity of a system. To evaluate the efficacy of these methods, the researchers compared them both against dexmedetomidine concentration and against each other. Comparing the assessment methods to dexmedetomidine concentration, the researchers observed that RASS scores decreased with increasing dexmedetomidine concentration but noted that, “Overall, the RASS score was least able to capture the brain state changes seen with dexmedetomidine, suggesting other metrics for titrating dexmedetomidine sedation may be of greater value.” They found that PSi, SEF95, and CD all decreased statistically significantly with increasing dexmedetomidine concentration (p < 0.001, p = 0.006, and p < 0.001, respectively), “a clear dose-dependent decrease with an inflection point.” Comparing the methods to each other, they found that PSi, SEF95, and CD all decreased statistically significantly with decreasing RASS score (p < 0.001, p < 0.001, and p = 0.02, respectively), most notably at deeper levels of sedation, suggesting that this is when they may be most beneficial. CD and SEF95 were statistically significantly correlated (p < 0.001, r = 0.515), but there was a subset of points that exhibited high SEF95 but low CD. PSi was most strongly correlated with SEF95 (p < 0.001, r = 0.631). The researchers concluded, “Complex EEG metrics such as PSi and CD, as compared to RASS score and SEF95, better captured changes in brain state from dexmedetomidine and have potential to improve the monitoring of dexmedetomidine sedation.” In their discussion, they noted that, “CD excelled at reflecting changes seen with rising dexmedetomidine concentration but appeared to exhibit a ceiling effect, whereas PSi had the most significant relationship with the RASS score. Both metrics were able to capture brain state changes corresponding to increased dexmedetomidine dose, showed decreased sensitivity to observer variability and artifact, and corresponded to currently used infusion dosages in pharmacokinetic simulations.” Study lead authors Lichy Han, MD, PhD and David Drover, MD, Perioperative and Pain Medicine at Stanford University, commented, “This study provides one more step in the journey to understanding SedLine processed EEG parameters that can guide sedation levels. In this case, dexmedetomidine, a widely used sedative, which has not been fully characterized by processed EEG, was titrated using standard indices PSi, SEF95, as well as fractal dimension (CD) commonly applied to time series data like EEG. In contrast to BIS, SedLine parameters (particularly PSi) were able to characterize processed EEG changes that correlated with dexmedetomidine sedation level and concentration, and these parameters correlated better than the subjective measure RASS (the most widely used clinical measure of sedation depth). This work helps clinicians use SedLine as an objective measure reflecting how the brain is responding to this important sedative, dexmedetomidine.”

Neotech Launches Tubing Holder

AUG 2 2023

Neotech Products announced the release of the NeoSnug Tubing Holder. NeoSnug helps prevent tubing from shifting or slipping. The NeoSnug’s unique, pre-cut shape goes under the nose and allows clinicians to secure the tubing close to the nares. Like several Neotech products, NeoSnug features a NeoBond Hydrocolloid base, which is less likely to irritate sensitive skin. The flap is engineered to hold securely and permanently. “Current common practice is to use multiple products to secure the NG tube; applying DuoDERM to the skin, then placing the tube, then laying TegadermT or Hypafix over that,” inventor Carol Herndon, BSN, RNC-NIC, said. “And nurses often hand-cut them to get the shape they need. I wanted a single use, all-in-one solution that was skin friendly, pre-cut, and extremely secure. The design also helps guard against the infant accidentally pulling out the tube.” The NeoSnug features: Skin friendly Hydrocolloid adhesive base; unique shape ideal for securing tubes close to the nares; fold over flap engineered to relieve stress on tubes and keep them securely in place; non-woven fabric contours to face or body; single patient use; and made in the USA.

Company Acquired

JULY 20 2023

Werfen announced that it has successfully completed the acquisition of Immucor, Inc., after obtaining all necessary regulatory and antitrust approvals. Immucor is a privately held, US-based company, in the in vitro diagnostics (IVD) sector, with a solid global presence in the Transfusion and Transplant markets. “During our more than 50-year history, we have demonstrated our strong commitment to expand our IVD business through organic growth, complemented with highly strategic acquisitions,” said Carlos Pascual, CEO of Werfen. The price of the acquisition was approximately US$2 billion, financed by a combination of cash on-hand and bank debt facilities, syndicated by 19 national and international entities, led by BBVA, BNP Paribas, CaixaBank and HSBC. As part of its credit management, Werfen plans to refinance part of the debt in the capital markets, as well as quickly reduce the level of indebtedness. Following the announcement of the acquisition, Standard & Poor’s affirmed Werfen’s investment grade rating (BBB-) with a stable outlook. With the integration of Immucor, Inc., Werfen expands its presence as a company of reference in the Specialized Diagnostics market and grows its portfolio of diagnostic solutions for hospitals and clinical laboratories. In addition, revenues will exceed €2.2 billion, and the Company will have seven technology centers and employ more than 7,000 people worldwide; with a direct presence in more than 30 countries and in more than 100 territories through distributors.

Siemens Healthineers launches Atellica CI Analyzer

JULY 20 2023

The newest addition to the Siemens Healthineers Atellica in vitro diagnostics portfolio, the Atellica CI Analyzer for immunoassay and clinical chemistry testing, has received FDA clearance and is now available in many of the world’s major markets. Labs operating at low to medium testing volumes will benefit from competitive advantages that the analyzer offers, including improved turnaround time predictability, advanced reporting functionality, and focused safety and security measures. Every lab, regardless of size, needs to tackle big challenges resulting from labor shortages—from producing test results reliably to enable predictable care, to protecting staff, securing data, and reaching environmental goals. The Atellica CI Analyzer makes it possible for both standalone labs and satellite labs of wider health networks to have the same reagents, consumables, and intelligent software as the company's flagship Atellica Solution—now condensed into a 1.9 square meters footprint ideal for smaller laboratories. "Workflow standardization and clinical equivalence are critical components of a successful laboratory operation within a health network. The Atellica CI Analyzer elevates laboratory operations to a new level of agility," said Sharon Bracken, head of Diagnostics for Siemens Healthineers. "Labs today need testing instrumentation and informatics that can easily keep pace with rapidly changing testing demands as they occur. This next-generation laboratory analyzer anticipates workflow bottlenecks, mitigates them proactively, and delivers insights based on data that help laboratory staff do their job more effectively and efficiently." CEO of Acibadem Labmed Clinic Laboratories and a Siemens Healthineers customer, Dr Mustafa Serteser explains, “For mid- or low-volume sized laboratories, the Atellica CI Analyzer is a best-in-class approach. Preservation of space in the lab, staff allocation per analyzer, turnaround time, and cost-effective usage of reagents are important and addressed with this analyzer.” The Atellica CI Analyzer is engineered thoughtfully with differentiating capabilities to leverage downtime and increase lab efficiency and profitability. Random access sampling, micro-volume aspiration, and automatic maintenance and quality control scheduling enable labs to deliver more predictable sample turnaround times. Chemistry and immunoassay engines run independently so throughput is not compromised if one of the two needs to stop. Beyond delivering patient results, labs must address reporting requirements, cybersecurity, and staff satisfaction goals. The Atellica CI Analyzer comes equipped with the Atellica Laboratory Evaluation Suite to deliver inspection-ready reports. This helps labs meet accreditation guidelines without the need for additional software and enables laboratory staff to refocus their time on other critical lab operations. User authentication, role-based authorizations, and audit trails are available for increased security. With a planned menu of more than 200 assays across 20 disease states, each lab in a health network can choose the best tests for its patient population to keep pace with demand and satisfy clinical needs of patients that may otherwise go unmet. More than 50 key assays can deliver results in under 14 minutes.

Long COVID Devastates Patients' Careers and Quality of Life

JULY 14 2023

A survey in Spain of the progress of individuals with long COVID reveals the tremendous toll that the condition has taken on their employment, quality of life, and social support network. The survey revealed that 46% of patients experience slight to significant difficulty performing their work, and that approximately 10% have lost their jobs. Data from the survey, which was conducted between October 2022 and January 2023, were presented at the XXIX National Congress of General and Family Medicine of the Spanish Society for General and Family Physicians. Survey responses were collected from 1122 individuals living in Spain whose symptoms of long COVID persisted during the abovementioned period. Participants already had experienced symptoms for several months. The survey elicited 942 valid responses, and nearly 80% were from women with an average age of 47 years. This profile reflects those of previous surveys conducted by the Spanish Society of General and Family Physicians. Nearly half (46%) of patients with long COVID were on leave at the time or were experiencing significant difficulty as they worked, compared with 15.6% who reported working under normal conditions, according to preliminary results from the follow-up survey. In addition, 9.5% of respondents lost their jobs due the illness, and under 3% had a permanent disability. One goal of the survey was to collect new data to stay up to date on how these patients have progressed from the beginning of the pandemic to now. During the conference, Pilar Rodríguez Ledo, MD, was elected president of the society for the next 4 years. She mentioned that studies like these that involve the progress of patients with long COVID "will provide us with very valuable information" that will help improve the health and the healthcare for these patients. To date, "many people impacted by long COVID continue to experience symptoms and some degree of functional disability that prevents them from resuming life as normal." It is therefore necessary to characterize the condition at the different waves of the pandemic by describing the symptoms and their severity, the age range of those affected, gender-based differences, and functional impact. Regarding quality of life and health status, the results of the survey show that on a scale of 0 to 10, the health of those who have been affected has worsened by an average of 4 points, while the degree of disability has increased by almost 6 points, compared with participants' situation before they got sick. A staggering statistic is that nearly 90% of respondents indicated that they experience worsening on physical (93.3%) and mental (87.8%) exertion.

ResMed Acquires Somnoware

JULY 5 2023

ResMed announced the acquisition of privately held Somnoware, a US leader in sleep and respiratory care diagnostics software. Somnoware software streamlines the processes of physicians as well as sleep and pulmonary function testing labs for diagnosing and evaluating a patient’s sleep and respiratory care test results, ordering PAP treatment equipment, setting up appointments, tracking PAP compliance, and electronically providing this information directly into a patient’s electronic health record – all from within the Somnoware platform. “We are thrilled to welcome the Somnoware team to ResMed,” said ResMed Sleep & Respiratory Care President Lucile Blaise. “We're committed to driving wider adoption of Somnoware's open and interoperable platform to help more people with OSA or COPD get the diagnoses and treatment solutions they need. Improving patients’ experience and health outcomes is our common goal.” “We are very excited about this acquisition,” said ResMed North America General Manager Bill Shoop. “Somnoware’s offering has been well received in the marketplace and it naturally complements our ecosystem of digital solutions across the patient care pathway. Our team is excited to add Somnoware to our portfolio of solutions to help physicians, sleep labs, and HMEs drive greater efficiency and deliver better patient care.” “I’m thrilled to join forces with ResMed and embark on a shared mission of guiding people toward better sleep and improved breathing. Our partnership will open new avenues to help physicians with the critical task of chronic care management,” said Subath Kamalasan, Somnoware cofounder and CEO. “Together, we are committed to driving innovation and delivering solutions that improve the health of patients with sleep disorders and other chronic respiratory diseases.” ResMed intends to retain all Somnoware staff, integrate its offerings into the ResMed brand and solution ecosystem, and maintain the open and device-agnostic nature of Somnoware’s offerings so end users can keep interoperating with various testing solutions and place orders for treatment devices and accessories from any supplier. The transaction’s financial terms are not material to ResMed’s consolidated financial results and were not disclosed. Somnoware engaged Ziegler, a national boutique investment bank, as its financial advisor, and King & Spalding LLP as its legal advisor. DLA Piper served as ResMed’s legal advisor.

Beyond Air Secures up to $40 Million Debt Financing

JUNE 15 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 securing a senior secured debt financing of up to $40 million from funds managed by Avenue Capital Group. The term loan provides Beyond Air with funding to support the ongoing commercial launch of LungFit PH and advance clinical development of the LungFit platform. Avenue Capital Group has agreed to provide the Company with up to $40 million of senior secured term loans funded across three tranches with $17.5 million fully funded at close. The facility has a four-year term from the funding of the first tranche. In addition to certain fees, the Company shall grant the lender warrants to purchase 233,843 shares of common stock. Upon Beyond Air meeting certain milestones, the remaining tranches of $10 million and $12.5 million will be made available, subject to the Company’s discretion, until September 2024 and after April 2024, respectively. “This transaction immediately strengthens our balance sheet and allows us to continue ramping up our commercial efforts for LungFit PH. We are extremely pleased to have a strong partner in Avenue Capital, which has a strong track record in healthcare and a history with nitric oxide,” commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Additionally, this funding allows for the continued development of our clinical pipeline.” Chad Norman, Senior Portfolio Manager at Avenue Capital Group, added, “We are impressed with Beyond Air’s technology and its potential to improve the lives of patients who are in need of inhaled nitric oxide. We believe the Company’s convenient, tankless solution is positioned to be a game changer for those living with chronic conditions.”

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

JUNE 15 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 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.

Two New Devices Unveiled

JUNE 14 2023

The Hans Rudolph, inc. SmartLab Instrumentation System with Insight Software is a flexible system for measurement and analysis of respiratory signals in research applications. The base module can accept up to four sensor modules for measuring flow from pneumotachs and airway or other pressures or a voltage input from an external device. Optional inputs include an oximeter, CO2 sensor, temperature and humidity and digital I/O. The PC software provides real time graphs and calculations of many common respiratory parameters. Data can be saved for analysis or replayed. Custom software modules can be developed for special applications. Also new is the Hans Rudolph, inc. SmartLab Instrumentation System with Insight Software is a flexible system for measurement and analysis of respiratory signals in research applications. The base module can accept up to four sensor modules for measuring flow and pressures. Optional inputs include an oximeter, CO2 sensor, temperature and humidity and digital I/O.

CAIRE Expands Customer Service Support Network

JUNE 14 2023

CAIRE has announced the further expansion of its company’s Authorized Service Center network with the addition of Quality Biomedical, a nationwide provider of fleet management services, and specialists in respiratory equipment maintenance and repair. Through this new agreement, the Boulder, CO-based company will support CAIRE customers with in-warranty and out-of-warranty repairs, which are critical to support the needs of home medical equipment (HME) providers and other major healthcare institutions, including hospitals, skilled nursing facilities, long-term acute care, and other providers across the country. In addition to stationary and portable oxygen concentrators, Quality Biomedical repairs Continuous Positive Airway Pressure (CPAP) and Bilevel Positive Airway Pressure (BiPAP) devices, ventilators, and more. Founded in 2004, Quality Biomedical has grown to a nationwide footprint of eight locations including: its headquarters in Boulder; Allentown, PA; Cartersville, GA; Dallas, TX; Fresno, CA; Fort Wayne, IN; Maryland Heights, MO; and Pinellas Park, FL. “We never forget there is a patient behind every piece of equipment. This is at the core of our values at Quality Biomedical,” said Jim Worrell, Quality Biomedical Chief Commercial Officer. “We leverage our national footprint and advanced technology infrastructure to work more efficiently than the competition and create operational efficiency and reduced costs for our customers. It also helps us achieve a fast turnaround of customer’s equipment so they can focus on what matters — patient care and service.” Quality Biomedical runs 26 trucks serving 45 states with free pick-up and delivery. Customers who wish to ship defective equipment directly to any of the eight Quality Biomedical service centers should contact them directly to discuss the details of this option. “Quality Biomedical’s commitment to excellent service and national footprint will make a meaningful impact on how HMEs and DMEs experience service and access updates throughout the repair process,” said Lanier Hogan, CAIRE Global Technical Service Manager. “Working together, we can offer expanded customer support to providers as they navigate the ever-changing challenges of the healthcare environment.” Quality Biomedical, joins Altra Services Professionals, Oxygen Sales &amp; Service, Inc., ReOx Medical Services, and Repair Authority in supporting 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.

PAP Adherence Lowers ER Visits

JUNE 8 2023

People with heart failure and obstructive sleep apnea (OSA) can significantly reduce hospitalizations and ER visits as well as related costs by being adherent on positive airway pressure (PAP) therapy, according to two studies supported by ResMed and presented at SLEEP 2023. One retrospective study showed people with OSA and systolic heart failure and adherent to PAP had 24% fewer ER visits and incurred 40% lower costs related to hospitalizations and ER visits over 1 year ($3,500 vs. $5,879) compared to non-adherent patients. The study analyzed 1,472 people, exactly half adherent on PAP, half non-adherent. The second retrospective study showed people with OSA and diastolic heart failure and adherent to PAP had 36% fewer ER visits, 57% fewer hospitalizations, and incurred 18% lower related costs (an average $12,732 vs. $15,610) over 1 year. This study analyzed 1,926 people, again exactly half adherent on PAP, half non-adherent. It also found that converting a non-adherent PAP user in this study to an adherent one would save them an average 1.25 visits. The studies hold significant implications for managing heart failure patients, since 76% of them also have sleep apnea. “Since 3 out of 4 people with heart failure also have sleep apnea, these findings underscore the significant role PAP treatment plays in keeping people healthy and out of the hospital,” said Fatima Sert Kuniyoshi, MSc, PhD, lead author and ResMed clinical research director. “I hope this leads to a greater emphasis on PAP prescription and monitoring for the sake of patients as well as the hospitals and ERs that would otherwise require added beds and resources to care for them.” ResMed supported 10 abstracts presented this week at SLEEP 2023, including a global multi-study analysis that estimated over 200 million women worldwide have mild obstructive sleep apnea. That’s equal to 13.4% of women ages 30-70 – or over 1 in 8. The study’s abstract points out that while PAP treatment is beneficial in treating mild OSA, the key to optimizing health outcomes is first diagnosing it – particularly in women: “Females with OSA tend to be milder than their male counterparts, with lower AHIs, less oxygen desaturations, and different symptoms such as fatigue and insomnia. [Therefore], females with mild OSA are at risk of being underdiagnosed and undertreated.” Overall, an estimated 936 million people worldwide have sleep apnea, ranging from mild (5-14 apneic events per hour) to severe (over 30 per hour).

Masimo Announces FDA 510(k) Clearance of Radius VSM

JUNE 5 2023

Masimo announced that Radius VSM, a patient-worn, continuous multi-parameter vital signs monitor, has received FDA 510(k) clearance. Designed on a modular platform, Radius VSM allows clinicians to monitor a wide variety of physiological measurements, including Masimo SET pulse oximetry, noninvasive blood pressure, temperature, respiration rate, and electrocardiography (ECG). By combining the reliability and accuracy of larger bedside monitors with the comfort and freedom of a wearable device, Radius VSM allows ambulation and movement while ensuring patients remain continuously monitored. With its flexibility and expandability, Radius VSM can be easily scaled to match each patient’s unique monitoring needs and level of acuity, across the continuum of care, and to accommodate surges in patient volume. Joe Kiani, Founder and CEO of Masimo, said, “Radius VSM’s unique scalability, versatility, advanced connectivity, and broad range of accurate and automated continuous measurements – all in a wearable device that can be quickly and easily deployed anywhere in the hospital – make it a game-changing tool for clinicians everywhere. Doctors, nurses, and patients in Europe are already experiencing the advantages of Radius VSM and we are excited to share them with US hospitals now too.” As a modular, wearable device, Radius VSM allows providers to equip any hospital bed with comprehensive monitoring, with the ability to quickly add or remove measurement technologies to match each monitoring scenario and offer more personalized care – without additional bedside equipment, network infrastructure, or any tethered connections. Radius VSM can operate as a self-contained device, with high-quality waveform and parameter trend data shown on its built-in multi-touch LED display, with visual and audible alarms and a built-in rechargeable battery. Or, Radius VSM can connect wirelessly to Masimo bedside monitors like Root and to the Masimo Hospital Automation™ platform, simplifying clinical workflows by automating patient data transfer to remote monitoring systems like Masimo Patient SafetyNet™ and electronic medical records (EMRs) – enabling its use as a part of a patient surveillance system and ensuring up-to-date physiological data is available to clinicians throughout the hospital. For example, integrating data from Radius VSM into Patient SafetyNet extends its reach across the hospital for clinicians remotely monitoring patients at centralized viewing stations, viewing continuous monitoring data on their Replica®-equipped smartphones, and benefiting from the workflow automation of the Halo ION patient scoring system – all regardless of where patients are in the hospital, even if they are on the move. Peter Pronovost, MD, PhD, FCCM, Chief Quality and Clinical Transformation Officer at University Hospitals, Ohio, and Clinical Professor of Anesthesiology and Perioperative Medicine at Case Western Reserve School of Medicine, said, “Radius VSM represents another radical transformation of care by Masimo, allowing clinicians to monitor based on patient acuity, not their location. With this new technology, not only can every bed have pulse oximetry monitoring, but if patient acuity increases, we can also easily scale up monitoring, even including ECG, without having to add new hardware or hardwire anything. With the staff shortages in hospitals and the high volume of patients, clinicians need the flexibility to put patients in any bed and ensure that that bed has the capability to monitor each patient appropriately. With Radius VSM, we will have enormous flexibility to manage patient risk across a hospital or, in our case, an entire health system: we can tailor what gets monitored to meet each patient's need, for truly personalized monitoring. And from a safety perspective, by allowing us to monitor patients based on their individual acuity and needs, linked to clinical protocols, we can significantly drive down the risk of possible harm in the hospital.” Joan Carles Rueda, Deputy Director of Medical Technology at FGS Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, where Radius VSM is already in use, said, “Radius VSM is a reliable solution that combines the advantages of a comprehensive monitoring platform with the autonomy of telemetry, giving the patient the safety and freedom to make their hospital stay more humanized. From a technical perspective, we had no doubt about the reliability of the solution as we have been working with Masimo for many years now. They provided the resources to ensure the proper operation of the technology, even evaluating our wireless network, and it has been working smoothly since the installation. We see the device design as an easy to maintain technology as it all is modular and plug and play.” Thomas Callahan, MD, Principal Investigator and Director of the Inpatient Hospital Service for Cardiac Electrophysiology and Pacing, Cleveland Clinic, commented, “We are excited to have gained early experience with this next generation inpatient monitoring system at our center as part of the investigational study. What helps differentiate this technology from existing systems is high fidelity continuous ECG monitoring in a compact modular configuration and integration with high precision optical, electrical, and acoustic sensors for blood pressure, respiratory rate, pulse oximetry, and motion.”

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

FEBRUARY 2 2023

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

FEBRUARY 1 2023

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

FEBRUARY 1 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.

 

 

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