RT NEWS

OxiWear Receives FDA Clearance as a Medical Device

NOV 11 2024

OxiWear, a pioneering company in wearable health technology, is proud to announce that it has received clearance from the U.S. Food and Drug Administration (FDA) for its cutting-edge oxygen data collection device. This certification marks a significant milestone in OxiWear's mission to revolutionize patient care and enhance the quality of life for individuals with chronic diseases. OxiWear is a cutting-edge ear pulse oximeter designed for continuous, real-time measurement of blood oxygen saturation (SpO2) and pulse rate. This device provides unmatched accuracy and convenience while still and during motion, across all skin types, within clinical and home environments. Unlike traditional methods, OxiWear ensures that patients and healthcare providers have constant access to important oxygen saturation data. The continuous data collection capability is vital for the early detection of low oxygen levels, offering prompt haptic and emergency messaging alerts that can potentially save lives. "We are thrilled to receive FDA clearance for our OxiWear device," said Shavini Fernando, CEO of OxiWear. "This validation from the FDA underscores the rigorous testing and development that our team has undertaken to ensure the highest standards of safety and efficacy. Our goal is to provide a reliable, user-friendly solution that empowers patients and supports healthcare professionals in delivering optimal care." OxiWear's device is designed with patient comfort and ease of use in mind. The lightweight, non-invasive wearable can be seamlessly integrated into daily life, providing continuous data collection without disrupting activities. It features advanced sensor technology and wireless connectivity, enabling data to be easily transmitted to healthcare providers for ongoing assessment and management. Dr Panagis Galiatsatos, MD, MHS, Associate Professor of Medicine in the Division of Pulmonary & Critical Care Medicine at Johns Hopkins University Hospital, stated, "This device will save lives; both in the sense of picking up low oxygen levels, and ensuring the quality of life that so many patients lose when they need to measure their oxygen level is preserved. For me, as a physician, recommending OxiWear will be a game changer for my patients, and watching them enjoy life as they measure their oxygen levels confidently and responsibly, reaffirms my passion in medicine and doctoring." The FDA clearance paves the way for OxiWear to expand its market share for its innovative technology. The company is committed to continuing its research and development efforts to expand the capabilities of its platform and address a broader range of health monitoring needs.

Vanderbilt University Medical Center Integrates Masimo Radius VSM

OCT 30 2024

Masimo announced that Vanderbilt University Medical Center (VUMC), a renowned healthcare facility in Nashville, Tennessee, is piloting the use of the Masimo Radius VSM patient-worn vital signs monitor with Masimo Patient SafetyNet supplemental remote monitoring in the Emergency Department (ED) and nontraditional care spaces. Launched as part of a successful pilot program aimed at tackling the ongoing crisis of emergency room congestion, Radius VSM has been used on hallway beds, in the emergency medical service offload area, and on patients in the waiting room who are typically only monitored periodically – thus providing continuous, wireless monitoring for those who may otherwise be left vulnerable to unexpected deterioration. Radius VSM combines the reliability and accuracy of a bedside monitor with the comfort and freedom of a wearable device. With its implementation alongside Patient SafetyNet, clinicians at VUMC are able to remotely monitor vital signs in real time from centralized view stations, simplifying patient data management, enabling quicker intervention during possible deterioration, and enhancing patient safety—even while a patient is up and moving. The modular, scalable monitoring platform offers a range of physiological measurements, including Masimo SET pulse oximetry, measure-on-inflation noninvasive blood pressure, continuous temperature, respiration rate, and 3-leadwire electrocardiography (ECG). By monitoring ED patients with Radius VSM, VUMC is transforming spaces that were traditionally devoid of continuous monitoring into areas of proactive patient care. This level of visibility may help clinicians reduce the use of telemetry, potentially saving time and resources and improving patient throughput and prioritization to other parts of the hospital, such as the general ward or medical and surgical wards. Additionally, Radius VSM’s innovative approach not only enhances the patient and clinician experience but exemplifies how cutting-edge technology can be seamlessly integrated into high-pressure settings like the ED to help streamline continuity of care. The initial success of VUMC’s pilot program is paving the way for an expanded rollout within the ED designed to elevate care for vulnerable patients. Moreover, the promising results may lead to adoption in other areas of the hospital, such as medical and surgical wards, broadening the impact of Masimo’s innovative technology on patient care throughout VUMC. The program also underscores both Masimo’s and VUMC’s commitment to leveraging technology to rethink and improve patient care pathways, setting a new standard for how hospitals manage patient surges in the ED and beyond. “Rising patient acuity and volume at VUMC necessitate strategic initiatives to augment our care infrastructure,” said Neal Patel, MD, MPH, Professor of Clinical Pediatrics and Chief Informatics Officer for HealthIT at VUMC. “Wireless physiologic monitoring in the ED enhances surveillance and vigilance of each patient’s status even when they are in the waiting room.” Bilal Muhsin, Chief Operating Officer of Masimo, said, “We are excited to partner with Vanderbilt University Medical Center to bring Radius VSM to vulnerable patients in the emergency department, where continuous monitoring is not the norm. A core tenet of our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications—and one of the ways we achieve that is through continued innovation. With Radius VSM, clinicians have the power of cutting-edge technology in a modular, scalable design that’s both easy to use and comfortable for the patient. The applications are virtually limitless, and I cannot wait to see how the use of this technology is expanded to enhance patient safety not only in the emergency department, but across the continuum of care.”

MGC Diagnostics Corporation Receives 510K Substantial Equivalence Determination for Ascent Cardiorespiratory Diagnostic Software

OCT 30 2024

MGC Diagnostics Corporation, a global medical technology company dedicated to cardiorespiratory diagnostic solutions, is pleased to announce that it has received notification of 510K Substantial Equivalence Determination from the US Food and Drug Administration (FDA) for its Ascent cardiorespiratory diagnostic software. Ascent is now available for both Pulmonary Function Testing (PFT) and Cardiopulmonary Exercise Testing (CPET). Ascent is a comprehensive software platform designed to streamline cardiorespiratory diagnostic testing and interpretation workflow. The software seamlessly integrates with MGC Diagnostic systems, providing real-time data capture and analysis. Ascent offers a wide range of advanced features, including: Intuitive user interface: The software features a modern and intuitive interface that is easy to learn, use, and customize. Comprehensive reporting: Ascent generates comprehensive reports that can be tailored to meet the specific needs of each organization. Advanced analysis tools: The software includes a variety of advanced analysis tools, such as the ATS/ ERS grading scorecards, automated PFT and CPET interpretation, and exercise prescription. “We are thrilled to receive the notification of substantial equivalence determination for Ascent,” said Todd M. Austin, President at MGC Diagnostics Corporation. “This software platform was designed from the ground up and represents a significant advancement in cardiorespiratory diagnostics. Offering a single, integrated solution for both PFT and CPET enables MGCD to provide our customers with a modern and more efficient way to assess patient respiratory and cardiovascular function.”

Older Patients With COPD at Increased Risk for PE-Associated Death

OCT 30 2024

Patients with chronic obstructive pulmonary disease (COPD) are at an increased risk for fatal pulmonary embolism (PE) and may require personalized, targeted thromboprophylaxis. Those are the conclusions of investigators who analyzed public health data and found that patients with COPD have a markedly increased risk for PE-related death, particularly among those aged 65-85 years. The data suggest that “maybe we should start thinking about if we are admitting a patient with COPD in that specific age group, higher thromboprophylaxis for PE,” said Marwa Oudah, MD, a pulmonary hypertension fellow at the University of Pennsylvania in Philadelphia. She presented her group’s findings in a rapid-fire oral abstract session at the American College of Chest Physicians (CHEST) 2024 Annual Meeting. COPD is a known risk factor for PE. To estimate how the obstructive lung disease may contribute to PE-related deaths among patients of varying ages, Oudah and colleagues drew data on deaths due to an underlying cause of PE from 1999 through 2020 from the Centers for Disease Control and Prevention’s WONDER database. They stratified the patients into two groups — those with or without COPD — whose data were included in the Multiple Causes of Death dataset, according to age groups ranging from 35 years to over 100 years. The investigators calculated proportional mortality ratios in the non-COPD group and applied these to the COPD-positive group among different age ranges to estimate the observed vs expected number of deaths. A total of 10,434 persons who died from PE and had COPD listed among causes of death were identified. The sample was evenly divided by sex. The peak range of deaths was among those aged 75-84 years. The authors saw an increase in PE-related mortality among patients with COPD aged 65-85 years (P < .001). The ratios of observed-to-expected deaths among patients in this age range were “substantially greater than 1” Oudah said, with patients aged 75-79 years at highest risk for PE-related death, with an observed-to-expected ratio of 1.443. In contrast, the rate of observed deaths among patients aged 85-89 years was similar to the expected rate, suggesting that the COPD-PE interaction may wane among older patients, she said. Among patients aged 35-64 years, the risk for death from PE was not significantly higher for any of the 5-year age categories. The investigators emphasized that “given the observed trend, individualized patient assessments are imperative to optimize preventable measures against PE in the aging COPD population.”

New Product Launched

OCT 28 2024

A company has announced the upcoming availability of the Platinum 10L from React Health, a product backed by a long-standing reputation for quality and performance. The Platinum 10L offers a range of key features designed to meet the needs of both patients and healthcare providers: Built to deliver consistent performance, ensuring peace of mind for both clinicians and patients. Enables patients with prescriptions greater than 3 LPM to maintain mobility with ambulatory oxygen, allowing them to stay active even as their condition progresses—without the need to transition to a different device. Features an intuitive control panel for easy operation, a built-in humidifier bottle holder, and simple filter access for convenient maintenance. Operates with lower heat generation and reduced power consumption compared to other high-flow concentrators, offering enhanced comfort and energy savings. As the newest addition to our comprehensive product portfolio, the Platinum 10L enhances our existing oxygen solutions, joining the React Health HomeFill Oxygen System—which promotes greater patient ambulation—and the Stratus 5L Concentrator. React Health is committed to delivering products that prioritize patient comfort and enhance experience.

Vitalograph acquires Morgan Scientific to meet growing global demand for respiratory diagnostic solutions

OCT 23 2024

Vitalograph has announced the acquisition of Massachusetts-based Morgan Scientific, a long-term partner of the respiratory diagnostics leader, strengthening its U.S. commercial footprint and enabling it to meet the growing global demand for its innovative solutions, particularly in advanced pulmonary function testing solutions. Speaking of the acquisition, Frank Keane, CEO of Vitalograph said: “We have a long and successful relationship with Morgan Scientific. This agreement is the natural progression for both companies as our combined expertise allows us to focus on delivering the best possible diagnostic solutions that can enable a better understanding of lung health.” Morgan Scientific is an expert in customer-facing software for advanced PFT systems. ComPAS2, the company’s flagship software powers Vitalograph’s innovative range of advanced PFT solutions, the VitaloPFT Series. Morgan Scientific is also a key distributor for Vitalograph’s pulmonary function testing solutions in the US. Speaking of their collaboration to date, Mr Keane said: “The recent creation of the VitaloPFT Series has given us valuable experience in working as a team and built mutual respect for our individual expertise. Morgan Scientific is a natural complement to the Vitalograph brand, and this development brings incredible value to our customers all over the world. This acquisition paves the way for us to develop our comprehensive PFT range further.” He continued: “Vitalograph is a family-owned company and recognises the pioneering drive of the Morgan family to create a business founded on people, integrity, quality, and innovation. These values are at the heart of Vitalograph and are instilled in every part of our business today.” Gareth Morgan, son of the founder of Morgan Scientific said: “There is no other company in the world that we trust to uphold our legacy of innovation and to continue to put the needs of customers at the forefront of every decision. Joining a globally present and renowned brand such as Vitalograph will enable us to concentrate our efforts on building the business through what we know best - excellence in innovation and customer service.” The acquisition of Morgan Scientific is a key milestone in Vitalograph’s plan to develop its respiratory diagnostics business globally, furthering its goal of providing comprehensive testing solutions that enable the best possible respiratory healthcare. The company is in the middle of an ambitious growth strategy and is on track to treble its respiratory diagnostics business in the four years leading to 2026. The acquisition coincides with Vitalograph’s 50th anniversary of operating and growing in Ennis, Ireland.

US Med-Equip, Sentec Team Up to Support Clinicians Nationwide

OCT 18 2024

As hospitals across the United States navigate the challenges of delivering patient care in increasingly high-acuity environments, a new partnership between US Med-Equip (USME), a leading provider of medical equipment rentals and services, and Sentec, a global leader in respiratory monitoring technology, is set to help more clinicians with real-time insights into the conditions of critically ill respiratory patients, including newborns in Neonatal Intensive Care Units (NICUs). Under the new partnership, USME added Sentec's transcutaneous monitoring (TCM) devices as part of its extensive portfolio of life-saving medical equipment. Sentec’s TCM devices provide continuous, non-invasive monitoring of a patient's carbon dioxide levels and oxygen saturation to help clinicians make better-informed decisions in real-time —  particularly vital in the care of patients, such as those in the NICU, where precise monitoring of respiratory function is crucial. In addition to transcutaneous monitoring, Sentec's Intrapulmonary Percussive Ventilation (IPV) technology will also be available through this partnership. IPV therapy supports the front-line care of critically ill respiratory patients as a management tool to restore lung function and mobilize secretions. By adding both TCM and IPV technology into USME's rental and service offerings, healthcare providers gain greater access to non-invasive equipment often preferred by clinicians, especially in intensive care units, emergency departments, and during transport of critically ill patients. "Partnering with US Med-Equip enables us to better support our shared hospital customers dedicated to providing the highest quality care for respiratory-compromised patients, especially during periods of high patient census and urgent capital needs,” Sentec CEO Bob Cormier said. This partnership reflects a growing trend in healthcare, where the integration of advanced technology with on-demand service is increasingly essential. Under the new partnership, US Med-Equip, known for its rapid response and high-quality service, is offering Sentec’s devices with the level of support that has made them a trusted partner for hospitals nationwide. "Sentec shares our unwavering commitment to supporting clinicians in delivering exceptional patient care," Greg Salario, CEO of USME, said. "This collaboration enhances our ability to provide healthcare partners with access to the most advanced patient monitoring solutions, precisely when they need them most."

Patients Faced Long-Term Fatigue After COVID-19

OCT 16 2024

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was linked to an overall 3% increase in self-reported fatigue and a twofold increase in malaise after minimal exertion up to 18 months after infection. Hospitalized patients experienced a 23% increase in fatigue scores. Researchers conducted a cohort study between 2021 and 2023 involving 50,115 Danish residents aged 15 years or older, half of whom had tested positive for COVID-19. Participants answered questions on their current and previous 6 months of fatigue and other symptoms based on a scale and at least one follow-up questionnaire between 2 and 18 months after testing. Participants were excluded if they reported SARS-CoV-2 infection between the index test date and the last follow-up questionnaire. Roughly half of each group (positive or negative for SARS-CoV-2) were between the ages of 50 and 69 years. Test-positive participants had two times higher odds of experiencing malaise following minimal exertion (odds ratio [OR], 2.04; 95% CI, 1.81-2.30) than those who had tested negative. People who had been hospitalized with acute SARS-CoV-2 had a 23% increase in their fatigue (score ratio, 1.23; 95% CI, 1.20-1.26) compared with people who tested negative 2-18 months after testing. Test-positive participants had almost twice the odds (OR, 1.93; 95% CI, 1.64-2.26) of severe fatigue. People with preexisting psychiatric conditions were not at a significantly higher risk for fatigue following infection. "The burden of post-COVID-19 condition fatigue was highest among patients with more severe cases of infection and was long-lasting, suggesting that patients with severe acute infection may benefit from clinical follow-up for fatigue," study authors wrote.

Artificial Intelligence Helps Diagnose Lung Disease in Infants and Performs Better Than Trainee Doctors

OCT 16 2024

Artificial Intelligence (AI) can assist doctors in assessing and diagnosing respiratory illnesses in infants and children, according to two new studies presented at the European Respiratory Society (ERS) 2024 Congress. Researchers can train artificial neural networks (ANNs) to detect lung disease in premature babies by analyzing their breathing patterns while they sleep. “Our noninvasive test is less distressing for the baby and their parents, meaning they can access treatment more quickly, and may also be relevant for their long-term prognosis,” said Edgar Delgado-Eckert, PhD, adjunct professor in the Department of Biomedical Engineering at The University of Basel, Switzerland, and a research group leader at the University Children’s Hospital, Switzerland. Manjith Narayanan, MD, a consultant in pediatric pulmonology at the Royal Hospital for Children and Young People, Edinburgh, and honorary senior clinical lecturer at The University of Edinburgh, United Kingdom, said chatbots such as ChatGPT, Bard, and Bing can perform as well as or better than trainee doctors when assessing children with respiratory issues. He said chatbots could triage patients more quickly and ease pressure on health services. Researchers at The University of Edinburgh provided 10 trainee doctors with less than 4 months of clinical experience in pediatrics with clinical scenarios that covered topics such as cystic fibrosis, asthma, sleep-disordered breathing, breathlessness, chest infections, or no obvious diagnosis. The trainee doctors had 1 hour to use the internet, although they were not allowed to use chatbots to solve each scenario with a descriptive answer. Each scenario was also presented to the three large language models (LLMs): OpenAI’s ChatGPT, Google’s Bard, and Microsoft’s Bing. Six pediatric respiratory experts assessed all responses, scoring correctness, comprehensiveness, usefulness, plausibility, and coherence on a scale of 0-9. They were also asked to say whether they thought a human or a chatbot generated each response. ChatGPT scored an average of 7 out of 9 overall and was believed to be more human-like than responses from the other chatbots. Bard scored an average of 6 out of 9 and was more “coherent” than trainee doctors, but in other respects, it was no better or worse than trainee doctors. Bing and trainee doctors scored an average of 4 out of 9. The six pediatricians reliably identified Bing and Bard’s responses as nonhuman. “Our study is the first, to our knowledge, to test LLMs against trainee doctors in situations that reflect real-life clinical practice,” Narayanan said. “We did this by allowing the trainee doctors to have full access to resources available on the internet, as they would in real life. This moves the focus away from testing memory, where LLMs have a clear advantage.”

New Collection Aims to Improve Sleep Health

SEP 30 2024

ResMed, the world’s leading health technology company focused on sleep, breathing, and care delivered in the home, today announced new patient-centric products designed to enhance the therapy journey for sleep apnea patients. These innovations integrate with digital wearable devices and generative artificial intelligence designed to deliver a more personalized sleep health experience and improve overall health. ResMed’s 2024 Global Sleep Survey found that 44% of Americans get fewer than three good nights of sleep each week, significantly impacting their quality of life. With the rising popularity of digital wearables like smartwatches and health trackers, individuals now have access to data-driven insights that empower them to be active participants in improving their health. Sleep health has become a key focus in this evolving landscape, with more than half (54%) of respondents from a recent ResMed survey expressing interest in purchasing a wearable device with sleep-tracking capabilities. Digital wearables give consumers instant access to sleep and other critical health insights, giving them valuable information to collaborate with their healthcare providers. ResMed’s latest innovations are designed with users at the forefront, offering personalized insights into sleep patterns and the flexibility to help people stay on track with sleep therapy, no matter where life takes them. ResMed myAir is an intuitive app that empowers patients to stay engaged with their CPAP therapy, leading to better health outcomes. Through interactive coaching and the ability to track nightly sleep data, myAir has been associated with significantly increased CPAP usage, with 87% of patients achieving therapy compliance. New myAir Patient Engagement Features Include: myAir smartwatch app: Now available on Apple and Android smartwatches, this app allows users to monitor their therapy data at a glance, making it easier to stay engaged with CPAP therapy; sleep staging: Integrates sleep stages data (awake, REM, core, and deep) from Apple Health and Health Connect into myAir, giving users a clearer understanding of their entire sleep cycle. personalized coaching: Offers customized tips and strategies based on behavior science and machine learning to help users stay on track with CPAP therapy through personalized support; holistic trends: Provides a comprehensive view of a user’s health by providing data such as tracked steps, energy burned, weight, blood oxygen, body mass index, daily exercise, heart rate variability, resting heart rate, time in bed, and total time asleep, from Apple Health and Health Connect along with CPAP therapy data, all in one place. “We know that digital wearables and other innovative technologies like AI can help consumers better understand their sleep habits and create a personalized pathway to better rest,” said Carlos M. Nunez, M.D., Chief Medical Officer at ResMed. “Regular sleep tracking can offer crucial insights that empower people to make informed decisions about improving their sleep quality both now and in the future.” ResMed’s new AI-enabled health concierge, Dawn, is changing how people learn about sleep apnea. Dawn provides instant, 24/7 access to many answers about sleep health, ResMed products, and CPAP therapy support. Using Generative AI, Dawn offers personalized guidance and connects users with the information they need in real time.

Beyond Air Provides LungFit PH System to hospital

SEP 27 2024

Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, is proud to announce the deployment of its groundbreaking LungFit PH system to the US Naval Hospital Guam. This partnership, made possible through collaboration with TrillaMed, marks a significant advancement in the neonatal critical care unit, offering enhanced care for newborns in need of respiratory support. The LungFit PH system is an innovative device designed to generate Nitric Oxide (NO) from room air and deliver NO for the treatment of persistent pulmonary hypertension in neonates (PPHN), a condition that affects the lungs and heart of newborns. The system provides a safe, efficient, and user-friendly solution to address critical respiratory conditions, ensuring that the hospital’s youngest and most vulnerable patients receive the highest standard of care. Key Features of the LungFit PH System: Portable and compact design, making it ideal for intensive care settings; advanced nitric oxide generating technology with no need for high-pressure cylinders; rapid response for improved oxygenation in neonates with PPHN; easy integration into existing hospital infrastructure. “We are honored to support the US Naval Hospital Guam in their mission to provide top-tier neonatal care,” said Steve Lisi, CEO of Beyond Air. “Through our partnership with TrillaMed, we are able to extend the reach of our LungFit PH, delivering critical solutions to the healthcare community. This collaboration is a testament to our commitment to advancing neonatal care and improving patient outcomes.” The US Naval Hospital Guam serves as a critical care provider for the military community in the region. More than 17,000 active-duty military personnel and family members currently are stationed on Guam, which is expected to increase by 2,500 in the next two years. The US Naval Hospital Guam delivers an average of 315 babies per year, with that number expected to rise to 487 births by 2033. The introduction of the LungFit PH system underscores the hospital’s dedication to utilizing state-of-the-art technologies in neonatal care, ensuring military families have access to the latest in respiratory treatment options.

New Face Mask Unveiled

SEP 17 2024

React Health is thrilled to announce the latest addition to our Rio II family of masks, The Rio II Full Face Mask is designed to enhance patient comfort and compliance to sleep therapy, the Rio II offers a cost competitive alternative to many leading masks on the market without compromising quality. The Rio II series now includes both the Rio II Nasal Pillows and the Rio II Full Face Mask, offering versatile options to meet your specific needs. Our Rio II Full Face Mask provides a compelling alternative to products like the ResMed AirFit F30, Philips Amara View, and Fisher & Paykel Evora. With its magnet-free, minimal contact design, it promises unparalleled comfort and performance. Key Features and Benefits: Under the Nose Cushion: Allows for a full range of vision, enables wearing glasses, and helps minimize nose discomfort. Comfort, Fit, and Seal: Ensures stability and ease of use throughout the night. Adjustability and Breathability: Tailored to comfort preferences with a low noise level, adjustable headgear and durable materials. Cost-Effective Alternative: Offering quality and affordability, the Rio II masks are a reliable choice for effective sleep therapy. Positioned as the newest addition to our comprehensive product portfolio, the Rio II Full Face integrates seamlessly with our existing solutions, including the React Health Connect Compliance platform with EnsoData AI integration, a full line of FDA-cleared PAP devices (APAP/CPAP and Bilevel), and home sleep testing solutions through React Dx, to provide a holistic approach to sleep therapy. React Health is committed to delivering products that prioritize patient comfort and enhance the sleep therapy experience. We welcome the opportunity to discuss how the Rio II family of masks can meet your specific business needs and improve your overall satisfaction with our solutions.

For Which Adults Are RSV Vaccination Programs Cost-Effective?

SEP 13 2024

Vaccines for respiratory syncytial virus (RSV) can reduce hospitalization and costs for older adults, and vaccination programs focused on patients with underlying medical conditions appear to be the most cost-effective, according to a new study in Canada. For instance, vaccinating patients aged ≥ 70 years who have one or more chronic medical conditions was the best strategy for a cost-effectiveness threshold of $50,000 CAD per quality-adjusted life year (QALY), the authors wrote. "RSV is a common respiratory virus that can cause serious respiratory illness in older adults, resulting in hospitalization, admission to the intensive care unit, and death. The risk for severe RSV illness increases with age and with certain medical conditions," lead author Ashleigh Tuite, PhD, manager of health economics and modeling at the Centre for Immunization Surveillance and Programs at the Public Health Agency of Canada, said. “We now have authorized vaccines for RSV in Canada that have the potential to prevent disease and reduce healthcare and related costs," she added. "Understanding the costs, benefits, and cost-effectiveness of potential RSV vaccination strategies can help with the development of vaccine program recommendations." The investigators conducted a model-based cost-utility analysis of RSV vaccination programs across various age ranges and medical risks, looking at a combination of age-only, medical-risk-only, and age-plus-medical-risk-based strategies. They modeled medically attended RSV disease requiring either outpatient care (with a healthcare provider or emergency department visit) or inpatient care (through hospital admission, with or without intensive care unit admission). Previous cost-effectiveness studies have focused on patients aged ≥ 60 or 65 years. Tuite and colleagues included patients aged ≥ 50 years, following a hypothetical population of 100,000 people over a 3-year period with three full RSV seasons and peak activity between January and March. In the model, vaccine characteristics were based on the two RSV vaccines authorized for patients aged ≥ 60 years in Canada as of May 2024. The researchers assumed protection of 2-3 years in different scenarios. They calculated sequential incremental cost-effectiveness ratios (ICERs) in 2023 Canadian dollars per QALY from the healthcare system and societal perspectives, using a discount rate of 1.5% for costs and outcomes. Without vaccination, the model estimated 120,000-144,000 RSV cases that required medical attention, 10,000-14,000 hospital admissions, and 1015 deaths annually among patients aged ≥ 60 years in Canada.

Blood Eosinophil Counts Might be Predictor for Childhood Asthma

SEP 13 2024

Simply relying on clinical symptoms is insufficient to predict which children with wheezing will develop asthma and respond to treatments. More objective tests like blood eosinophil counts are needed for early diagnosis and to avoid unnecessary medication use in children unlikely to develop asthma. Sejal Saglani, MD, PhD, a professor of pediatric respiratory medicine at National Heart and Lung Institute, Imperial College, London, England, said that preschool wheezing has long-term adverse consequences through to adulthood. "We need to prevent that downward trajectory of low lung function," she said, presenting the latest research in the field at the European Respiratory Society (ERS) 2024 International Congress. Wheezing affects up to one third of all infants and preschool children, with one third developing asthma later in life. "It's important to identify those kids because then we can treat them with the right medication," Mariëlle W.H. Pijnenburg, MD, PhD, a pulmonary specialist at Erasmus University Rotterdam in Rotterdam, the Netherlands, said. "We cannot just use clinical phenotype to decide what treatment a child should get. We need to run tests to identify the endotype of preschool wheeze and intervene appropriately," Saglani added. In a cluster analysis, Saglani and her colleagues classified preschool children with wheezing into two main subgroups: Those who experience frequent exacerbations and those who experience sporadic attacks. Frequent exacerbators were more likely to develop asthma, use asthma medications, and show signs of reduced lung function and airway inflammation, such as higher fractional exhaled nitric oxide and allergic sensitization. "Severe and frequent exacerbators are the kids that get in trouble," she said. "They're the ones we must identify at preschool age and really try to minimize their exacerbations."

Majority of Hospitalized Patients With COPD Misuse Inhalers

SEP 13 2024

Approximately two thirds of hospitalized adults with chronic obstructive pulmonary disease (COPD) received suboptimal treatment with inhalers, mainly resulting from errors, based on data from 96 individuals. "Numerous studies have highlighted the significant issue of improper inhaler use in outpatient settings, but the extent of this problem within hospital settings remains poorly documented," said lead author Gaël Grandmaison, MD, of the University of Fribourg, Fribourg, Switzerland, in an interview. "This gap in knowledge is concerning, especially considering that several factors associated with suboptimal inhaler use, such as improper inhalation techniques, insufficient inspiratory flow, or the use of inhalers that are not suited to the patient's specific characteristics, are associated with poorer disease control, more frequent exacerbations, and increased costs," Grandmaison said. To better characterize the prevalence of and factors associated with inhaler misuse in hospitalized patients with COPD, the researchers reviewed data from consecutive patients with COPD who were hospitalized in the general internal medicine department of a single institution between August 2022 and April 2023. Patients were assessed for peak inspiratory flow (PIF) and inhaler technique. The primary outcome was the proportion of misused inhalers, which was defined as any inhaler used with either insufficient PIF and/or a critical error. The mean age of the patients was 71.6 years, 63% were men, and 67% were hospitalized for COPD exacerbations. Patients used 3.0 inhalers on average. The study included 96 patients and 160 inhalers that were assessed at hospital admission. Overall, 111 were misused. Of those misused, 105 were associated with a critical error in the inhalation technique, and 22 were used with an insufficient PIF. After an episode of misuse, patients received targeted teaching on correct use that was repeated until they performed the technique without errors. The percentage of inhaler misuse decreased over the course of the teaching sessions. The proportion of inhaler misuse decreased to 20.6%, 9.4%, and 5.6% after one, two, and three sessions, respectively.

Company Reaches Zenith

SEP 10 2024

React Health is proud to announce that we have been selected as a recipient of the 2024 AARC Zenith Award, an honor given by the American Association for Respiratory Care (AARC). Out of more than 300 companies, React Health was chosen as one of only five organizations to receive this distinguished award, recognized for our outstanding contributions to the respiratory care profession. This prestigious award reflects our commitment to excellence in delivering quality equipment and services to healthcare professionals and their patients. AARC members recognized React Health’s dedication across several key criteria, including: 1. Quality of equipment and supplies; 2. Accessibility and helpfulness of sales personnel; 3. Responsiveness to customers; 4. Service record; 5. Truth in advertising; 6. Support of the respiratory care profession. The AARC Zenith Award is one of the highest honors in the respiratory care industry, and it highlights the trust and confidence that respiratory therapists and healthcare providers place in our company. This recognition serves as a testament to the hard work and dedication of the entire React Health team. "We are extremely honored to receive the 2024 AARC Zenith Award," said Bill Shoop, CEO of React Health. "This award reflects our unwavering commitment to providing high-quality products and services that empower healthcare professionals and improve patient outcomes. We are grateful to the respiratory care community for this incredible recognition and remain dedicated to advancing respiratory care through innovation, collaboration, and excellence." The award was to be formally presented at the AARC International Respiratory Congress in November, held in Orlando, Florida. React Health would like to express its gratitude to the AARC and its members for their continued support. We look forward to maintaining the highest standards of service and innovation in the respiratory care field. For more information about React Health and our product offerings, please visit www.reacthealth.com.

New Tracheostomy Filters

SEP 10 2024

Passy-Muir, Inc., Irvine, California, announced the release of a new filter designed for tracheostomy patients. Responding to the need for an effective, lightweight filter for patients with tracheostomy, the new Passy Muir Tracheostomy Viral and Bacterial Airway Protection Filter (PM-APF15) attaches easily to the 15mm hub of a tracheostomy tube and safely and effectively filters out viral, bacterial, and other particulate matter. The new lightweight, non-sterile filter is designed for single-patient use for non-mechanically ventilated pediatric and adult tracheostomy patients, and provides bacterial and viral filtration efficiency of 99.9%, while effectively filtering out 99% of all airborne particulates. For use in clinical settings, including hospitals, sub-acute, rehabilitation, outpatient, skilled nursing, and long-term care, as well as in the home setting. For adults with Tidal Volumes 300ml and pediatrics with Tidal Volumes 80 ml. Not for use on neonate or infant patients. The PM-APF15 filter comes with detailed instructions for use, and is manufactured in the United States.

Hospital Implements Telemonitoring to Facilitate Early Discharge of Premature Newborns

SEP 10 2024

Masimo announced that Saint-Denis Hospital Center is adopting the use of the Masimo SafetyNet cloud-based telemonitoring platform as part of an experimental mobile neonatology unit aimed at facilitating earlier discharge of premature newborns from the ICU to the home. Launched in February, this pioneering project allows vulnerable neonates to return home safely to their families while remaining under the close supervision of the hospital. Masimo SafetyNet offers a streamlined approach to remote patient management that can be scaled and tailored to each patient’s unique care needs, offering wireless continuous monitoring and spot-check devices, customizable CarePrograms with symptom reporting, and a secure in-hospital clinical portal that allows care teams to keep watch over a large volume of patients. Following discharge, families are sent home with an easy-to-use pulse oximetry sensor, Radius PPG, powered by clinically proven Masimo Signal Extraction Technology (SET), and an intuitive smartphone application. The sensor, worn on the foot of neonatal patients, includes a chip that sends health data to the app, where parents can keep an eye on their baby’s condition and communicate with caregivers. From the hospital, caregivers receive that same data as well as notification logs about changes in a patient’s condition—enabling them to prioritize those who may need care escalation. Staff members at Saint Denis were already familiar with the benefits of home-based care. Dr Pascal Bolot, head of neonatal intensive care at Saint-Denis, first implemented home visits in partnership with the ARS, a regional health authority, to address the lack of care following hospital discharge and alleviate the distress of the abrupt shift from hospital to home for families. Saint-Denis’ experience providing home visits was a key advantage when it came to implementing remote neonatal monitoring, alongside 11 other French facilities taking part in the trial. With the integration of Masimo SafetyNet, the pilot has expanded its approach to be more comprehensive and innovative – an approach that, according to Dr Alizée Lori, the pediatrician at Saint-Denis who oversees the mobile unit, “[brings] premature newborns into a secure home environment equivalent to hospital-grade monitoring quality.” The addition of this technology serves as an opportunity to “put the premature newborn back in the center of the family,” added Dr Bolot. The mobile neonatology unit benefits caregivers and families alike. As a general rule, neonatology services do not allow premature babies to return home before the end of 36 weeks of corrected age. Masimo SafetyNet may help make it possible to secure an earlier return home, serving as a relay between hospital staff and families and providing comprehensive support for premature babies in their first few weeks of life. The success of this program could lead to the deployment of Masimo SafetyNet in other care areas, particularly in pediatric care, including home patient management of various conditions. Dr Lori commented, “We chose this Masimo solution because of its innovative nature and the practical aspect of wireless physiological data monitoring; it’s easy for families to use and gives our medical team easy access to patients’ health data from the hospital. Since Masimo is used in many neonatology departments, including CH Delafontaine, we were confident in the reliability of the data recorded. This solution allows us to adapt care protocols to meet the needs of our vulnerable patients. Additionally, the Masimo team has supported us since the beginning of the project, and is still available on a daily basis.” The Saint-Denis Hospital Center, made up of the Delafontaine and Casanova sites, is the only public healthcare facility in the Plaine Commune area, serving a population of 435,000 people. The facility offers 839 hospital beds with adult, pediatric and gynecological emergency services, a large consultation platform, and a type 3 perinatal center for monitoring high-risk pregnancies through high-quality maternal and neonatal care for mothers and children. Joe Kiani, Founder and CEO of Masimo, said, “Our mission from the beginning has been to improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications. And it’s incredible to see how far we’ve come. To see parents be able to be with their newborn baby and each other is extremely gratifying, and to help the dedicated team at Saint-Denis provide earlier discharge yet keep the same level of monitoring is something we’re all proud of. Masimo has long fought to protect vulnerable newborns through innovative continuous monitoring, and it is truly rewarding to see how Masimo SafetyNet—using the same technology we’ve developed and perfected over 35 years—is helping Saint-Denis extend comprehensive care to neonatal patients at home. As healthcare becomes more predictive, preventative, and personalized than ever before, we are committed to innovating solutions that put patients at the center of the care ecosystem.”

Patients With COPD May Use Mobile Tech for Disease Management

AUG 30 2024

A recent study found a wearable device and mobile app were deemed useful by patients with COPD to aid in the management of their condition, based on data from 26 adults who used devices and apps for 6 months. Self-management interventions for COPD can potentially improve quality of life and reduce hospitalizations, wrote Robert Wu, MD, associate professor in the Department of Medicine at the University of Toronto, Toronto, Ontario, Canada, and colleagues. However, data on the use of devices and apps to manage COPD by providing reminders for self-care, predicting early exacerbations, and facilitating communication with healthcare providers are limited, they said. In a study published in COPD: Journal of Chronic Obstructive Pulmonary Disease, the researchers reported details from interviews with 26 adult patients with COPD who used a wearable device and app for 6 months to help manage their condition. The interviews were part of a larger cohort study. "The motivation for this study was to understand the patient perspective on using wearables to help support their chronic lung condition," Wu said in an interview. "People with COPD can be at high risk of being admitted to hospital, so it is important to see if innovative technology like wearables or remote monitoring can help them," he said. Individuals with COPD tend to be older and less technologically adept, and they may be less willing to adopt new technology, he added. "We wanted to understand what would make people use a self-management app," he said. On enrollment in the study, patients received a smartwatch and a smartphone with a preinstalled app for COPD management. The app included daily reminders to take medication, perform guided breathing sessions, check blood oxygen on the smartwatch or an oximeter, and complete a symptom questionnaire. The app also allowed participants to record when they exercised and provided feedback on heart rate and daily activity, including passive step counts. Participants earned stars for meeting daily exercise goals of active minutes and total steps. Participants received training in the use of the app from members of the research team and completed semi-structured interviews after using the items for 6 months. The researchers divided their findings into four main themes: Information, support and reassurance; barriers to adoption; impact on communication with healthcare providers; and opportunities for improvement. Overall, most patients reported that the feedback they received through the app was useful. In particular, participants reported that the app and smartwatch provided reassurance and feedback about stable vitals during exercise, which encouraged some to adhere to regular exercise routines. Approximately two thirds (65%) said that the daily exercise reminders were motivational. In addition, 20% reported that they interpreted vital data, including heart rate, as a signal to slow down.

COPD Treatment Cost May Put It Out of Reach

AUG 30 2024

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the US Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at an unreasonably high annual cost, authors of a cost-effectiveness analysis say. Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer. In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second (FEV1) within 0-12 hours of administration compared with placebo. In addition, patients were found to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group. But as authors of the analysis from the Boston-based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Vernona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7500 to $12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests. "Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments," said David Rind, MD, chief medical officer of ICER in a statement. In an interview, Rind noted that the high price of ensifentrine may lead payers to restrict access to an otherwise promising new therapy. "Obviously many drugs in the US are overpriced, and this one, too, looks like it is overpriced. That causes ongoing financial toxicity for individual patients and it causes problems for the entire US health system, because when we pay too much for drugs we don't have money for other things. So I'm worried about the fact that this price is too high compared to the benefit it provides," he said. As previously reported, as many as 1 in 6 persons with COPD in the US miss or delay COPD medication doses owing to high drug costs. "I think that the pricing they chose is going to cause lots of barriers to people getting access and that insurance companies will throw up barriers. Primary care physicians like me won't even try to get approval for a drug like this given the hoops we will be made to jump through, and so fewer people will get this drug," Rind said. He pointed out that a lower wholesale acquisition cost could encourage higher volume sales, affording the drug maker a comparable profit to the higher cost but lower volume option.

CPAP Therapy: A Potential Solution for Hypertensive Complications in Pregnancy

AUG 30 2024

Continuous positive airway pressure (CPAP) therapy in pregnant women with obstructive sleep apnea (OSA) was associated with a 35% reduction in the risk for gestational hypertension and a 30% reduction in the risk for preeclampsia. These findings suggest that CPAP treatment may be beneficial in managing hypertensive complications during pregnancy. Researchers conducted a systematic review and meta-analysis of six studies involving 809 pregnant women with OSA to find out whether use of a CPAP machine reduced their risk of developing gestational hypertension and preeclampsia. Data sources included PubMed, Embase, and the Cochrane Database of Systematic Reviews and Clinical Trials, searched from inception to November 5, 2023. Studies from the United States, Thailand, Japan, and Serbia were included. Inclusion criteria were pregnant women with OSA confirmed by polysomnography or home sleep test who were treated with CPAP, and clearly defined experimental and control groups. Random-effects model meta-analyses were performed, and risk ratios (RRs) were reported, with subgroup analysis and meta-regression based on age and body mass index (BMI). CPAP therapy in pregnant women with OSA was associated with a 35% reduction in the risk for gestational hypertension (RR, 0.65; 95% CI, 0.47-0.89; P = .008). CPAP use was linked to a 30% reduction in the risk for preeclampsia (RR, 0.70; 95% CI, 0.50-0.98; P = .04). Meta-regression analysis showed that patients' age and BMI were not correlated with the reduction in risk for hypertension and preeclampsia. The findings suggest that CPAP treatment may reduce the risk for adverse hypertensive outcomes in pregnant women with OSA. "Future research should prioritize assessing treatment adherence and exploring the optimal timing and duration of CPAP use," the study authors wrote.

New Monitoring Software for Portable Oxygen Concentrator Testing

AUG 28 2024

The Monitor Software for the O2 Conserver Checker from Dirks Instruments provides an easy way to test portable oxygen concentrators (POC) and verify that they are performing to the manufacturer’s specifications. The O2 Conserver Checker simulates a patient breathing on an oxygen device and then measures key parameters such as pressure required to trigger an oxygen pulse, volume of oxygen delivered and the oxygen concentration in the pulse. These measured values are then sent to the Monitor Software over a Bluetooth connection and displayed on the software both as text and in graphs. Home care dealers, service centers, pulmonary rehab centers and anyone who needs to make sure their patient’s oxygen system is working properly can use this combination to check the operation of oxygen devices. To make it easy to use, the Monitor Software has built-in test guides for many of the popular portable concentrators. This guide provides suggested test points and indicates with pass / fail graphics if the device being tested meets the manufacturers specifications at each setting tested. The user is guided through a set of tests and when the tests are complete a report can be saved and printed out. New devices can be easily added and the set of tests can also be modified to fit an individual user’s needs. This combination provides a dealer with confidence that the products in inventory are working properly and ready to be used by their customers. Testing devices can save time and money by reducing return trips to a customer to replace a faulty device and it also helps determine when it is time to service or repair a device. Aaron Dirks, President of Dirks Instruments says: “The new Monitor Software makes it simple to test a variety of different devices and know that they are going to work properly. The built-in test specifications remove the guesswork of wondering what the proper test results should be for a device being tested.”

New Family of Masks Revealed

AUG 20 2024

React Health has introduced the latest addition to its Rio II family of masks, The Rio II Full Face Mask. Designed to enhance patient comfort and compliance to sleep therapy, the Rio II Full Face offers a cost competitive alternative to many leading masks on the market without compromising quality. The Rio II series now includes both the Rio II Nasal Pillows and the Rio II Full Face Mask, offering versatile options to meet your specific needs. Our Rio II Full Face Mask provides a compelling alternative to leading products like the ResMed AirFit F30, Philips Amara View, and Fisher & Paykel Evora. With its magnet-free, minimal contact design, it promises unparalleled comfort and performance. Key Features and Benefits: Under the Nose Cushion: Allows for a full range of vision, enables wearing glasses, and helps minimize nose discomfort. Comfort, Fit, and Seal: Ensures stability and ease of use throughout the night. Adjustability and Breathability: Tailored to comfort preferences with a low noise level, adjustable headgear and durable materials. Cost-Effective Alternative: Offering quality and affordability, the Rio II masks are a reliable choice for effective sleep therapy. Positioned as the newest addition to our comprehensive product portfolio, the Rio II Full Face integrates seamlessly with our existing solutions, including the React Health Connect Compliance platform with EnsoData AI integration, a full line of FDA-cleared PAP devices (APAP/CPAP and Bilevel), and home sleep testing solutions through React Dx, to provide a holistic approach to sleep therapy. We are committed to delivering products that prioritize patient comfort and enhance the sleep therapy experience. Reach out to your local React Health representative to see how the Rio II family of masks can meet your specific business needs and improve your overall satisfaction with our solutions.

Patients With COPD May Use Mobile Tech for Disease Management

AUG 15 2024

Could mobile technology help patients with chronic obstructive pulmonary disease (COPD) who may not seek care until they experience an exacerbation? A recent study found a wearable device and mobile app were deemed useful by patients with COPD to aid in the management of their condition, based on data from 26 adults who used devices and apps for 6 months. Self-management interventions for COPD can potentially improve quality of life and reduce hospitalizations, wrote Robert Wu, MD, associate professor in the Department of Medicine at the University of Toronto, Toronto, Ontario, Canada, and colleagues. However, data on the use of devices and apps to manage COPD by providing reminders for self-care, predicting early exacerbations, and facilitating communication with healthcare providers are limited, they said. In a study published in COPD: Journal of Chronic Obstructive Pulmonary Disease, the researchers reported details from interviews with 26 adult patients with COPD who used a wearable device and app for 6 months to help manage their condition. The interviews were part of a larger cohort study. "The motivation for this study was to understand the patient perspective on using wearables to help support their chronic lung condition," Wu said in an interview. "People with COPD can be at high risk of being admitted to hospital, so it is important to see if innovative technology like wearables or remote monitoring can help them," he said. Individuals with COPD tend to be older and less technologically adept, and they may be less willing to adopt new technology, he added. "We wanted to understand what would make people use a self-management app," he said. On enrollment in the study, patients received a smartwatch and a smartphone with a preinstalled app for COPD management. The app included daily reminders to take medication, perform guided breathing sessions, check blood oxygen on the smartwatch or an oximeter, and complete a symptom questionnaire. The app also allowed participants to record when they exercised and provided feedback on heart rate and daily activity, including passive step counts. Participants earned stars for meeting daily exercise goals of active minutes and total steps. Participants received training in the use of the app from members of the research team and completed semi-structured interviews after using the items for 6 months. The researchers divided their findings into four main themes: Information, support and reassurance; barriers to adoption; impact on communication with healthcare providers; and opportunities for improvement. Overall, most patients reported that the feedback they received through the app was useful. In particular, participants reported that the app and smartwatch provided reassurance and feedback about stable vitals during exercise, which encouraged some to adhere to regular exercise routines. Approximately two thirds (65%) said that the daily exercise reminders were motivational. In addition, 20% reported that they interpreted vital data, including heart rate, as a signal to slow down.

COPD Treatment Cost May Put It Out of Reach

AUG 15 2024

Ensifentrine (Ohtuvayre), a novel medication for the treatment of chronic obstructive pulmonary disease (COPD) recently approved by the US Food and Drug Administration, has been shown to reduce COPD exacerbations and may improve the quality of life for patients, but these potential benefits come at an unreasonably high annual cost, authors of a cost-effectiveness analysis say. Ensifentrine is a first-in-class selective dual inhibitor of both phosphodiesterase 3 (PDE-3) and PDE-4, combining both bronchodilator and nonsteroidal anti-inflammatory effects in a single molecule. The drug is delivered through a standard jet nebulizer. In the phase 3 ENHANCE 1 and 2 trials, ensifentrine significantly improved lung function based on the primary outcome of average forced expiratory volume in 1 second (FEV1) within 0-12 hours of administration compared with placebo. In addition, patients were found to tolerate the inhaled treatment well, with similar proportions of ensifentrine- and placebo-assigned patients reporting treatment-emergent adverse events. The most common treatment-emergent adverse events were nasopharyngitis, hypertension, and back pain, reported in < 3% of the ensifentrine group. But as authors of the analysis from the Boston-based Institute for Clinical and Economic Review (ICER) found, the therapeutic edge offered by ensifentrine is outweighed by the annual wholesale acquisition cost that its maker, Vernona Pharma, has established: $35,400, which far exceeds the estimated health-benefit price of $7500 to $12,700, according to ICER. ICER is an independent, nonprofit research institute that conducts evidence-based reviews of healthcare interventions, including prescription drugs, other treatments, and diagnostic tests. "Current evidence shows that ensifentrine decreases COPD exacerbations when used in combination with some current inhaled therapies, but there are uncertainties about how much benefit it may add to unstudied combinations of inhaled treatments," said David Rind, MD, chief medical officer of ICER in a statement.

The Mixed Messages on Relationship Between COVID and Asthma

JUL 30 2024

In one of several recently published studies on the relationship between COVID-19 infection and asthma, asthma symptoms in children declined as the proportion of the US population vaccinated against COVID-19 increased, according to data drawn from the National Survey of Children's Health (NSCH). The inverse correlation between symptoms and vaccination was strong and statistically significant, according to investigators led by Matthew M. Davis, MD, Physician in Chief and Chief Scientific Officer, Nemours Children's Health, Wilmington, Delaware. "With each increase of 10 percentage points in COVID-19 vaccination coverage, the parent-reported child asthma symptoms prevalence decreased by 0.36 percentage points (P < .05)," Dr Davis and his coinvestigators reported in a research letter published in JAMA Network Open. The reduced risk of asthma symptoms with COVID-19 vaccination in children at the population level is just one of several recently published studies exploring the interaction between COVID-19 infection and asthma, but two studies that posed the same question did not reach the same conclusion. In one, COVID-19 infection in children was not found to be a trigger for new-onset asthma, but the second found that it was. In a third study, the preponderance of evidence from a meta-analysis found that patients with asthma — whether children or adults — did not necessarily experience a more severe course of COVID-19 infection than in those without asthma. The NSCH database study calculated state-level change in scores for patient-reported childhood asthma symptoms in the years in the years 2018-2019, which preceded the pandemic and the years 2020-2021, when the pandemic began. The hypothesis was that the proportion of the population 5 years of age or older who completed the COVID-19 primary vaccination would be inversely related to asthma symptom prevalence. Relative to the 2018-2019 years, the mean rate of parent-reported asthma symptoms was 0.85% lower (6.93% vs 7.77%; P < .001) in 2020-2021, when the mean primary series COVID-19 vaccination rate was 72.3%. The study was not able to evaluate the impact of COVID-19 vaccination specifically in children with asthma, because history of asthma is not captured in the NSCH data, but Dr Davis contended that the reduction in symptomatic asthma among children with increased vaccination offers validation for the state-level findings. "Moreover, the absence of an association of COVID-19 vaccination administered predominantly in 2021 with population-level COVID-19 mortality in 2020 serves as a negative control," he and his colleagues wrote in their research letter.

US FDA Approves Verona Pharma's Inhaled COPD Therapy

JUL 30 2024

The US Food and Drug Administration has granted approval to a treatment from Verona Pharma for a chronic lung disease that commonly affects smokers, the UK-based company said. The FDA's assent for the therapy, to be sold under the brand Ohtuvayre, is the company's first and provides a new inhaled non-steroidal treatment for chronic obstructive pulmonary disease. COPD, a chronic condition which causes restricted airflow and breathing problems, commonly affects cigarette smokers and is also known as "smoker's lungs". Other contributing factors for COPD include fumes, chemicals and dust in many working environments. It affects around 16 million Americans and is the sixth leading cause of death in the country, according to government data. Verona's application was backed by efficacy and safety data from two late-stage trials in which Ohtuvayre demonstrated improvements in lung function and symptoms, substantially reducing the risk of exacerbation in mild-to-severe COPD patients.

Measure Respiratory Signals with Insight

JUL 10 2024

Company Hans Rudolph announced new features for its SmartLab Instrumentation System with Insight software, a flexible data-acquisition system for use in making measurements of respiratory signals. It is a modular system that can be configured for a variety of measurements. The base module consists of a main system circuit board that can accept up to four sensor modules. It also has an input for a Nonin xPod oximeter and a Masimo IRMA CO2 concentration sensor. An optional internal oxygen concentration sensor is also available. Digital I/O ports with eight outputs and four inputs can be connected to a valve controller or other device that can accept TTL level digital signals. An optional analog output module is available for retransmitting up to 4 measured or calculated values. In addition to these standard applications, they have recently launched a new ECG Sensors and Module, Lung Compliance and Air Way Resistance Processor upgrade and MRI Compatible Pulse Oximetry and Respiratory Band Sensors and Modules. New features include ECG Modules for both 110V and 230V applications with three leads and upgradable sensors, lung Compliance and Airway Resistance Processor upgrade, and MRI Compatible Pulse Oximetry and Respiratory Band Sensors and Modules. The base unit holds up to 4 sensor modules. Differential pressure sensor modules with full scale ranges from 2 cmH2O to 350 cmH2O. Absolute pressure sensor modules for barometric pressure or altitude compensation. Up to 5 calibration tables for each sensor module. Two RS-232 serial ports for connection to an oximeter and CO2 sensor. Optional internal oxygen concentration sensor. Internal or external temperature and humidity sensor. Works with all the Hans Rudolph pneumotachs. Calculates tidal volume and several respiratory parameters from the flow and airway pressure signals. Data transmitted over USB or wireless connection. Up to 8 data channels at up to 200 Hz rate.

New Product Released

JUL 10 2024

Dale Medical Products, Inc., an industry leader in disposable medical products, announced the launch of its latest patent pending innovation, UltraGrip. This revolutionary NasoGastric Tube Holder sets a new standard in NG Tube Securement with its cutting-edge features and unparalleled performance. UltraGrip is the culmination of marketing research and engineering design. It represents Dale’s commitment to delivering innovative patient solutions with clinician inspired enhancements that meet the evolving needs of patients and clinicians. Key features of the UltraGrip 163 include: Universal Design which allows it to secure all types/sizes of NG tubes, breathable fabric with a patient friendly adhesive and non-adherent tipped ends, easy to use and understand single tab design, non-adherent, cushioned foam bridge pad which provides superior comfort at the tip of the nose to help prevent medical device related pressure injury (MDRPIs). “We are thrilled to introduce the UltraGrip Single Leg NG Tube holder to the healthcare market.  This new product is a great example of a clinical solution that satisfies the needs of patients and their caregivers,” said Bob Simpson, President & CEO. The 163 UltraGrip becomes available on or about July 15, 2024 through distributors worldwide. For more information about the 163 UltraGrip, visit the Dale Medical website at www.dalemedical.com.

Masimo Announces Sleep Halo, Advanced Sleep Analysis

JUL 1 2024

Masimo announced that the Masimo W1 Sport advanced health tracking wearable is gaining a powerful new feature: scientifically based sleep analysis with Sleep Halo. Sleep Halo offers overnight sleep data tracking with an unmatched 70,000+ daily measurements of second-by-second continuous health data. Sleep Halo uses continuous Masimo pulse oximetry and machine learning to provide meaningful insights into the quality of an individual’s sleep, including overall timing, duration of sleep stages, periods of rest and wakefulness, episodes of desaturation, and more. The nightly analysis, including a Sleep Halo score – an algorithmic calculation representing your overall sleep quality – is visualized on the companion Masimo Health smartphone app. The Sleep Halo score and sleep analysis will be featured in all future Masimo wearables, including the upcoming Masimo Freedom Watch and Band. Joe Kiani, Founder and CEO of Masimo, said, “We’re truly excited to launch Sleep Halo for Masimo W1 Sport. For 35 years, Masimo has been dedicated to using breakthrough engineering to help improve lives. Masimo W1 is unique among wearables in being able to continuously measure the wearer’s SpO2 and PR – and that gives us an opportunity to provide a truly informed, robust analysis of how one sleeps. As always, we are committed to providing scientifically backed measurements, which are based on our unmatched, accurate technology, not ‘tarot card logic’ novelties. We benchmarked Sleep Halo with EEG to confirm its stages of sleep are comparable to sleep analysis. We hope that with this new scientifically based Sleep Halo, our customers can improve their sleep hygiene, which has been shown to improve life.” Today’s consumers are limited to choosing from among a variety of consumer wearables, which use intermittent and often inaccurate data, heavily reliant on movement – which cannot provide reliable or actionable sleep metrics. Masimo W1 – which has been shown to be significantly more accurate than the leading consumer wearable – is designed to provide sophisticated and insightful sleep analysis using technology based on Masimo SET, the primary pulse oximetry technology at all top 10 U.S. hospitals as ranked in the 2024 Newsweek World’s Best Hospitals listing. Rigorously tested against reference laboratory measurements, including EEG data, Sleep Halo makes it possible to bring reliable, insightful sleep analysis to everyday people around the world, on a nightly basis, via a lightweight, comfortable wearable, from the convenience of their own home. Existing Masimo W1 Sport owners will soon be able to update their watch firmware and Masimo Health app to begin their sleep tracking journey. Masimo W1 is available for purchase at www.Masimo.com. Also available is Masimo W1 Medical, the first and only FDA-cleared watch to provide continuous, real-time SpO2 and PR with an indicator when measurements are outside of their normal ranges. Masimo W1 Sport and Sleep Halo are for general health and wellness purposes.

More Evidence PTSD Tied to Obstructive Sleep Apnea Risk

JUN 28 2024

Posttraumatic stress disorder (PTSD) may enhance the risk for obstructive sleep apnea (OSA) in older male veterans, the results of a cross-sectional twin study suggested. However, additional high-quality research is needed and may yield important mechanistic insights into both conditions and improve treatment, experts said. In the trial, increasing PTSD symptom severity was associated with increasing severity of OSA, even after controlling for multiple factors. "The strength of the association was a bit surprising," study investigator Amit J. Shah, MD, MSCR, Emory University, Atlanta, said. "Many physicians and scientists may otherwise assume that the relationship between PTSD and sleep apnea would be primarily mediated by obesity, but we did not find that obesity explained our findings." "Prior studies have shown an association between PTSD and sleep apnea, but the size of the association was not as strong," Shah said, possibly because many were based on symptomatic patients referred for clinical evaluation of OSA and some relied on self-report of a sleep apnea diagnosis. The current study involved 181 male twins, aged 61-71 years, including 66 pairs discordant for PTSD symptoms and 15 pairs discordant for PTSD diagnosis, who were recruited from the Vietnam Era Twin Registry and underwent a formal psychiatric and polysomnography evaluation as follow-up of the Emory Twin Study. PTSD symptom severity was assessed using the self-administered Posttraumatic Stress Disorder Checklist (PCL). OSA was mild in 74% of participants, moderate to severe in 40%, and severe in 18%. The mean apnea-hypopnea index (AHI) was 17.7 events per hour, and the mean proportion of the night with SaO2 less than 90% was 8.9%. In fully adjusted models, each 15-point within-pair difference in PCL score was associated with a 4.6 events-per-hour higher AHI, a 6.4 events-per-hour higher oxygen desaturation index, and a 4.8% greater sleep duration with SaO2 less than 90%. A current PTSD diagnosis is associated with an approximate 10-unit higher adjusted AHI in separate models involving potential cardiovascular mediators (10.5-unit; 95% CI, 5.7-15.3) and sociodemographic and psychiatric confounders (10.7-unit; 95% CI, 4.0-17.4). The investigators call for more research into the underlying mechanisms but speculate that pharyngeal collapsibility and exaggerated loop gain, among others, may play a role. "Our findings broaden the concept of OSA as one that may involve stress pathways in addition to the traditional mechanisms involving airway collapse and obesity," Shah said. "We should be more suspicious of OSA as an important comorbidity in PTSD, given the high OSA prevalence that we found in PTSD veterans."

Masimo and Cleveland Clinic Collaborate to Improve Hospital Remote Care

JUN 27 2024

Masimo, a leading global provider of medical technology and hospital automation solutions, and Cleveland Clinic, a nonprofit academic medical center, announced today the launch of a new partnership centered around hospital-based remote patient monitoring (RPM), including TeleCritical Care. This will include the integration of Cleveland Clinic’s critical care (eHospital) and non-critical care (eCMU) central patient monitoring platforms with the Masimo Hospital Automation platform. The goal is to provide tools for clinicians that offer enhanced situational awareness and clinical decision-support for hospitalized patients, including the critically ill. The collaboration will include joint development initiatives on predictive analytics and AI-based algorithms for improving cardiac care. Cleveland Clinic’s existing critical care and non-critical care central monitoring platform provides continuous monitoring of a range of vital signs, including ECG, for both ICU and non-ICU patients at more than a 2,000-bed capacity. Its hospital-based RPM programs serve 11 hospitals, providing intensivist monitoring, 24/7 critical care nursing, and patient management. Cleveland Clinic’s programs have reduced patient mortality and reduced ICU length of stay while increasing caregiver satisfaction. With this partnership, Masimo and Cleveland Clinic hope to bring these innovations and patient benefits to other healthcare systems in the future. The aim of the enhanced program is to increase awareness and facilitate triage with proactive responses to changes in a patient’s condition. This improves patient care and saves lives by ensuring the highest risk patients are identified and receive timely treatment while maintaining quality of care for all patients. The Masimo Hospital Automation platform offers technologies designed to help clinicians improve patient care at the bedside, across the care continuum. Masimo Hospital Automation includes monitoring and wearable technologies, high-fidelity medical device integration, system-wide applications for surveillance and data visualization, and novel AI capabilities that support intelligent patient prioritization and help clinicians identify changes in patients’ condition more efficiently. These decision-support tools are integrated into the Masimo Hospital Automation platform and utilize the Halo engine, technology which identifies deterioration patterns in multiple physiological parameters simultaneously, in real time. The Halo tools include Halo ION, a comprehensive, scalable, and customizable continuous early warning score to help streamline patient assessment and clinical workflows. As part of their work together, Masimo and Cleveland Clinic are partnering to jointly develop an additional Halo-based decision-support tool to support clinicians with earlier detection of adverse events – ultimately helping them manage and improve patient outcomes more effectively, for low-, mid-, and high-acuity patients. “We see great opportunities to enhance remote care, particularly for critically ill individuals,” said Chiedozie Udeh, M.D., Medical Director of ICU Operations at Cleveland Clinic. “By combining our technical and clinical expertise, we aim to improve situational awareness for clinicians and continue to improve outcomes for patients.” Thomas Callahan, M.D., Staff Cardiologist at Cleveland Clinic’s Heart, Vascular & Thoracic Institute, and principal investigator for the AI study, added, “We look forward to exploring the effects of next-gen inpatient wearables, and as the capabilities of AI continue to advance, studying the potential impact on the care of cardiac patients, including those undergoing cardiac surgery.” Joe Kiani, Founder and CEO of Masimo, said, “We are truly honored to have the opportunity to partner with Cleveland Clinic to advance patient care. By harnessing Masimo’s AI-powered decision support tools, automation solutions, and monitoring devices, alongside Cleveland Clinic’s vast clinical expertise and dedication to providing the highest quality, most innovative care, our partnership has the potential to significantly ease staff shortages, better standardize care, and promote intensivist- and specialist-led care. Ultimately, we will make significant strides in shifting from reactive to predictive and proactive care – improving patient outcomes, safety, and quality of care across the board.” Dr Chiedozie Udeh has a conflict of interest with Cleveland Clinic’s eHospital platform and may benefit from commercialization of eHospital technology developed by the Company. These financial interests are being managed by Cleveland Clinic and are within permissible limits established by the Institutional Conflicts of Interest Policy. eHospital is not a Masimo product.

RT Companies Issue Mission Statement

JUN 26 2024

React Health and ReactDx, leading companies in respiratory, sleep, and cardiac care, announced the adoption of new, joint mission and vision statements that underscore their commitment to optimizing individuals' well-being through pioneering advanced diagnostics and therapeutics. The new mission, "To improve the lives of those we serve by delivering an innovative continuum of diagnostics and medical devices, with excellent respiratory, sleep and cardiac care.” In addition to the new mission statement, React Health and ReactDx have articulated a bold new vision: "To seamlessly integrate end-to-end quality diagnostic medical device and service products to become the cost-effective standard in the detection, prevention, treatment and monitoring of respiratory, sleep, and cardiac conditions by removing barriers informed by the experiences of patients and customers." "With these new mission and vision statements, we are setting a clear direction for the future," said Dr Colleen Lance, Chief Medical Officer. "Our focus is on pioneering advanced diagnostics and therapeutics, and this mission encapsulates our dedication to optimizing the well-being of individuals and uplifting the quality of life for those in our care. Our vision further reinforces our aspiration to revolutionize holistic care and ensure universal access to innovative health solutions." The development of the new mission and vision statements was a comprehensive process that involved input from various stakeholders, including employees, patients, and industry experts. This initiative is part of the company’s broader strategy to enhance patient care through innovation and excellence. "We believe this mission and vision will inspire our team and resonate with our providers and patients," added Bill Shoop, Chief Executive Officer. "They capture the essence of who we are and where we are headed, emphasizing our commitment to respiratory, sleep, and cardiac care, as well as our broader goal of revolutionizing holistic care."

Rheumatoid Arthritis Disease Activity Impacts Severity of Associated Interstitial Lung Disease

JUN 14 2024

New findings reveal that rheumatoid arthritis (RA) disease activity significantly affects the severity of interstitial lung disease (ILD), both radiologically and physiologically, in patients with RA and comorbid ILD.Impaired pulmonary function negatively affects the survival of patients with RA-ILD, making it necessary to evaluate the effect of RA disease activity on the severity of ILD. Researchers assessed the associations between RA disease activity and ILD severity in 124 patients with RA (median age, 70.0 years; 25.8% men; median disease duration, 2.92 years) who visited a rheumatology center between December 2020 and March 2023. ILD severity was determined using high-resolution computed tomography (HRCT), with scores ranging from 0% (no involvement) to 100% (all lung fields affected), and pulmonary function tests such as forced vital capacity (FVC) and predicted FVC%. RA disease activity was assessed using the Disease Activity Score in 28 joints calculated with erythrocyte sedimentation rate (DAS28-ESR) and the Clinical Disease Activity Index (CDAI). HRCT revealed that 17 patients had ILD, with ILD severity being mild (< 10% lung involvement), moderate (≥ 10% to < 20%), or severe (≥ 20%) in 7.2%, 2.4%, and 4.0% patients, respectively. Both rheumatoid factor titer (standardized coefficient, 0.247; P = .01) and DAS28-ESR (standardized coefficient, 0.199; P = .03) were significantly associated with the radiological quantitative severity of ILD. Additionally, DAS28-ESR showed a significant association with predicted FVC% (standardized coefficient, −0.230; P = .047); however, no significant association was observed with CDAI.

Bronchial Rheoplasty Unplugs Mucus in Patients With Chronic Bronchitis

JUN 14 2024

Bronchial rheoplasty (BR) significantly reduced mucus plugging in adults with chronic bronchitis (CB), based on new data presented at the American Thoracic Society International Conference. "Mucus plugging, opacities within the lumen of an airway seen on CT scan, is a relatively new measure in COPD that physicians are investigating," lead author Victor Kim, MD, of Temple University Hospital, Philadelphia, said. "These mucus plugs are comprised of excess mucus that cannot be expelled and obstruct the airway from participating in ventilation," he said. Previous research has shown an association between mucus plugging seen on chest CT and increased all-cause mortality, Kim and colleagues wrote in their abstract. "Mucus plugs can lead to airflow obstruction, hypoxia, exacerbation of COPD, and infection of the lower respiratory tract," Kim said. "The presence of mucus plugging has been related to increased mortality and increased exacerbations, and reducing or eliminating them is associated with clinical improvements in asthma," he said. CB is also associated with mucus plugs, and BR has been shown to improve CB symptoms that can last up to at least a year, he noted. Therefore, Kim and colleagues hypothesized that BR could also reduce mucus plugs. The researchers recruited 52 adult patients with symptomatic CB (defined as Chronic Obstructive Pulmonary Disease [COPD] Assessment Test cough and phlegm scores > 7) who underwent bilateral BR procedures. CT was performed prior to the BR procedure and 6 months after the completion of the BR. The BR procedure involves nonthermal ablation of the airway epithelium and submucosa with pulsed electric fields, the researchers wrote in their abstract. Mucus plugging was defined as the occlusion of a segmental airway and was assessed as the number of airway segments (out of a total of 18) with one or more mucus plugs. The mean number of airway segments with mucus plugging was 2.9 out of 18 possible segments. A total of 35 patients (67%) showed mucus plugging before the intervention, and 17 did not, despite significant self-reported baseline CB symptoms, the researchers noted. Among the patients with baseline mucus plugging, the mean mucus plugging score decreased by approximately one segment from 4.3 to 3.4 after the procedure (P = .0392). More than half of the patients with mucus plugging (20 patients, 57%) improved by one segment or more. In addition, distal airway volume increased by 7.4% at follow-up, and total airway count increased by 4.9 airways. In patients without baseline mucus plugging, 65% continued to have no mucus plugging at 6 months' follow-up. Overall, changes in CT measures were consistent with changes in symptom improvement, with mean changes from baseline to follow-up of −6.8 points and 14.5 points on the COPD Assessment Test and St. George's Respiratory Questionnaire, respectively.

Understudied Patients With COPD Benefit From Bronchoscopic Lung Reduction

JUN 14 2024

Bronchoscopic lung volume reduction (BLVR) significantly improved lung function in a subset of patients with chronic obstructive pulmonary disease (COPD) with alpha-1 antitrypsin deficiency (AATD), based on data from more than 200 individuals. BLVR has shown promising results in previous studies for carefully selected patients with COPD, said Michael J. Nicholson, DO, of Temple University Hospital, Philadelphia. However, those with AATD have often been excluded from large BLVR trials, so data on its effectiveness in this population are limited, he said. "The distinct pathophysiology of AATD poses challenges in extrapolating findings from trials involving COPD patients without AATD," Nicholson noted. "Variations in affected lung lobes and disease progression are major differences between the AATD and non-AATD populations; we sought to examine if BLVR could provide significant, sustained benefit to AATD patients despite their differences from the typical COPD cohort," he said. In a study presented at the American Thoracic Society (ATS) 2024 International Conference, Nicholson and colleagues reviewed data from 238 adults with COPD including 14 with AATD who underwent BLVR at a single center between August 2018 and December 2022. Pulmonary function test data were collected at baseline and at a median of 7 months post-BLVR. The mean age of patients with AATD was 61.5 years, and 79% were men. The primary outcome was the percentage of patients with forced expiratory volume per second (FEV1) improvement greater than 15%. Half of the patients with AATD achieved this outcome, with a median improvement in FEV1 of 110 mL and a significant difference in pre- and post-BLVR FEV1 volume based on a Wilcoxon signed rank test (W = 11.5; P < .05). Patients with AATD also showed significant improvement in several secondary outcomes including BODE index, residual volume (RV), total lung capacity (TLC), RV/TLC ratio, and inspiratory capacity/RV ratio between pre- and post-BLVR.

New Test Receives Approval

JUN 13 2024

Roche announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, an automated multiplex real-time polymerase chain reaction (RT-PCR) assay on the cobas liat system. Producing results in just 20 minutes on a compact analyser suitable for most healthcare settings, the test uses either a single nasopharyngeal or anterior nasal-swab sample to confirm or rule out infection with SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV). “Diagnostics play a critical role in the fight against respiratory illness,” said Matt Sause, CEO of Roche Diagnostics. “We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.” Introducing rapid multiplex PCR diagnostic tests into near-patient care environments such as emergency departments, urgent care facilities, and physician office labs has the potential to provide swift and precise results, expediting clinical decision-making processes. This approach can help reduce unnecessary antibiotic usage, facilitate targeted treatment strategies, and ultimately enhance patient outcomes and healthcare system efficiency. According to the US Centers for Disease Control and Prevention (CDC), respiratory diseases in the United States reached high levels during the most recent autumn and winter seasons, with SARS-CoV-2 causing the most emergency department visits. Hospitalisations due to respiratory illness place a strain on hospitals and can result in delayed diagnosis and treatment for patients. In the 2023-2024 respiratory season, infants, children, and adults ages 65 and older were observed to have the highest rates of emergency department visits and hospitalisations caused by SARS-CoV-2, influenza, and RSV. Nationwide, the percentage of recent total deaths due to these respiratory viruses was highest among patients 65 and older. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test authorised for emergency use further expands and complements Roche’s broad portfolio of single and multiplex tests intended to help diagnose and address the needs of patients presenting with symptoms of respiratory illness, including the following assays: cobas SARS-CoV-2, cobas Strep A, cobas SARS-CoV-2 & Influenza A/B, and cobas Influenza A/B & RSV for use on the cobas liat system. In 2025, Roche intends to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for the new test, with plans for commercial launch in other markets worldwide following CE-IVDR approval. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza and RSV can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is authorised for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Results are for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV viral RNA in clinical specimens and are not intended to detect influenza C virus. SARS-CoV-2, influenza A, influenza B and RSV RNA are generally detectable in nasal swab and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent detected may not be the definitive cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas liat system and the cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

O2matic’s Proprietary Technology to be Evaluated by the University of Colorado

JUN 7 2024

O2matic, a Danish medical device company focused on developing next-generation oxygen therapy and monitoring technologies, has announced that its proprietary technology is the subject of research led by Adit Ginde, MD, Professor of Emergency Medicine and Anesthesiology at the University of Colorado School of Medicine. Dr Ginde and his team’s work has paved the way for the SAVE-O2 trial, a multicenter randomized clinical trial funded by the US Department of Defense. The SAVE-O2 trial focuses on redefining oxygen requirements in critically ill trauma patients through targeting normoxemia. Preliminary results from analyzing data from approximately 12,000 randomized patients have unveiled promising outcomes. Manually targeting normoxemia successfully reduces hyperoxemia without increasing hypoxemia, resulting in lower mortality rates, shortened hospital stays, and decreased supplemental oxygen requirements. Dr Ginde presented initial results at the Military Health System Research Symposium in 2023, earning his team the distinguished recognition of Outstanding Research Accomplishment. Their advancements in oxygen therapy protocols have already begun to influence guidelines, with updates to 10 relevant Joint Trauma System guidelines. Dr Ginde and his team are now evaluating the efficacy of automatic oxygen therapy technology, with O2matic’s proprietary technology chosen for a multi-center study involving 300 patients. This study, named SAVE-O2 AI, and initiated in May 2024, aims to publish results by early 2026. “We at O2matic are deeply honored to be part of this significant study and eagerly anticipate the potential impact of our technology on acute and trauma patients,” said Arnt Lund, O2matic’s CEO. “We are also grateful to the IDE sponsor for this study, IDTS Medical, Inc. and its CEO, Mario Nozzarella, who guided us through the US Food and Drug Administration Investigational Device Exemption (US FDA IDE) process and received our final (non-conditional) letter regarding the submission G230325/A001 with a strong sense of urgency.” The award is funded by the US Department of Defense through the Medical Technology Enterprise Consortium (MTEC) to further oxygen research using autonomous solutions.

IntelliPAP Option Released by React Health

JUN 4 2024

React Health, a sleep and respiratory device manufacturer and distributor, announced the release of the IntelliPAP option for the V*Home, V+Pro, V+C and VC+Pro ventilators. IntelliPAP is an optional tool that physicians may use when providing noninvasive ventilation in diseases that are associated with both respiratory insufficiency and obstructive sleep apnea (OSA). It enables the automatic adjustment of delivered PEEP levels in response to the detection of sleep disordered breathing (SDB) events. As an added safeguard, clinicians can limit the range of the automatic PEEP adjustment by setting the PEEP min and PEEP Max settings. “React Health is committed to advancing healthcare solutions that contribute to improved patient outcomes and operational efficiency. The most recent launch of IntelliPAP along with the new E0468 HCPCS code for our V+C ventilator with integrated cough assist (ICAT), further reflects that commitment to our partners and patients,” said Jeff Ward, EVP of Ventilation for React Health. React Health is a sleep and respiratory company based in the United States. For more information on the launch of the IntelliPAP, reach out to your local React Health sales representative or ventec-info@reacthealth.com.

Product Line Acquired

MAY 31 2024

Respiralogics announces the Asset Purchase of the Children’s Health First Product Line, a Carlsbad, CA company. Respiralogics, a leader in Bubble CPAP and Non-Invasive Respiratory Support of the Newborn, is proud to expand their product portfolio with the StatStrap Neonatal Positioning Strap, Preemie Beenie Poly Lined-Knit Hats and StatStrap Circuit Holder. These quality products fulfill unique niches to help bedside and transport clinicians with ELBW and full-term infants. StatStrap is a single patient-use safety strap set that safely secures and positions newborn infants within an incubator. It easily and securely attaches to the mattress tray of the incubator. StatStrap helps to prevent accidental falls of preterm and term infants receiving care in an incubator. Preemie Beenie is a specially designed Poly-Lined Knit Cap designed for ELBW and Term Infants to aid in their thermoregulation. The snug fit of the soft knit minimizes movement, pressure on the head and color-coded to easily identify the size of the Preemie Beenie StatStrap Circuit Holder assists in keeping tubing’s securely attached to the bed clothes for stability and/or the parent during Kangaroo Care. All products are made in the USA, designed for single patient use and Latex Free. Respiralogics specializes in providing innovative respiratory care products to meet the challenging needs of respiratory patients, especially the most vulnerable preterm infants. To benefit clinicians, we have joined with leading specialty respiratory distributors to provide expert local assistance and the training required for successful implementation of our products. Respiralogics’ complete line of products is available from Respiralogics and our specialty respiratory care distributors. Respiralogics, Respiralogics Logo, Preemie Beenie are trademarks and StatStrap is a registered trademark of Global Respiratory Solutions, Inc.

Breas Medical, Inc. Partners with VGM and Associates

MAY 30 2024

Breas Medical, Inc., a global leader in home mechanical ventilation and sleep therapy, announces that it has executed a vendor partner agreement with VGM and Associates, the nation’s largest and most comprehensive Member Service Organization (MSO) for post-acute healthcare. The partnership allows Breas to connect with and support the VGM membership, ultimately helping patients receive the highest level of care. This aligns with Breas’ mission to improve the quality of life and care of respiratory patients around the world through a personal commitment to innovation, quality, and customer focus. “We are honored to be able to partner with VGM and Associates,” said Chris Southerland, General Manager of Breas Americas, Breas Medical, Inc. “This exciting opportunity allows us to share our expertise in ventilation with the VGM membership and continue to provide support to the industry with our innovative life support ventilation units that set the standard in clinical workflow, technology, and patient comfort and mobility.” “We are thrilled to announce a partnership between Breas Medical and VGM and Associates, uniting two leaders in healthcare innovation,” said Boone Lockard, VP of Clinical Services, VGM and Associates. “This collaboration is set to enhance the quality of care for patients across the US, leveraging Breas Medical’s expertise in respiratory care and sleep apnea treatment with VGM’s business solutions.” (MSO) for post-acute healthcare including DME/HME, respiratory, sleep, wound care, complex rehab, women’s health, home modifications, and orthotics and prosthetics providers. 3,000 providers with nearly 7,000 locations rely on VGM to connect them to valuable resources every single day. For more information, visit www.vgm.com.

New Research Provides Evidence of the Effectiveness and Critical Role of Positive Airway Pressure Therapy

MAY 25 2024

A number of accomplished medical and scientific experts presented critical new research on sleep conditions and their effect on cardiovascular health at the American Thoracic Society International Conference. The ResMed-supported research provided new insights into the effectiveness of PAP therapy in treating sleep-disordered breathing and its associated clinical benefits. The studies were among 26 supported by ResMed in collaboration with leading scientists including Michael Arzt, MD, Universitätsklinikum Regensburg, Germany; Jean-Louis Pépin, MD, Grenoble Alpes University, France; Atul Malhotra, MD, University of California, San Diego; and Holger Woehrle, Ulm Lung Centre, Germany. With growing attention on the use of anti-obesity medications, such as GLP-1s in clinical practice, a timely study was presented by Dr Atul Malhotra which explored the real-world relationship of GLP-1 medication use and PAP therapy in patients with OSA. The use of GLP-1s did not lead to higher discontinuation rates of PAP therapy, rather this analysis found that patients who were adherent to their GLP-1 medication had higher levels of PAP therapy use than those who were non-adherent to their GLP-1 medication. Several studies demonstrated findings showing continued effectiveness of PAP therapies for patients with sleep disorder conditions like obstructive sleep apnea. Among these was an analysis of data from 27 randomized control trials and non-randomized control studies on the effects of PAP on patients with OSA. This meta-study, presented by Dr Atul Malhotra, found mortality was 37% lower on average in patients with PAP-treated OSA vs untreated OSA. An additional study, presented by German physician and sleep researcher Holger Woehrle, looked at 17,000 treatment-naïve patients in both PAP-treated and untreated cohorts and showed PAP treatment reduces hospitalization in patients with OSA over the first four years of treatment. This finding demonstrates a correlation between the use of PAP therapy and a reduction in use of healthcare resources. A study presented by ResMed’s research scientist Elroy Boers projected an increase in OSA cases in the United States using patient data calibrated across subgroups of age, sex and body-mass index (BMI). According to this research, due to the growing and aging population in the United States as well as increased BMI trends, the already substantial burden of OSA is expected to increase by 27.6% by 2050 in men and women aged 30-70, with an overall prevalence within this group projected to be 26%. As OSA continues to increase, reliance on PAP therapy will rise as it remains the gold standard for treatment. Two studies evaluated the effects of Adaptive Servo-Ventilation (ASV) therapy in two populations, patients with TE-CSA and patients on long-term opioid therapy. The former, presented by German physician and sleep researcher Dr Michael Arzt, demonstrated ASV therapy showed a reduced symptom burden and an improvement in quality of life for patients with TE-CSA, with or without comorbid cardiovascular disease, a comorbidity present in a majority of patients with TE-CSA. The second study, presented by French physician and researcher Dr Jean-Louis Pépin, studied 86 CSA patients on long-term opioid therapy and who used ASV treatments for at least one year. This study showed a -1 median reduction in Epworth Sleepiness Scale (ESS) values and a median increase of .96 on the Functional Outcomes of Sleep Questionnaire (FOSQ), demonstrating a lower symptom burden and improved quality of life. Another study, also presented by Dr Jean-Louis Pépin, looked at nearly 50,000 adults with COPD who were treated via domiciliary NIV. The study showed long-term home use of NIV was strongly associated with a reduced risk of death. “The host of critical research presented by influential and accomplished experts at ATS continues to show the effectiveness and importance of PAP in treating sleep disordered breathing and limiting their impact on adverse health effects,” said Carlos M. Nunez, MD, Chief Medical Officer at ResMed. “The increasing prevalence of cardiovascular conditions, obesity and an aging population in the United States demonstrate why increasing awareness of sleep health and conducting research into how best to improve sleep quality and overall health outcomes is so critical today.” In addition to the ResMed-supported abstracts, Dr Nunez served as a panelist at two ATS sessions: The Healthcare of Today, Looking Towards Tomorrow: Digital Innovations and Patient Centricity, which examined the imperative for investing in digital health and driving innovations for personalized patient experiences, as well as Enabled Clinicians, Enhanced Care: Best Practices for Leveraging Digital Health Solutions, which showcased how digital health solutions and digital therapeutics can find a place in today’s clinical workflows. ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

Clinical Innovator and Educator Joins Editorial Advisory Board of Neonatal Intensive Care and Respiratory Therapy

MAY 8 2024

Kristin King, PhD, CCC-SLP, Vice President of Clinical Education and Research for Passy-Muir Inc., has joined the Editorial Advisory Board (EAB) of Neonatal Intensive Care and also of Respiratory Therapy—bringing along years of expertise in developing clinical innovations that have produced improvements in both industries.

Dr King brings a wealth of experience to NIC and RT. She is currently on the EAB of the American Speech, Language and Hearing Association (ASHA) Perspectives. She also has received the ACE Award for Continuing Education in four separate years and is ASHA-certified for Clinical Competence in Speech-Language Pathology.

During her time in academia, Dr King was also awarded a William Webster Endowment Fund Award for Neuroscience Research, and several other grants to support her research in the field of neuroscience, including impacts on language and cognition following traumatic brain injury.

“Disseminating quality clinical/medical information is something I feel strongly about,” said Dr King.

Dr King has been an adjunct professor, assistant professor, and clinical instructor at multiple prestigious schools. Since 2008, she has also been a consultant to multiple universities and groups for her expertise in sports concussions and in tracheostomy and speaking valve use, a medical expert witness related to traumatic brain injury in pediatrics and adults, and a published author and national/international speaker on topics related to tracheostomy/mechanical ventilation and speaking valves. Her current role has her providing clinical oversight regarding continuing education, research literature reviews, research, product development, and clinical practice guidelines.

Medixine and Nonin Medical partner to co-develop remote digital monitoring services

APR 23 2024

Finnish health tech company Medixine has strengthened its presence in the US market, announcing a deepened technological partnership with Nonin Medical, a leading manufacturer of wearable and noninvasive medical monitoring devices. With the US market for remote patient monitoring expected to exceed USD 25 billion by 2028, the collaboration is an important milestone in Medixine’s continued US growth. An aging population and pressure to reduce costs are accelerating digitalization in the health sector. Remote patient monitoring has been steadily gaining prevalence as an effective and efficient healthcare solution for common chronic diseases, including diabetes, heart disease, respiratory issues, and COPD. It is estimated that chronic diseases account for approximately 86% of the total healthcare costs in the United States, with similar figures recorded worldwide. These impacts and costs are projected to rise for years to come. “In deepening our partnership with Nonin Medical, we’re setting ambitious goals together to bring remote digital care’s substantial benefits to both patients and clinicians across the United States. The U.S. is an important market for Medixine; demand for remote patient care is high, as there are often vast distances between patients and healthcare providers,” said Lasse Rousi, CEO at Medixine. “Furthermore, it’s especially significant for us that a renowned market leader like Nonin Medical has chosen our remote patient monitoring platform for its first transition from devices into digital services.” The new partnership is set to combine Medixine’s digital remote patient monitoring software platform with Nonin’s U.S. market-leading pulse oximetry devices. The collaboration highlights how integrating physical devices with software-driven solutions has the potential to significantly improve patient comfort, convenience, and care quality, while also reducing the burden on overworked clinicians and under-resourced care providers by reducing the number of unnecessary hospital visits. “At Nonin Medical, we have an extensive background in producing first-class pulse oximetry devices in terms of hardware, including several industry-firsts,” said Aaron Lobbestael, Sr. Director of Advanced Technology at Nonin Medical. “But to unlock their full potential in the world of digital healthcare, devices need to be paired with an equally reliable and robust software platform; we see Medixine as the perfect fit, and they align with our objectives to deliver the most patient-centric care possible.” One significant area the collaboration aims to progress is overnight oximetry during sleep, for example, as pre-screening to determine if patients need and qualify for supplemental oxygen. Such sleep screenings can also determine if patients need to be tested further for potential sleep disorders like obstructive sleep apnea. This chronic condition is estimated to affect up to 30 million people in the U.S., with only 6 million of these clinically diagnosed. Left untreated, the condition can lead to an increased risk of high blood pressure, heart disease, Type 2 diabetes, stroke, and depression. “Combining physical monitoring devices with Medixine’s digital platform offers huge potential benefits in understanding the need for overnight oxygen,” Lobbestael continues. “At present, it may take months to acquire an accurate reading using overnight devices that patients need to take to and from the health care provider multiple times. Our digital solution would require just one night of measurement, which would be downloaded automatically to the patient’s records. By digitizing our healthcare services, patients can access all the same services they have received previously, but much more easily, while clinicians’ workflows are made significantly more efficient.” Lobbestael concludes.

Company Set For Conference

MAR 4 2024

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 the ATS 2024, scheduled to be held in the beautiful downtown San Diego Convention Center.” Last year over 10,300 professionals attended, 28% of which were international. This will be ECO PHYSICS, INC.’s 24th 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 11,000 of these respiratory professionals chose to attend, present, and learn about the latest advances. This year’s Conference will be held May 13th-18th. ECO MEDICS offers a broad range of research Pulmonary Function Testing (PFT) capabilities, including Lung Clearance Index (LCI). The EXHALYZER D provides sensitive multiple breath washout measurements, revealing detailed information on the small airways. The Analyzer CLD 88sp instrument is used for exhaled nitric oxide (FeNO), alveolar (AlvNO), and nasal (nNO) measurements.

Advances in Integrated Cough Assist Technology

MAR 1 2024

React Health, a sleep and respiratory device manufacturer and distributor, announced the final ruling for new HCPCs code, E0468, which has been granted exclusively to the React Health V+C Ventilator with Integrated Cough Assist Technology ICAT. The new billing code addresses the evolving needs of the medical community by providing a standardized and comprehensive system which combines two leading respiratory treatments into one device. The React Health V+C ventilator delivers invasive, noninvasive and mouthpiece ventilation as well as High Flow Therapy and integrated cough to adult and pediatric patients weighing at least 5 kg. The advanced unified respiratory system combines responsive leak and circuit compensation as well as precision flow trigger controls to enable comfortable breathing and accurate therapy. This breakthrough code aims to simplify billing procedures, reduce administrative burdens, and most importantly, improve patient care while ensuring access to several key features: By unifying ventilation and cough into one system, it now takes seconds instead of minutes to administer cough therapy with Integrated Cough Assist Technology ICATTM; cough is activated with the touch of a button to make airway clearance easy, synchronizing with the patients breathing pattern ensures uninterrupted ventilatory support and enhanced patient comfort; during invasive ventilation, patients remain connected to the ventilator at all times, and there is no need to disconnect circuits between mechanically assisted coughs; designed to elevate the patient experience, enhance comfort, and increase the utilization of cough assistive therapies all within one device. “React Health is committed to advancing healthcare solutions that contribute to improved patient outcomes and operational efficiency. The introduction of E0468 aligns with our mission to empower healthcare providers with tools that simplify processes and enhance overall patient care,” said Megan Carpenter, VP of Ventilation Sales for React Health.

Dräger receives Frost & Sullivan’s 2024 Best Practices Company of the Year Award

FEB 27 2024

Dräger, an international leader in medical and safety technologies, announced that Frost & Sullivan has selected the company for its 2024 Best Practices Company of the Year Award in the global respiratory care devices industry. Frost & Sullivan’s selection process involves identifying companies that consistently develop growth strategies based on a visionary understanding of the future and effectively address new challenges and opportunities employing best practices and strategic analytics across a value chain. “Today’s healthcare decision makers are looking beyond devices to determine the value a product brings to their critical care environments,” said President and CEO for Draeger, Inc., Lothar Thielen. “This award validates Dräger’s approach of combining best-in-class products, cost-effective accessories, and service solutions – which together deliver unmatched value to the hospitals we support.” Addressing hospital needs by offering easy-to-use and cost-conscious solutions According to Utkarsha Soundankar, senior research analyst at Frost & Sullivan, “Dräger has become one of the leading respiratory device vendors for its enhanced clinical outcomes, product quality, longterm customer support, and ongoing education tools, all of which assist in offering patient safety and enhanced care.” Dräger developed its new Evita V600, V800 and Babylog VN800 ventilators based on customer requirements for improving patient safety, patient outcomes, and hospital workflow. These devices can provide various modes of ventilation – such as high-flow O2 therapy, non-invasive ventilation, and invasive ventilation modes – using the same accessories. This eliminates the need to use multiple devices for critically ill patients who require different types of respiratory support, thereby streamlining workflow and reducing equipment costs. Providing visionary scenarios through mega trends Frost & Sullivan salutes Dräger for introducing first-to-market solutions and continually investing in the development of new technologies. One such example is Dräger’s research collaboration with STIMIT for the investigation of ventilator-induced diaphragmatic dystrophy (VIDD). STIMIT is developing noninvasive diaphragm stimulation for preserving diaphragm thickness. An FDA-approved clinical trial for this emerging technology began in January 2024. Fostering excellent customer ownership and service experiences Used by leading hospitals worldwide, Dräger’s respiratory devices are clinically validated, with detailed consideration for the hospital’s specific application. To support hospital infection control protocols, Dräger designs its devices with smooth services and minimal nooks that can harbor infectious agents. The company has also developed an extensive line of single-patient use and reusable valves. Frost & Sullivan cites Dräger’s best-in-class services, a network of over 3000 technicians, remote service, 24/7 hotline support, and exceptional service follow up. The company also offers webinars and training classes for healthcare facilities that want to manage their own programs. Dräger has a strong leadership team and actively supports the respiratory care community. As of 2023, Dräger donated more than 150 ventilators to respiratory schools in the United States to train the next generation of therapists and will donate another 185 ventilators in 2024.

Spirometer Receives Approval from China’s NMPA

FEB 14 2024

Monitored Therapeutics, Inc. (MTI), a Remote Patient Monitoring company, announced the approval of its GoSpiro spirometer by China’s FDA equivalent, NMPA. MTI has partnered with Shenzhen based Spiritumtec Ltd, a Chinese company with a history of producing high-quality respiratory products to manufacture and market the GoSpiro in China. The founders of Spiritumtec have previously worked for VIASYS Healthcare alongside of the founders of MTI, building a strong long-term relationship. The version of the GoSpiro approved for sale in China will be manufactured by Spiritumtec under a licensing agreement with MTI. “The approval of the GoSpiro in China will amplify MTI’s reach for supporting clinical trials for the pharmaceutical industry in China where there is a great need for validated spirometers for home monitoring,” said Alex Stenzler, Chief Science Officer for MTI. "The manufacturing line in China will increase the production capabilities of spirometers to supplement MTI’s production needs in the US." Monitored Therapeutics is a digital health company built to empower providers with end-to-end solutions to easily evaluate, monitor, and care for their patients. Our solutions focus on the respiratory care continuum - not just a portion of it - so providers can deliver the best care for patients no matter where they are in their healthcare journey and how it evolves. The company’s mission is to improve the quality of life of respiratory patients by increasing patient engagement, promoting drug adherence while simultaneously reducing healthcare costs.

Pulse Oximetry Device Measures Accurately on Both Black and White People Even During Low Perfusion: Study

FEB 9 2024

Masimo announced the findings of a retrospective, peer-reviewed study published in the Journal of Clinical Monitoring and Computing in which Dr Vikrant Sharma, along with Dr Steven J. Barker, Dr William C. Wilson, and colleagues at Masimo performed a focused analysis of previously published data to evaluate the impact of low perfusion on the performance of Masimo SET pulse oximetry across a variety of skin pigmentations. The analysis demonstrated that Masimo RD SET sensors accurately measured oxygen saturation (SpO2) for both Black and White subjects when perfusion index (Pi) was normal and when Pi was low – adding to the body of evidence that Masimo SET pulse oximetry delivers accurate values across the skin tone range, with no clinically significant difference in accuracy or bias, even in challenging conditions. In a study published in 2023, Drs. Barker and Wilson analyzed Masimo laboratory data obtained from self-identified Black and White volunteer subjects to evaluate differences in Masimo pulse oximetry accuracy and bias on the basis of skin tone. To do so, they reviewed more than 7,000 paired data samples (collected between 2015 and 2021) from 75 subjects (39 Black and 36 White) and found no clinically significant difference in accuracy or bias. For this newly published study, noting that low peripheral perfusion is a “recognized confounder of conventional pulse oximetry” and in light of concerns that low perfusion combined with dark skin pigmentation might decrease pulse oximetry’s accuracy, the investigators sought to determine whether accuracy on Black or White subjects was impacted by a subject’s perfusion index (Pi) with Masimo SET pulse oximetry. To that end, they abstracted Pi values from their dataset, and divided them into “low perfusion” (Pi ≤ 1) and “normal perfusion” (Pi > 1) groups. They then performed statistical analyses to determine bias (the mean difference between SpO2 and arterial oxygen saturation [SaO2]), precision (the standard deviation of the difference), and accuracy (root-mean-square error, or ARMS*). The researchers found that in the normal perfusion group, comparing SpO2 to SaO2 values, there was overall bias and precision of +0.18% ± 1.34%, with accuracy of 1.37% ARMS. For the subset of Black subjects, there was bias and precision of -0.26% ± 1.37%, and for White subjects, -0.12% ± 1.31%. In the low perfusion group, there was overall bias and precision of 0.48% ± 1.59%, with accuracy of 1.64% ARMS. For Black subjects, bias and precision were 0.19% ± 1.53%, and for White subjects, 0.91% ± 1.57%. Based on their analysis, the authors concluded, “Masimo SET pulse oximeters with RD SET sensors are accurate for individuals of both Black and White races when Pi is normal, as well as during conditions when Pi is low. The ARMS for all conditions studied is well within FDA standards. This study was conducted in healthy volunteers during well-controlled laboratory desaturations, and results could vary under certain challenging clinical conditions.” However, the authors noted that controlling conditions in the laboratory setting helps “minimize confounders that are present in clinical scenarios, allowing for greater focus on the topics of skin tone and Pi. Indeed, abnormal hemoglobin species (e.g., carboxyhemoglobin and methemoglobin) [known clinical SpO2 confounders] were measured and reported in the earlier paper by Barker and Wilson, and the values were similar (statistically the same) between Black and White groups. Also, one can only ethically conduct desaturation studies using healthy volunteer subjects in a safe setting.”

Device Maker Welcomes New CEO

FEB 6 2024

React Health, a leading US sleep, respiratory and cardio-pulmonary device manufacturer, distributor, and diagnostic services provider, is excited to announce the appointment of Bill Shoop as its Chief Executive Officer. Bill brings two decades of invaluable experience in the healthcare industry, with his most recent role being Vice President and General Manager of ResMed North America. In his previous capacity at ResMed, Shoop demonstrated his exceptional leadership skills and played a pivotal role in the company’s success. Now as React Health’s CEO, he is poised to bring his wealth of knowledge and expertise to lead the company to even greater success. Bill shared his enthusiasm for the new role, saying “I am extremely excited about the opportunity to join this experienced and talented team. I believe React Health is very well positioned to help the industry and continue to advance our mission of delivering innovative solutions that positively impact patients’ lives and the people that care for them.” React Health is confident that Bill’s strategic vision and leadership will contribute to the company’s continued growth and success. “Bill is a proven executive with a successful record of building strong and diverse teams. He is a passionate leader who delivers results”, said Sean Heyniger, React Health Board Member. Bill Shoop officially assumed his role as CEO of React Health effective February 1, 2024.

Conference Comes Back to America

FEB 2 2024

ECO PHYSICS, INC. will exhibit at the International Association of Breath Research’s (IABR) International Conference for Breath Research. This year the show will take place in Indianapolis, Indiana-the heartland of America. This is the first time in twelve years the show will be held in the USA, from June 3-6, 2024. The International Congress for Breath Research represents an opportunity for experts to learn and exchange the latest breakthroughs and emerging topics on breath research with peers around the world. More than 150 guests from academics, basic sciences, medicine, industrial companies, and laboratories are expected to attend. ECO PHYSICS, INC. will be presenting and exhibiting the Analyzer CLD 88 Series for exhaled nitric oxide research measurements. ECO PHYSICS, INC. offers a broad range of nitric oxide (NOx) analyzers for medical research & indoor, ambient, tropospheric, and stratospheric monitoring. The principle of chemiluminescence detection (CLD) is an extremely selective method for measuring NO precisely, with high linearity over a wide concentration range and with remarkably high reproducibility. ECO PHYSICS, INC. is the sole North American distributor of ECO PHYSICS AG and ECO MEDICS AG nitric oxide measurement devices.

Five Bold Predictions for Long COVID in 2024

JAN 30 2024

#1: We'll gain a better understanding of each long COVID phenotype This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms. Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell. Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a "one-size-fits-all disease." #2: Monoclonal antibodies may change the game We're starting to have a better understanding that what's been called "viral persistence" as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it's still fighting acute COVID-19. Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. "Remission occurred despite dissimilar past histories, sex, age, and illness duration," wrote the study authors. Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world. #3: Paxlovid could prove effective for long COVID The US Food and Drug Administration granted approval for Paxlovid for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that's been used in patients with HIV and helps boost levels of antivirals in the body. In a large-scale trial headed up by Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID. Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can't clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It's a different mechanism with the same end goal. It's been a controversial treatment because it's life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment. #4: Anti-inflammatories like metformin could prove useful Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA. The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin. Still, other anti-inflammatories that could work don't have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient's risk for long COVID up to 40% when the drug was taken during the acute stage. Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications. #5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus. Researchers found that the reduction in serotonin levels was partially caused by the body's inability to absorb tryptophan, an amino acid that's a precursor to serotonin. Overactivated blood platelets may also have played a role. If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.

Philips' US Sales Of Sleep Apnea Devices Face Years-long Halt After FDA Deal

JAN 30 2024

Dutch health technology company Philips will not sell new devices to treat sleep apnea in the US in the coming years as it works to comply with a settlement with the Food and Drug Administration (FDA) announced. The agreement followed the recall of millions of breathing devices and ventilators used to treat sleep apnea in 2021 because of concerns that foam used to reduce noise from the devices could degrade and become toxic, carrying potential cancer risks. Philips said it had reached what is known as a consent decree that spells out the improvements it needs to make at its Respironics plants in the US. Until the conditions are met, no new Respironics devices will be sold in the US, the company said. Philips shares were down in Amsterdam, after news of the agreement, which ING analyst Marc Hesselink said was “very punitive.” “We believe it will be very difficult for Philips to recover its US Respironics market position,” Hesselink said in a note. Citi analyst Mathieu Chevrier said he had previously assumed Philips would return to the U.S. market from July, but Monday’s announcement delays the timeline, and is likely a positive for rival ResMed. Shares of ResMed rose nearly 2% in early US trading. The decree is being finalized and will be submitted to the relevant U.S. court for approval. It was not clear how long that would take. CEO Roy Jakobs declined to give details on the conditions that Philips will have to meet, but as a general indication said it on average takes between five and seven years to comply with consent decrees in the medical equipment industry. Philips said the costs of the agreement led to a provision of 363 million euros ($393.5 million) in the fourth quarter of last year, and were expected to be about 1% of total revenues in 2024.

High and Low Body Mass Indices Promote Respiratory Symptoms

JAN 30 2024

Individuals with either high or low body mass index (BMI) showed an increased risk for respiratory symptoms and diseases than those with BMI in the normal range. The researchers reviewed data from the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2012; the study population included 12,719 adults older than 40 years with data on respiratory symptoms; 51% were female, and 53.3% were non-Hispanic White individuals. The study sought to assess the correlation between BMI and respiratory symptoms (cough, wheezing, and dyspnea), chronic obstructive pulmonary disease (COPD), and asthma in unadjusted and adjusted models based on sex, race, marital status, poverty-income ratio (PIR), education level, and smoking status. In a logistic regression and curve fitting analysis, BMI showed a U-shaped relationship with respiratory symptoms, asthma, and COPD, with increased risk in individuals with high or low BMI than those with BMIs in the middle quartiles. In a stratified analysis by race, the risk for cough was significantly higher among non-Hispanic Black individuals than other races (P < .0001), and a higher BMI was associated with an increased risk for COPD in non-Hispanic Black individuals (odds ratio, 1.053; P < .0001). The researchers found no significant impact of biological sex on the relationship between BMI and respiratory symptoms, COPD, or asthma. The results support previous studies showing that a BMI that is too low can be detrimental to health. "These results suggest that the risk of small airway obstruction in underweight individuals deserves more attention and that excessive wasting may also affect the prognosis of patients with COPD," the researchers wrote. The lead author on the study was Yuefeng Sun of Shandong University of Traditional Chinese Medicine, Jinan, China.

Masimo Announces Reinstatement of Import Ban on Infringing Apple Watches

JAN 18 2024

Masimo, a global leader in innovative noninvasive monitoring technologies, welcomes the Federal Circuit’s ruling to lift the temporary stay on the import ban of certain Apple Watch models. This decision reinstates the US International Trade Commission’s import ban and cease and desist order on Apple watches that were found to infringe Masimo’s patented pulse oximetry technology. “The Federal Circuit's decision to lift the temporary stay is a victory for the integrity of the American patent system and the safety of people relying on pulse oximetry,” said Joe Kiani, Founder and CEO of Masimo. “It affirms that even the largest and most powerful companies must respect the intellectual rights of American inventors and must deal with the consequences when they are caught infringing others’ patents.” Masimo has previously made available a study showing that Apple Watch’s pulse oximetry missed over 90% of potentially life-threatening events. The Apple Watch pulse oximeter was not cleared by the United States Food and Drug Administration for medical use. On the other hand, the Masimo W1 health watch was recently cleared by the FDA for its indicated medical uses, including continuous pulse oximetry. Masimo’s pulse oximetry technology is used on over 200 million patients in hospitals a year and has been proven to help save babies’ eyesight in the neonatal ICU, detect critical congenital heart defects in newborns, and save the lives of patients in post-surgical wards who are taking opioids.

Monoclonal Antibodies: A New Treatment for Long COVID?

JAN 2 2024

A treatment used to treat acute COVID-19 infection has also been found to be effective against long COVID, a new small study has found. The research, which assessed the benefits of monoclonal antibodies, suggests relief may finally be ahead for millions of Americans with long COVID for whom treatment has remained elusive. The study, published in the American Journal of Emergency Medicine, found three Florida patients with long COVID made complete — and sudden — recoveries after they were given the monoclonal antibody cocktail casirivimab/imdevimab (Regeneron). "We were struck by how rapid and complete the remissions were," said study coauthor Paul Pepe, MD, MPH, a professor of management, policy and community health at the School of Public Health at the University of Texas Health Sciences Center. "We found that no matter how long the patients were sick for — whether it was 5, 8, or 18 months — within 5 days, they appeared to be completely cured." All three patients had been initially infected with COVID-19 early in the pandemic, in 2020 or the first half of 2021. They were given Regeneron either after a reinfection or exposure to COVID-19, as a preventative, at state-run COVID clinics in Florida. "In each case, the infusions were given to help prevent their long COVID from worsening," said Pepe. The researchers collected medical histories for all three patients, asking about symptoms such as physical fatigue, exercise intolerance, chest pain, heart palpitations, shortness of breath, cognitive fatigue, and memory problems. They asked patients to rate symptoms pre-COVID (baseline), during the long COVID phase, post-vaccine, and finally a week after their monoclonal antibody treatment. They also interviewed family members. They found that across the board, symptoms improved significantly and often completely vanished. Their loved ones corroborated these reports as well. When one patient was exposed to COVID-19 in October 2021, her doctor suggested Regeneron as a preventative. She agreed to it. "I was terrified that a second round would leave me permanently disabled and stuck in bed for the rest of my life," she said. About 4 days after her monoclonal antibody treatment, she noticed that some of the brain fog that had persisted after COVID was lifting. "By day 5, it felt almost like a heavy-weighted blanket had been lifted off of me," she recalled. "I was able to take my dog for a walk and go to the grocery store. It felt like I had gone from 0 to 100. As quickly as I went downhill, I quickly went back up."

Beetroot Juice Improves Fitness and Function in Patients With COPD

JAN 2 2024

Daily consumption of beetroot juice significantly improved blood pressure, vascular function, and exercise capacity in adults with chronic obstructive pulmonary disease (COPD) over 12 weeks compared with a placebo drink. The lead author on the study was Ali M. Alasmari, MD, of Imperial College, London. The findings were published online ahead of print in European Respiratory Journal in December 2023. Dietary nitrate has been associated with improved cardiovascular risk profiles, but the impact of nitrate supplementation in patients with COPD who have increased risk for cardiovascular disease has not been well studied. The researchers randomly assigned 81 adults with COPD and a systolic blood pressure (SBP) ≥ 130 mm Hg to nitrate-rich beetroot juice (NR-BRJ) — 70 mL of beetroot juice containing 400 mg of nitrate — or a placebo drink with no nitrate daily for 12 weeks. The primary outcome was a change in SBP based on home measurements; secondary outcomes were a change in 6-minute walking distance and changes in endothelial function based on the reactive hyperemia index (RHI) and augmentation index corrected for heart rate at 75 beats/min (AIx75). NR-BRJ consumption was significantly associated with decreased SBP compared with placebo, with a difference of -4.5 mmHg (P < .001). The NR-BRJ group also showed significant improvement compared with the placebo group in the secondary outcomes of 6-minute walking distance (average increase of 30 meters; P < .001) and endothelial function based on RHI (increase of 0.34; P = .03) and AIx75 (-7.61%; P = .026). Plasma nitric oxide (NOx) and fractional exhaled nitric oxide (FeNO) data were available for 24 patients in the NR-BRJ group and 20 in the placebo group; plasma NOx increased from baseline in the treatment group, but not the placebo group, and the increase in FeNO was significantly greater from baseline in the treatment group compared with the placebo group. No significant changes were noted between the groups in platelet aggregation and P-selectin expression. "In this study, the substantial increases in plasma NOx concentration after NR-BRJ were associated with SBP reduction, providing further evidence that nitrate/nitrite reduction to NO most likely underlies the BP-lowering effects seen with BRJ consumption," the researchers wrote.

New Study Finds Significant Correlation Between Masimo ORi and Arterial Partial Pressure of Oxygen During One-Lung Ventilation

DEC 13 2023

Masimo announced the findings of a retrospective study published in the Journal of Anesthesia in which Dr Yu Jeong Bang and colleagues at the Samsung Medical Center, Sungkyunkwan University School of Medicine, in Seoul, South Korea, investigated the association of Masimo ORi and the arterial partial pressure of oxygen (PaO2) in 554 patients who underwent non-cardiac thoracic surgery during one-lung ventilation (OLV), making this study the largest to date on ORi. The researchers found that ORi values “were significantly correlated with PaO2 measured simultaneously” and that ORi “could provide useful information on arterial oxygenation even during one-lung ventilation.” Noninvasive, continuous Masimo ORi provides continuous, real-time insight into the oxygenation of hemoglobin in the moderate hyperoxic range (PaO2 > 100 and ≤ 250 mmHg) to be used alongside arterial blood gas analyses, which have the drawbacks of being invasive, intermittent, and delayed. ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of the patient oxygenation beyond SpO2 under supplemental oxygen. By convention, SpO2 is limited to an upper limit of 100%, but oxygenation is not limited and can rise into hyperoxia (higher than normal oxygenation state) when supplemental oxygen is administered. ORi provides clinicians with additional visibility, as a complement to SpO2 monitoring with Masimo SET pulse oximetry, into when oxygenation is increased into, or decreased out of, moderate hyperoxia, in real time. Noting the importance of striving to prevent hyperoxemia and hypoxemia especially during surgery requiring OLV, because of the risk of pulmonary complications, the researchers sought to evaluate a noninvasive, continuous method of predicting imminent over- or under-oxygenation to overcome the drawbacks of invasive blood gas analysis alone, using Masimo ORi. To evaluate ORi’s performance, they analyzed data collected from 554 patients who underwent non-cardiac elective thoracic surgery requiring OLV between January 1 and December 31, 2022 at a tertiary hospital in South Korea. During anesthesia, ORi was monitored using Masimo RD rainbow SET® Pulse CO-Oximetry sensors, and blood gas analysis was performed 15 minutes after OLV was initiated. The researchers’ primary endpoint was the association between simultaneous ORi and PaO2 values. They also sought to identify risk factors for PaO2 < 150 mmHg, based on their clinical experience that most patients with PaO2 > 150 mmHg in this scenario rarely show hypoxemia. The researchers found a linear correlation between ORi and PaO2 measured simultaneously. Using linear regression analysis, they found there was a statistically significant positive relationship between ORi and PaO2 measured 15 minutes after OLV initiation (r2 = 0.5752, p < 0.001). Using receiver-operated curve (ROC) analysis, they identified an optimal cut-off ORi value of 0.27 to detect PaO2 ≥ 150 mmHg during OLV (area under the ROC curve of 0.96, 95% confidence interval of 0.94 – 0.98, sensitivity 0.909, specificity 0.932). Of the 11 potential predictors for PaO2 < 150 mmHg identified by the researchers, ORi was highly predictive (odds ratio 0.001, p < 0.001). The researchers concluded, “ORi values during one-lung ventilation were significantly correlated with PaO2 measured simultaneously. Therefore, the ORi monitor can provide useful information for estimating the PaO2 value even during one-lung ventilation.” In the US, ORi has been granted a De Novo by the 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.

Great Place to Work

DEC 5 2023

DALE MEDICAL PRODUCTS, INC. has been named one of the Top Places to Work in Massachusetts in the 15th annual employee-based survey project from The Boston Globe. Top Places to Work recognizes the most admired workplaces in the state voted on by the people who know them best—their employees. The survey measures employee opinions about their company’s direction, execution, connection, management, work, pay and benefits, and engagement. The employers are placed into one of four groups: small, with 50 to 99 employees; medium, with 100 to 249 workers; large, with 250 to 999; and largest, with 1,000 or more. DALE MEDICAL PRODUCTS, INC. was ranked 35 in the SMALL BUSINESS category. "We are very proud of this accolade and recognition. It is a rewarding tribute to our legacy in the patient care market we serve, and our strong culture driven by our employee owners." says Robert Simpson, Chief Executive Officer of Dale. “The best employers are always striving to put their people first, whether they’re honoring small individual accomplishments or adjusting company-wide policies to become more inclusive.” said Katie Johnston, the Globe’s Top Places to Work editor. The rankings in Top Places to Work are based on confidential survey information collected by Energage (formerly WorkplaceDynamics), an independent company specializing in employee engagement and retention, from more than 137K individuals at 347 Massachusetts organizations. The winners are constantly working to improve their workplaces, from investigating how artificial intelligence can assist workers, not replace them, to helping workers get to know each other in an increasingly hybrid world.

Mobile Application is Redefining Ventilation Training

DEC 5 2023

Hamilton Medical, a renowned name in the field of medical innovation, introduced its latest cutting-edge solution for healthcare professionals, the VenTrainer App. Specifically designed for clinicians working with mechanical ventilators in critical care and emergency medical services, the VenTrainer App promises a transformative approach to training and skills development. The VenTrainer App provides an immersive and easily accessible learning experience. Users can explore Hamilton Medical's ventilators and their features through an interactive 360° animation, offering a comprehensive understanding of these life-saving devices. The app replicates the entire ventilator user interface on mobile devices or computers, allowing clinicians to familiarize themselves with ventilator functions, graphics, alarm settings, parameters, and tools. Thanks to a physiologic patient model, users can monitor how their ventilation strategy impacts patient outcomes in real-time. The adjustable patient model encompasses various lung conditions, including pre-configured patient scenarios like ARDS with recruitable properties. The app even supports ABG analysis to fine-tune ventilation strategies. By seeing direct outcomes from their decisions, healthcare professionals can develop and refine their skills and make informed decisions. The VenTrainer App offers healthcare professionals the unique opportunity to transform their mobile devices or computers into powerful ventilator simulators. By providing a complete user interface experience, clinicians can gain hands-on knowledge in a safe and controlled environment. Available for free for iOS, Android, and Windows devices, the VenTrainer App is a cost-effective and easily accessible solution for professionals seeking to enhance their ventilation knowledge. For educators teaching mechanical ventilation, the VenTrainer App is a versatile tool to create an immersive and cost-effective learning environment. Students can enjoy hands-on experience, following along as educators demonstrate and explain ventilation techniques directly on their devices. No additional equipment is needed, making it a user- friendly solution for modern education.

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 &amp; 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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