The Magazine for Sleep Professionals
Sunday, August 30, 2026
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Puritan Bennett 980 Series Ventilator Model Numbers: See Recall Database Entries Distribution Dates: February 23, 2017 to April 4, 2020 […]
A paper published online in the Annals of the American Thoracic Society presents research discussing how new air quality standards recommended by the American Thoracic Society have the potential to prevent more illness and death than standards adopted by the U.S. Environmental Protection Agency (EPA). This study is part of the […]
Sound Life Sciences, a pioneer in contactless respiratory monitoring with its proprietary sonar software for consumer smart devices, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The privately-held telehealth startup’s smartphone or smartspeaker app produces inaudible ultrasonic sonar pulses to detect reflections caused […]
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, developed and commercialized by UK-based medical device company Acurable, builds on more than ten […]
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company De Novo clearance for the Hemolung Respiratory Assist System. The Hemolung System is the first and only […]
GE Healthcare announced it has received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on […]
The U.S. Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. “Ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices […]
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Circadiance’s SleepWeaver masks are now on the SleepGlad formulary, a mask selection tool driven by artificial intelligence to help PAP patients find the perfect fit on the first try. This partnership puts Circadiance’s SleepWeaver PAP masks onto the SleepGlad mask formulary. SleepGlad is the world’s first remote, 3D-scanning PAP/NIV mask fitter, requiring no […]
