The Magazine for Sleep Professionals
Thursday, October 8, 2026
LivaNova PLC has announced the first patient implanted in the investigational device exemption (IDE) clinical study, “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” (OSPREY). The randomized controlled trial (RCT) seeks to demonstrate the safety and effectiveness of the LivaNova aura6000™ System, an implantable hypoglossal neurostimulator intended to treat adult patients with […]
WatchPAT® with SleePATh® is a digital solution for clinicians which integrates automated subjective patient data with the WatchPAT® ONE home sleep study results for enhanced diagnosis, data management and analysis. It simplifies the patient journey, streamlines the clinical experience and enhances the diagnosis. It combines pre and post sleep study […]
In December 2021, imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a potential issue with bellavista™ 1000 and 1000e ventilators that […]
The following email was sent to users on February 3, 2022. We’re writing to you with two important updates about your recalled Philips device.* As always, thank you for your continued patience as we work hard to ensure as many patients as possible can continue safely with their therapy. Our […]
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 […]
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 […]
