The U.S. FDA approved a new feature for detecting obstructive sleep apnea (OSA) on the Samsung Galaxy watch and smartphone, Samsung Electronics Co. Ltd. said on Feb. 10.
Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.
Dentists at Melbourne, Australia-based 3DSG Pty Ltd. are seeking patent protection for a plug and socket set for use in a mandibular advancement splint set for treating snoring or sleep apnea.
Resmed Inc. has acquired Somnoware Inc., a privately held developer of respiratory care diagnostics software, for an undisclosed price. The deal is Resmed’s third software acquisition in the past year, having snapped up German software-as-a-service (SaaS) maker Medifox Dan GmbH for $1 billion in June 2022 and Mementor GmbH last August.
Wesper Inc., a longitudinal and wireless clinical-grade sleep testing platform, showed ‘exceptional accuracy’ in a head-to-head comparison with polysomnography in a study published in The Journal of Clinical Sleep Medicine. The wireless, longitudinal sleep testing platform had a breathtaking 95% correlation with the cumbersome gold standard test for sleep apnea.
BMC Medical Co. Ltd. raised ¥1.918 billion (US$264 million) on the Shenzhen Stock Exchange. Its shares opened on Nov. 1 at ¥230 per share, surged more than 140% in the middle of the day and closed at ¥290.
Orexia Therapeutics Ltd. has divulged 2-(3-ethynylbenzyl)-substituted heterocycle derivatives acting as orexin OX2 receptor agonists reported to be useful for the treatment of narcolepsy, hypersomnia, insomnia and sleep apnea.
Just days after taking the helm of Royal Philips NV, CEO Roy Jakobs told shareholders that the company plans to “immediately reduce our workforce by around 4,000 roles globally” as a result of multiple challenges that contributed to poorer than expected third quarter results. The company posted a net loss for the quarter, missing consensus, which it attributed to continuing supply chain issues and the deteriorating economic environment.
For a company that dominates the market for devices designed to improve breathing during sleep, Royal Philips NV has had the devil of time catching its own breath over the last 15 months as it has issued wave after wave of recalls.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.