The Magazine for Sleep Professionals
Thursday, September 24, 2026
The FDA’s Center for Devices and Radiological Health is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices […]
Fisher & Paykel Healthcare has announced the United States launch of F&P Evora™ Full, a compact full-face mask for obstructive sleep apnea (OSA) treatment. The mask has received FDA 510(k) clearance, paving the way for its sale into the United States following its launch in Australia, New Zealand, Europe and […]
Fisher & Paykel Healthcare Corporation Limited provided revenue guidance for the financial year ending 31 March 2022. At current exchange rates, the company expects full year operating revenue for the 2022 financial year to be in the range of $1.675 billion to $1.70 billion. Managing Director and Chief Executive Officer […]
On March 10th, the U.S. Food and Drug Administration issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the […]
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 […]
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 […]
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 […]
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 […]
Nyxoah SA has announced that the U.S. Food and Drug Administration has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA’s Breakthrough Designation Program was created […]
Positioned at the forefront of helping people with obstructive sleep apnea (OSA) improve their health and quality of life, AR Medical Technologies launches MaskFit AR. Powered by artificial intelligence and machine learning, MaskFit AR overcomes a 30-year problem of improper patient mask fitment for people who use CPAP or BiPAPTM to […]
