The Magazine for Sleep Professionals
Sunday, August 30, 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 […]
Masimo marks its 33rd anniversary by announcing the limited market release of the W1™ health watch for consumers. The first of its kind, the Masimo W1 offers accurate, continuous measurements and actionable health insights – from the leader in hospital pulse oximetry – in a personal, discreet, lifestyle-friendly wrist-worn wearable. […]
The FDA announced its decision to “prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars.” In response, the American Thoracic Society issued the following statement: “The ATS strongly supports the FDA proposed action to remove menthol-flavored cigarettes and flavored cigars from the U.S. marketplace,” said Hasmeena Kathuria, MD, ATS Tobacco […]
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 […]
ŌURA, the company behind the smart ring that delivers personalized health data, insights, and daily guidance, today announced it has raised capital at a $2.55 billion valuation, less than a month after reaching the milestone of selling 1,000,000 Oura Rings. Demand for the Oura Ring Gen3 has been significant, resulting […]
CAIRE’s premier portable oxygen concentrator, the FreeStyle® Comfort®, outperformed other market-leading devices in a recent study designed to assess the effectiveness of these devices in delivering oxygen to patients. The study, “Comparison of portable oxygen concentrators using a COPD patient simulation model,” was conducted by Rachel Culbreth, Ph.D., MPH, RRT; Robert […]
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 […]
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 […]
