The expanded 510 (k) clearance is publicly available in the FDA's 510 (k) Premarket Notification database under device number K253939.

Company Transitions from Infrastructure Buildout to Active Market Execution as Expanded 510(k) Review Enters Final ...

Certain Philips Respironics DreamStation breathing devices, commonly used for treating sleep apnea, may deliver the incorrect prescription or no therapy at all, the FDA warned in a recall announcement ...

Attention! Another new term has entered the TikTok lexicon, and you’re about to see it everywhere. If you’ve spent any time on the app within the past week, you might have noticed people talking about ...

Bringing notable enhancements over its predecessor, the Lofree Flow 2 is an excellent mechanical keyboard built with care and quality. PC Gamer's got your back Our experienced team dedicates many ...

Philips Respironics has updated use instructions for three bi-level positive airway pressure machines, according to a recall statement posted by the US FDA. The recall does not include removal of the ...

In a pooled analysis of three randomized trials, CPAP had overall null cardiovascular effects in patients with obstructive sleep apnea and cardiovascular disease. However, CPAP leaned toward benefit ...

Thinking about using a CPAP machine to quell sleep apnea? It's not necessarily a good idea for everyone, a new evidence review argues. This common treatment for sleep apnea might increase some folks' ...

As a Behavioral Sleep Medicine Specialist, I see firsthand how challenging it is for many patients to acclimate to CPAP (continuous positive airway pressure) machines. In addition to being familiar ...

Michelle Spear does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond ...

Every night, millions of people stop breathing without knowing it. Not once, but sometimes hundreds of times. Their remedy? A mask, a hum and the steady whisper of pressurized air. It's not glamorous, ...