We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Yet another headache has arisen for Philips over the recall of its continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices in the form of a class-action lawsuit filed by durable medical equipment (DME) device suppliers. Read More
The FDA has handed Ray Vision an 11-observation Form 483 after an inspection of the ophthalmic equipment company’s Lake Forest, Calif., facility identified various documentation and other lapses. Read More
In clinical trials, 96 percent of participants were able to sleep in their preferred sleeping position and most users rated the mask as “comfortable” or “very comfortable.” Read More
The Breakthrough Device designation means that the FDA will expedite its review because of the device’s potential to aid in the treatment or diagnosis of a life-threatening or debilitating disease or condition. Read More
The medical device industry finds the FDA’s draft guidance on reporting medical device and diagnostic shortages during public health emergencies (PHEs) too far-reaching and too burdensome. Read More