The Philips CPAP Nightmare Exposes Shortcomings in Medical Device Regulation

February 6, 2024

picture of the U.S. Food and Drug Administration sign

(STAT News) – America’s outdated approach to medical device oversight starts with limited testing prior to FDA authorization for the vast majority of marketed devices and ends with patchwork monitoring of patient safety. The tale of Philips Respironics — which has now grown to encompass over 100,000 reports of injuries and hundreds of deaths — illustrates many of these shortcomings. (Read More)