The U.S. Food and Drug Administration on Wednesday banned electrical stimulation devices (ESDs) used in curbing self-injurious or aggressive behavior, citing substantial risks of illness or injury to patients. The agency’s final decision comes after the devices were found to …
The U.S. Food and Drug Administration said on Monday three deaths had been reported related to Edwards Lifesciences Corp.’s recall of some of its heart devices. The agency said the company’s voluntary recall of its IntraClude intra-aortic occlusion device in …
U.S. health officials said this week they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical instruments. The Food and …
The maker of a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators said Friday that it will stop selling the device in the U.S., the only country where it remains available. Bayer said …
U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments. The plan from the Food and Drug …
The U.S. Food and Drug Administration is seeking to improve hospital reporting of injuries and deaths associated with medical devices after inspections at 17 hospitals revealed widespread under-reporting of such events. The FDA initiated the inspections following high-profile safety scandals …
America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released today. The report, from Senator Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, …
