US Plans to Speed Insurance Coverage for Medical Devices April 24, 2026 By Annika Inampudi Breakthrough medical devices will get faster insurance coverage in the US under a new government program that coordinates coverage with...
FDA Bans Electrical Shock Medical Device in Rare Regulatory Action March 5, 2020 The U.S. Food and Drug Administration on Wednesday banned electrical stimulation devices (ESDs) used in curbing self-injurious or aggressive behavior,...
FDA Says 3 Deaths Linked to Recalled Heart Device July 2, 2019 The U.S. Food and Drug Administration said on Monday three deaths had been reported related to Edwards Lifesciences Corp.’s recall...
FDA Vows Overhaul of Medical Device Approval System November 29, 2018 By Matthew Perrone U.S. health officials said this week they plan to overhaul the nation’s decades-old system for approving most medical devices, which...
Bayer to Discontinue Sales of Essure Birth Control Device as U.S. Lawsuits Mount July 23, 2018 By Matthew Perrone and Lindsey Tanner The maker of a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators said...
How to Make Implants, Pacemakers and Other Medical Devices Safer April 20, 2018 By Matthew Perrone U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized...
FDA Cites Hospitals for Under-Reporting of Injuries from Medical Devices October 25, 2016 By Toni Clarke The U.S. Food and Drug Administration is seeking to improve hospital reporting of injuries and deaths associated with medical devices...
Report Cites Failure to Prevent Unsafe Medical Devices That Spread Superbugs January 18, 2016 By John Tozzi America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs,...