medical device safety News

FDA Medical Panel Opposes Restrictions on Breast Implants at This Time

Government medical advisers said this week it’s too soon to ban a type of breast implant that has recently been linked to a rare form of cancer, saying more information is needed to understand the problem. The Food and Drug …

Olympus to Pay $85 Million for Failing to Report Medical Device Contamination Risks

An Olympus Corp. subsidiary pleaded guilty on Monday and agreed to pay $85 million to resolve charges that it failed to file reports with U.S. regulators regarding infections connected to its duodenoscopes while continuing to sell the medical devices used …

FDA Vows Overhaul of Medical Device Approval System

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 …

Bayer to Discontinue Sales of Essure Birth Control Device as U.S. Lawsuits Mount

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 …

How to Make Implants, Pacemakers and Other Medical Devices Safer

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 …

FDA Cites Hospitals for Under-Reporting of Injuries from Medical Devices

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 …

Liability Insurer Accuses Surgical Robot Maker of Hiding Injury Claims

It’s health insurers’ cardinal rule: disclose pre-existing conditions. Now comes a case in which that familiar decree involves not a patient, but rather a $1.5 million surgical robot known as the da Vinci system. Two insurance companies say da Vinci’s …

Report Cites Failure to Prevent Unsafe Medical Devices That Spread Superbugs

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, …

Travelers Adds Endorsements to MedFirst Policy for Medical Technology Industry

To fill in the potential coverage gaps not covered by a traditional general liability policy, Travelers has introduced MedFirst Plus, four new coverage endorsements to its MedFirst policy for the medical technology and device industry. The new Travelers MedFirst Plus …

FDA Plans IDs to Track Medical Device Safety

Medical devices like hip implants and heart defibrillators will soon join the ranks of cars and toasters. The U.S. Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code …