FDA Ends Summary Medical Device Reporting
WASHINGTON, D.C. — The United States Food and Drug Administration (FDA) finally put an end to summary medical device reporting. According to U.S. Recall News, FDA rules allowed medical device manufacturers to summarily report medical device malfunctions and defects that caused injuries or deaths to patients. The practice known as … [Read more...]
New Medtronic Endeavor Stent Faces Doubts
Medtronic’s new drug coated stent, Endeavor, still faces some serious questions about its effectiveness, after a long-anticipated study showed that the device had only mixed success in meeting some performance goals. The new data was released just days before Endeavor undergoes a regulatory review, the outcome of which could help … [Read more...]
Essure Lawsuits Continue to Be Filed
Bayer Faces Thousands of Essure Injury Lawsuits Product liability lawsuits continue to be filed against Bayer alleging injuries from Essure, the female sterilization device. In the United States, roughly 3,700 lawsuits have been filed. Litigation has also begun in Canada. The U.S. Food and Drug Administration (FDA) reports over … [Read more...]
New Medical Device Guidance Finalized
FDA New Medical Device Guidance Medical device guidance is meant to provide the healthcare community and patients with prompt information on changes to medical devices. Consumers will see more rapid notifications regarding medical device risks and potential risks following guidance recently finalized by the U.S. Food and Drug … [Read more...]
MassTorts in the Spotlight
Medical Device Associated Injuries, Deaths And Malfunction. Each year, the FDA receives an excess amount of medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device reportage is one among the postmarket tools the bureau uses to watch device performance, discover potential … [Read more...]
Improved Reporting on Medical Device Injuries Deaths
Medical Device Improved Reporting. The U.S. Food and Drug Administration (FDA) is seeking to improve hospital reporting of medical device injuries after inspections last year at 17 hospitals exposed numerous device safety issues. During last December's FDA inspections, it was revealed there was a limited or no reporting of … [Read more...]
Better Reporting for Medical Device Injuries
Medical Device Better Reporting Urged. In light of medical devices that have raised concerns in recent years, regulators and lawmakers are both looking to improve the way medical device injuries and deaths are reported. Specifically, there has been criticism over the delayed awareness of power morcellators, devices that can … [Read more...]
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