Reps. Mike Fitzpatrick, R-Pa., and cosponsor Louise Slaughter, D-N.Y., introduced medical device reform bills that would let courts consider product liability suits for PMA-approved devices and require physicians to report to FDA adverse events involving medtech products.
Stimulated by grassroots campaigns by patient advocates who say they were harmed by Bayer HealthCare LLC's Essure sterilization product or gynecologists' use of alleged cancer-spreading power morcellators to clear uterine fibroids, Reps. Mike Fitzpatrick, R-Pa., and Louise Slaughter, D-N.Y., introduced two bills in the House on June 8.
"While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences on patients," commented...
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.
Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.
