Edwards Lifesciences recalls its EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms due to the potential for fluids to leak into the AC power outlet...
Federal Register notice: FDA determines that the regulatory review period for Edwards Lifesciences Edwards Intuity Elite Aortic Valve is 1,508 days.
Federal Register notice: FDA makes available a final guidance entitled Section 503A Bulks List Final Rule Questions and Answers.
FDA clears a CD Diagnostics de novo marketing request for the Synovasure Lateral Flow Test Kit to serve as an aid for detecting periprosthetic joint i...
Researchers call for a more standardized approach to research real-world evidence and its best uses.
Former FDA commissioner Scott Gottlieb returns to the venture capital firm he was at just before being appointed to the agencys top post in 2017 New ...
Federal Register notice: FDA announces an amendment to a 4/24 Federal Register notice about a 5/30-31 General and Plastic Surgery Devices Panel meetin...
The Senate HELP Committee releases a draft of bipartisan legislation with more than 30 specific provisions for reducing health care costs, including s...