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Advisers to the U.S. Food and Drug Administration on Tuesday backed an approval for Abbott Laboratories' heart valve repair device that is designed for patients who are at risk of complications or ...
(Reuters) -Abbott Laboratories said on Tuesday the U.S. FDA has approved its heart valve repair device for patients with a potentially fatal heart disease, just months after rival Edwards ...
The Trifecta (TM) Valve. (Photo: St. Jude Medical, Inc.) Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta ...
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology) , who had two faces, one that could see in the past and one that could see in the future.
St Jude Medical's Portico Transcatheter aortic valve received European CE mark approval in December 2013. The valve is repositionable before release to ensure accurate placement helping to improve patient outcomes. [12] Edwards' Sapien aortic valve is made from bovine pericardial tissue and is implanted via a catheter-based delivery system. It ...
In 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH). Former leaders of CDRH [15] Jeffrey Shuren, M.D., J.D., CDRH Director 2009 – 2024; Daniel Schultz M.D., CDRH Director 2004 – 2009
An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary.
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