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TransMedics Heart Transplant Tool Lands FDA Panel Date After 6-Month Delay

 
• By Elizabeth Orr

The US agency’s circulatory system devices panel will take up the company’s heart transplant tool in an October virtual session.

FDA Advisory Committee Feature image

A US Food and Drug Administration panel will discuss the PMA for a system that helps keep donor hearts viable during the transplant process at a 7 October meeting, the agency announced in a Federal Register notice.

The meeting of the Circulatory System Devices Panel, initially scheduled for April, was postponed due to the coronavirus pandemic. It will now be held virtually.

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