TransMedics Group, Inc. (NASDAQ:TMDX) received premarket approval (PMA) from U.S. Food and Drug Administration (FDA) for its OCS™ Heart System in favour of use with organs from donors after circulatory death (DCD).
This approval is based on the results of the OCS™ DCD Heart Trial and the associated Continued Access Protocol (CAP) and stands to significantly expand the pool of eligible donor hearts in the United States.
