TransMedics Heart Transplant Tool Lands FDA Panel Date After 6-Month Delay
The US agency’s circulatory system devices panel will take up the company’s heart transplant tool in an October virtual session.
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The company said the postponement will give the US FDA additional time to review trial data.
FDA approved a PMA supplement to allow TransMedics' Organ Care System (OCS) to be used for the preservation and ex-vivo assessment of lungs that would not be acceptable for transplant if they had been preserved with a standard cold static system.
The user fee package was among several health-related bills that the subcommittee took up on Wednesday.