FDA clears TransMedics transplant OCS Liver System

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TransMedics Group (NASDAQ:TMDX) received premarket approval from the FDA of its OCS Liver System for use with organs from donors after brain and circulatory death.

“We are extremely proud of this approval of our OCS Liver technology, as it represents the first and only liver perfusion technology to be approved by the FDA in the United States,” Waleed Hassanein, M.D., president and CEO of TransMedics, said in a statement.

“TransMedics’ OCS perfusion technology now covers lung, heart and liver transplantation.” 

“Our goal is to leverage these FDA approvals to make more donor organs available to help patients in need of the life-saving transplant procedure,” Dr. Hassanein said. “We are looking forward to expanding our commercial activities with all three OCS Systems starting in the fourth quarter of 2021.”