TransMedics' OCS Heart System Scores FDA Approval

by Vandana Singh, Benzinga Editor

September 7, 2021 11:11 AM | 1 min read |

TransMedics Group Inc TMDX has received FDA premarket approval (PMA) for its OCS Heart system.
Related content: Benzinga's Full FDA Calendar.
TransMedics designed its OCS Heart system for use with organs from donors after brain death (DBD) with an indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation.
Premarket approval follows FDA approval for and the subsequent commercialization of the OCS Lung system.
The company continues to seek FDA approval for the OCS Liver system.
Related Content: FDA Advisory Committee Gives Thumbs Up To TransMedics' OCS Liver System.
Price Action: TMDX shares are down 0.80% at $32.41 during the market session on the last check Tuesday.