FDA Advisory Committee Gives Thumbs Up To TransMedics' OCS Liver System

The Gastroenterology and Urology Devices Panel of the FDA's Medical Devices Advisory Committee has issued a favorable vote to support the approval of TransMedics Group Inc's TMDX OCS Liver System.
The panel voted 14 to 0 that there is reasonable assurance that the OCS Liver System is effective and 14 to 0 that there is reasonable assurance of the OCS Liver System's safety.
The panel voted 12 to 1, with one abstaining, that the benefits of the OCS Liver System outweigh its risks.
The OCS Lung System is approved in the U.S., and the OCS Heart System is currently under review by the FDA after receiving a positive vote by the FDA's Circulatory System Device Advisory Panel in April.
The Organ Care System (OCS) is a fully portable, multi-organ, normothermic preservation and assessment technology that mirrors human physiology, minimizes ischemia, and provides the ability to optimize the organ during transport.
Price Action: TMDX shares closed at $31.69 on Wednesday.
Related content: Benzinga's Full FDA Calendar.

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