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Gastroenterology & Urology Devices panel

FDA panel recommends approval for TransMedics lung transplant device

May 18, 2017 By Brad Perriello

An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures. The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Gastroenterology & Urology Devices panel, Organ Transplant, transmedics

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