Great news for TransMedics!
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 MassDevice.com via email.
Bayard Design consultant Matthew De Remer designed the ventilator system for the OCS Lung.