TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month.
Andover, Mass.–based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021.
In the committee meeting, the FDA’s Gastroenterology & Urology Devices Panel of the Medical Devices Advisory Committee will discuss the platform, make recommendations and vote on a recommendation for approval of the OCS Liver System, according to a news release.
“We are looking forward to presenting the OCS Liver PROTECT data to the advisory committee panel in support of our PMA for the OCS Liver System,” TransMedics president & CEO Dr. Waleed Hassanein said in the release. “This is another important milestone to bring TransMedics closer to having all of our three organ platforms approved by FDA in 2021.”