TransMedics (NSDQ:TMDX) has won FDA clearance of its OCS Lung System to provide hypothermic flushing, storage and transportation of donor lungs for transplantation.
“This FDA clearance marks another achievement for TransMedics as we assemble the most comprehensive, market-leading portfolio of organ preservation products to meet the clinical needs of the organ transplant market,” TransMedics CEO Dr. Waleed Hassanein said in a news release.
“With this new clinical indication, we are demonstrating our commitment to establishing TransMedics as the trusted partner to supply world-class organ preservation products to meet customer needs across all transplant indications as we execute on our mission to transform organ transplant therapy for the future,” Hassanein said.
The company’s OCS Heart System and OCS Liver System are presently under FDA after receiving positive FDA advisory panel votes in April and July respectively.