FDA approves EVLP platform for functional assessment of donor lungs prior to transplantation

On July 22, 2026, the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) to an
ex vivo lung perfusion (EVLP) system for functional assessment of donor lungs initially deemed unsuitable for transplantation. The system supports continuous normothermic machine perfusion, during which ex vivo lung function can be reassessed to determine suitability for lung transplantation in adults, with the potential to expand the donor lung pool. 

The system comprises a mobile cart with embedded software, a single-use sterile organ chamber and cannulae set, and a perfusion solution, and can be used for EVLP for up to 6 hours. The platform has been utilized in >400 procedures across collaborating transplant centers, with approximately 67% of evaluated marginal donor lungs subsequently accepted for transplantation. While the system facilitates evaluation of donor lungs, the final determination of suitability for transplantation remains the responsibility of the transplanting surgeon. There are no known contraindications.