FDA Approves LungFX™ Device for Centralized Ex Vivo Lung Perfusion

The U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) to United Therapeutics Corporation's LungFX™ device. This device is designed for centralized ex vivo lung perfusion (EVLP), a procedure that allows donor lungs to be assessed outside the body before transplantation. The approval is based on comprehensive safety and effectiveness data, enabling re-assessment of donor lungs for patients aged 18 or older with end-stage lung disease.