Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.
XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.