XVIVO has received market approval (PMA) from the FDA for STEEN Solution™ and XPS™
On April 26, 2019 XVIVO received Premarket approval (PMA) from the FDA for the products XPS™ and STEEN Solution™ for sale on the American market. The approval means that STEEN Solution™, XPS™ and the accompanying single-use articles are the only medical device products that are approved for Ex Vivo Lung Perfusion (EVLP) of initially unacceptable donated lungs at body temperature.Please see FDA press release on the following link: https://www.fda.gov/news-events/press-announcements/fda-approves-device-help-increase-access-more-lungs-transplant Just over 40 percent of all lung