ALung: ALung gets FDA de novo clearance for Hemolung

Pittsburgh-based ALung Technologies Inc. has received clearance from the U.S. Food and Drug Administration for its premiere product, the Hemolung Respiratory Assist System, which helps patients with acute respiratory distress. The de novo review determined that the benefits of the medical device, developed out of the University of Pittsburgh, outweighs any risks. It's the first low-flow extracorporeal carbon dioxide removal technology that has received de novo clearance from the FDA, and is the...