FDA grants breakthrough device designation to Critical Innovations for its “F.O.A.M” device

Critical Innovations has received FDA breakthrough device designation for its “fast onset abdominal management” (F.O.A.M) device, which is designed to deliver a quickly-expanding foam to tamponade severe internal bleeding in trauma patients. The US Army Medical Materiel Development Activity (USAMMDA), through the Medical Technology Enterprise Consortium (MTEC), under a contract worth over one million [...]