U.S. FDA grants Critical Innovations breakthrough device designation for its F.O.A.M.™ device
Critical Innovations announces today that the FDA has granted breakthrough device designation for its "Fast Onset Abdominal Management™...
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Overview
Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 20 different Department of Defense awards from all three military branches charged with medical technology development (i.e. U.S. Army, Air Force, and Navy), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, and Other Transactional Authority. As a prime contractor, Critical Innovations currently has a 100% transition rate from Phase I to Phase II, as well as Phase II to Phase III, for all eligible SBIR programs.
Our Devices
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