BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other acquired traumatic brain injuries, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Tbit™ System for the prediction of positive computerized tomography (CT) scans following Traumatic Brain Injury (TBI).
February 11, 2019
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