BRAINBox Solutions today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s BRAINBox TBI (Traumatic Brain Injury) test in development, the first to aid in both the diagnosis and prognosis of mild TBI (concussion). The BRAINBox TBI test is a multi-modality, quantitative test that combines injury-related blood protein biomarkers with computerized neurological assessments.
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