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Medical Devices / Submissions and Approvals

BrainBox Solutions Gains Breakthrough Designation for TBI Test

June 7, 2019

The FDA granted BrainBox Solutions a breakthrough designation for its traumatic brain injury (TBI) diagnostic test designed to help in the diagnosis and prognosis of mild concussions in emergency departments and urgent care centers.

The test is intended for patients 18 and older and is used in point-of-care settings and clinical laboratories. It generates a single score incorporating data from all test components, as well as additional data that helps to guide treatment.

The multiplex fluorescence immunoassay uses a panel of in-vitro diagnostic serum measurements in addition to computerized neurological assessments.

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