According to the Augusta Free Press a portable test that can diagnose signs of concussion and mild traumatic brain injuries (mTBIs) has received a ‘Breakthrough Device Designation’ from the U.S. Food and Drug Administration (FDA). The designation means the device will receive an expedited evaluation from the FDA once the product is deemed, by its creators, ready for public use.
The device was developed by BRAINBox Solutions, an innovator in the field of molecular diagnostics, which is focused on brain injuries. The company works alongside the Fralin Biomedical Research Institute at Virginia Tech. The device — which simultaneously tests for injury-related blood-protein biomarkers and evaluates highly sensitive imaging of the brain — is due for further testing at Virginia Tech.