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BRAINBox Solutions Announces Enrollment Begins in Pivotal, HeadSMART II Clinical Study of BRAINBox TBI Concussion Diagnostic and Prognostic Test
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RICHMOND, Va., Dec. 16, 2020 /PRNewswire/ BRAINBox Solutions today announced it is beginning enrollment in its pivotal clinical trial, HeadSMART II (
Head injury
Response to
Trauma), of the company s concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site trial, which will enroll up to 2,000 patients, aims to generate data to support an application for regulatory clearance by the U.S. FDA.
The BRAINBox TBI (Traumatic Brain Injury) test will be the first objective test designed to assist in the diagnosis of concussion and provide an assessment of the risk of chronic injury. The FDA has granted the test Breakthrough Device designation. ....

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