BrainBox, a Virginia Bio+Tech Research Park startup company, is making waves in its mission to provide better tools for diagnosing mild traumatic brain injuries suffered in accidents or sports-related injuries.
The company announced that the FDA has granted “breakthrough device designation” for a test trial the company has developed to aid in the diagnosis and prognosis of mild traumatic brain injuries, commonly known as concussions. The FDA’s “breakthrough device designation” is intended to help speed the development of medical devices by expediting the monitoring and approval process to help get the product to market more quickly.
The trial, HeadSMART II, uses a computer algorithm to provide a single measurement of the brain injury’s severity to help doctors determine the best treatment and is designed to spot injuries that are undetectable to CT Scans and MRI’s. It’s expected to take 18 to 20 months and will consist of over 700 patients from 20 sites worldwide where it’ll produce research to support the U.S. and international regulatory filings to bring the product to market.
Read the full story here.