FDA permits first blood test detecting concussion, a docile traumatic brain injury (mTBI), in adults. Conventional concussion evaluation used to involve a CT scanning of head for detecting damage in any of the brain tissues. However most of the people after having such a type of scan don’t have brain damages, which are detectable in the treatment, according to the statement given by the FDA in a news release on Wednesday.
Scott Gottlieb, M.D., Commissioner of the US Food and Drug Administration said in a statement during the Wednesday’s news release that, “Helping to deliver innovative testing technologies that minimize health impacts to patients while still providing accurate and reliable results to inform appropriate evaluation and treatment is an FDA priority.”
The U.S. Food and Drug Administration now allows to market the first ever blood test evaluating the concussion. As a part of the Breakthrough Devices Program conducted by the FDA, the government health organization has authorized and reviewed for the marketing of Banyan Brain Trauma Indicator for less than 6 months.
FDA commissioner, Gottlieb added that, “Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging—an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose. In addition, availability of a blood test for TBI/concussion will likely reduce the CT scans performed on patients with concussion each year, potentially saving our health care system the cost of often unnecessary neuroimaging tests.”