An exciting new technology received FDA clearance according to a press release put out by BrainScope on September 26, 2016. According to the press release, BrainScope announced that the FDA has cleared the company to market the Ahead 300, “its most advanced medical device for use in assessing traumatic brain injury.” The product was developed in partnership with the US Department of Defense.
According to the release, 95% of people who go to the emergency room have mild symptoms. These are not always diagnosed as a concussion or Traumatic Brain Injury (TBI.) As we discussed in other posts even mild concussions can cause long term effects in injured patients, particularly children. The Ahead 300 advances diagnosis of TBI using proprietary smart phone and electroencephalography (EEG) technology. It allows for fast indication of TBI so that treatment can be administered immediately in the ER or at the doctor’s office. The tool also provides “clinicians with a digitized, streamline report delivering a comprehensive an objective panel of results to facilitate their differential diagnosis.”