BrainScope Secures FDA Clearance for Ahead 200

BrainScope’s Ahead 200 device has won FDA 510(k) clearance, the Bethesda, Md., devicemaker announced Monday. The product takes advantage of smartphone technology and Google’s Android operating system to record and analyze electroencephalographs, using a special sensor to evaluate a patient’s brain following head injury.

The second-generation brain injury assessment device has been indicated as an adjunct to standard clinical practice, including for patients undergoing a computerized tomography scan. As part of BrainScope’s multicenter ongoing clinical trials, the company is conducting studies on concussed athletes in collegiate sports.

The devicemaker has received more than $27 million in research and development funds from the Department of Defense. — Jason Scott