BrainScope Ahead 300 510k K161068 – FDA Interactive Response

In this letter dated September 26, 2016, the U.S. Food and Drug Administration (FDA) approved an application from BrainScope to market a mobile concussion testing device called Ahead 300.  BrainScope developed the Ahead 300 in a partnership with the U.S. Department of Defense. The Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinical professionals a comprehensive panel of data to assist in their diagnosis of the full spectrum of traumatic brain injury (TBI), including concussion in people who present with mild symptoms at the point of care, including sports sidelines . . .