BrainScope Gets FDA Approval for Traumatic Brain Injury Assessment Tech; Michael Singer Comments

BrainScope has received marketing clearance from the Food and Drug Administration for a medical device the neurotechnology company designed to help clinicians examine traumatic brain injury cases.

Bethesda, Maryland-based BrainScope said Monday it developed the Ahead 300 multi-modal device in collaboration with the Defense Department.

“FDA clearance of the Ahead 300 is a bellwether moment in our company’s history,” said Michael Singer, CEO of BrainScope.

“The Ahead 300 provides the specific capabilities needed today for the clinician to undertake a comprehensive assessment addressing the full spectrum of traumatic brain injury, from structural injuries visible on a CT scan, through mild TBI, also known as concussion,” Singer added.

The device is built with BrainScope’s electroencephalography systems that use algorithms and machine learning to analyze data of patients with head injury.

Singer noted the company expects to roll out Ahead 300 in the commercial market in the coming months.