FDA clears company to market TBI assessment device

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The Food and Drug Administration has given the go-ahead to BrainScope Company Inc. to market its Ahead 300, a medical device used for assessing traumatic brain injury.

Developed in partnership with the Department of Defense, the multimodal device allows clinicians a way to look at the full spectrum of TBI.

The Ahead 300 is the first product the company will sell commercially. It features BrainScope's patent-protected electroencephalography (EEG) capabilities using algorithms and machine-learning to analyze head-injured patient data. This will let healthcare professionals in settings such as clinics and skilled nursing facility objectively assess potential TBIs at the point-of-care.

“FDA clearance of the Ahead 300 is a bellwether moment in our company's history. 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,” stated Michael Singer, Chief Executive Officer of BrainScope.

BrainScope has received funding from companies that include Revolution, ZG Ventures and Difference Capital.


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