BrainScope’s Diagnostic Device for TBI/Concussion Cleared by FDA

By Debbie Gregory.

BrainScope, a Maryland-based biotech firm is working on an easier way to diagnose concussions. The medical neuro-technology company  has developed a medical device to aid in the assessment of traumatic brain injury (TBI) and its milder forms (concussion) at the initial point of care.

The handheld, wearable Ahead 300 device uses electrodes to measure electronic activity inside your brain and transmit readings to a reconfigured Android smartphone. The company recently received clearance from the federal Food & Drug Administration to market the device.

The Ahead 300 features BrainScope’s proprietary, patent-protected electroencephalography (EEG) capabilities utilizing sophisticated algorithms and machine learning to analyze head-injured patient data.  Leveraging state-of-the-art handheld smartphone technology and a proprietary disposable electrode headset, the Ahead 300 provides a rapid, objective assessment of the likelihood of the presence of TBI in patients who present with mild symptoms at the point of care. In addition to EEG capabilities, the Ahead 300 includes additional assessments providing clinicians with a digitized, streamlined report, delivering a comprehensive and objective panel of results to facilitate their differential diagnosis.

“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’s devices are focused on TBI in military, sports, and emergency/urgent care environments both in the U.S. and internationally.

The Department of Defense invested $27 million into the project in search of better ways of assessing traumatic brain injury among service members.

The technology was developed by the late Dr. E. Roy John and Leslie Prichep, a husband and wife duo of neuroscientists from New York University.

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