BrainScope announced today that the FDA has cleared the company to market the Ahead 300, its most advanced medical device for use in assessing TBI. Developed in partnership with the DoD, the Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinicians a comprehensive panel of data to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead 300 features BrainScope’s proprietary EEG capabilities utilizing sophisticated algorithms and machine learning to analyze head-injured patient data. 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.
“We are now preparing to commercialize the Ahead 300, which we expect to be available in the coming months. We will be making a formal announcement upon our commercial launch of the Ahead 300,” commented Michael Singer, CEO of BrainScope.