BrainScope Company, Inc. announced that the United States Food and Drug Administration (FDA) has cleared the company to market the Ahead 300, its most advanced medical device for use in assessing traumatic brain injury (TBI). Developed in partnership with the U.S. Department of Defense, 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 represents an evolution from the three BrainScope products that have previously received FDA clearance, and with its substantial additional capabilities, will be the first product the company will sell commercially.
The Ahead 300 features BrainScope’s proprietary, patent-protected electroencephalography (EEG) capabilities utilizing sophisticated algorithms and machine learning to analyze head-injured patient data. 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.
“The BrainScope platform is a desperately needed addition to the medical provider's clinical armamentarium. With mild TBI as prevalent as it is, an objective easy-to- use point of care device to identify those patients at highest risk of concussion is a critical need,” added Geoffrey Ling, MD, COL, USA (Ret.). BrainScope has focused on developing medical technology substantiated by clinical evidence emanating from over 20 clinical studies at 55 clinical sites over the past eight years.
Stemming from this substantial clinical work, there is an extensive and growing bibliography of peer-reviewed publications underpinning the BrainScope technology. BrainScope has also developed a broad Intellectual Property portfolio now consisting of 100 issued and pending patents worldwide.
