FDA Clears Handheld Device for TBI Assessment

Megan Brooks


September 28, 2016

The US Food and Drug Administration (FDA) has cleared for marketing a handheld device to assess the full spectrum of traumatic brain injury (TBI), including concussion, the company has announced.

The Ahead 300 device from BrainScope was developed in partnership with the US Department of Defense. It combines proprietary electroencephalography (EEG) technology, sophisticated algorithms, and machine learning with smartphone technology and a disposable electrode headset to provide rapid and objective assessment of the likelihood of the presence of TBI in patients who present with mild symptoms at the point of care, the company notes in a statement dated September 26.

These include hospital emergency departments, urgent care centers, and concussion clinics and sites throughout the military healthcare system. The device can also be used in intercollegiate and professional sports settings to aid decision making.

Ahead 300 device. Courtesy of BrainScope

"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," the company explains in a news release.

"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," added Michael Singer, chief executive officer of BrainScope.

"The BrainScope platform is a desperately needed addition to the medical provider's clinical armamentarium," commented Geoffrey Ling, MD, COL, USA (Ret.). "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."

Since 2011, BrainScope has received over $27 million of research contracts by the US Department of Defense for research and development of the Ahead system. These contracts supported the evolution and enhancement of BrainScope's Ahead technology and clinical studies in hospital emergency departments, the company said.

The company is now preparing to commercialize the Ahead 300 device, which they expect to be available in the coming months.

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