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BrainScope Announces FDA Clearance for Smartphone Device Diagnosing TBI

October 3, 2016


BrainScope — a medtech specializing in traumatic brain injury (TBI) diagnostic technology that is backed by the U.S. Department of Defense (DOD)— has announced FDA clearance for Ahead 300, a hand-held medical device capable of objectively assessing the likelihood of TBI. The technology leverages advanced algorithms and machine learning to diagnose the “full spectrum” of TBI, and will be the first commercially launched product from BrainScope.

BrainScopeThe Ahead 300 system — which builds on previous BrainScope technologies — consists of a disposable paper cap with miniaturized electroencephalogram (EEG) technology, and transmits data to a smartphone device to be analyzed. In addition to EEG results, the Ahead 300 includes additional measures to provide a comprehensive panel of results in a point-of-care tool, designed to be used in emergency care environments, military operations, and sporting events.

Advances in machine learning and big data analytics played an important role in the development of BrainScope’s technologies, according to Leslie Prichep, chief scientific officer for BrainScope.  Prichep told MIT Review that “our ability to characterize electrical signals has just exploded” in the last ten years.

BrainScope CEO Michael Singer called the FDA’s clearance of the Ahead 300 a “bellwether moment” in the company’s history and noted in a press release that the technology could address the

“full spectrum of traumatic brain injury, from structural injuries visible on a CT scan, through mild TBI, also known as concussion.”

Since 2011, BrainScope has been the recipient of over $70 million in investments from both the private and public sectors, including the NFL and the DOD. Earlier this year, BrainScope was among a handful of companies featured at the NFL’s annual meeting as part of its “Vision 20/20 Tech Lab,” and was the grand prize winner of the Head Health Challenge I, part of a collaboration between NFL, GE, and Under Armour aimed at developing better diagnostic technologies for TBI.

In July, BrainScope announced the appointment of Andrew Holman as chief commercial officer. Holman’s previous 20 years’ experience in medical device marketing includes leadership roles at Boston Scientific, Johnson & Johnson, and Smith & Nephew.  In a recent press release, Holman remarked that BrainScope is “exceptionally well positioned” to become the new standard of care in TBI assessment.

Previous iterations of BrainScope technology, though cleared by the FDA, have been used primarily for research purposes, but the commercial launch of the Ahead 300 will be announced in coming months, said Singer.

Earlier this year, FDA hosted a public workshop where representatives from industry, military, and academia presented the latest advances in TBI research  and advised FDA on potential challenges posed by novel technologies. The agency recently cleared imPACT’s computerized cognitive concussion test,which is the first technology of its kind to be cleared for the U.S. market through FDA’s de novo classification.

In March, Abbott launched the largest ever single-centered TBI study in Minnesota, which will collect data from 9,000 patients and evaluate a range of potential approaches to TBI assessment, including blood biomarkers, imaging techniques, and digitized eye tracking.

Source: BrainScope’s Hand-Held Device Diagnoses “Full Spectrum” Of TBI Headed To US Market

Author: Suzanne Hodsden

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