BrainScope scores FDA clearance for smartphone-based device for TBI

BrainScope got FDA clearance for its handheld medical device for diagnosing traumatic brain injury (TBI). The news is a feather in the company’s cap as it builds out its offerings and preps its latest device for commercialization.

The Bethesda, MD-based company’s Ahead 300 device uses electroencephalography (EEG) technology to pinpoint TBI in patients with head injuries. The system runs through a smartphone and includes a disposable electrode headset, allowing doctors to quickly assess whether an individual has TBI.

BrainScope’s device responds to a prevalent healthcare issue. More than 5 million U.S. patients are seen each year with closed head injuries, and millions more do not have their injury evaluated, the company said in a statement.


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Ahead 300 is meant for point-of-care settings, including intercollegiate and professional sports settings, where a quick diagnosis can prevent complications or patient death.

FDA clearance for Ahead 300 is a “bellwether moment” in BrainScope’s history and “represents many years of development” with the U.S. Department of Defense (DOD), BrainScope CEO Michael Singer said in a statement.

The DOD has already awarded the company more than $27 million in contracts to develop its Ahead system for soldiers with brain injuries. Last year, the FDA cleared another one of BrainScope’s smartphone-based EEG devices for TBI.

Now, with FDA clearance for its newest device in tow, BrainScope is looking toward commercialization. The company is prepping to launch Ahead 300 “in the coming months” and will “be making a formal announcement upon our commercial launch” of the product, Singer said.

Meanwhile, BrainScope continues to rake in funds to support product development. In addition to the DOD, private investors including Revolution, ZG Ventures and Brain Trust Accelerator Fund have already backed the company’s efforts.

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