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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