BrainScope said it won 510(k) clearance from the FDA for its Ahead 100 device, designed to detect traumatic brain injury.
The Ahead 100 uses a patient’s EEG readings to help determine the structural condition of the brain. The handheld device is intended to help evaluate whether a patient should receive a CT scan, but should not be used in place of a scan, BrainScope said.
The Ahead 100 is cleared for use in patients aged 18 to 80 who have sustained a head injury in the last 24 hours, according to a press release.
“Each year there are approximately 2 million patients in the U.S. alone who sustain head injuries and go to emergency departments for evaluation,” Dr. J. Stephen Huff of the University of Virginia School of Medicine said in prepared remarks. "Many of these patients present with very mild symptoms, yet may have life-threatening bleeds in the brain. An objective, accurate capability that can rapidly help identify and categorize patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system.”
In September, BrainScope won nearly $16 million in contracts from the U.S. Defense Dept. to further develop its concussion-detection technology. The company said that it’s won more than $27 million in DoD research grants over the years. BrainScope is also testing the technology for sports-related head trauma under a grant from the National Football League’s Head Health Challenge I initiative, according to the release.
“Over the last 2 years, we have focused on improving this technology, including adapting it for use on ubiquitous hardware platforms such as smartphones and tablets,” CEO Michael Singer said in a statement.”We will direct all of our commercialization efforts for the Ahead product family using these hardware platforms both for assessment of structural brain injury in urgent care settings, and for assessment of concussion on the battlefield and the sports field. We also have an eye to the future with our technology showing promise in other neurological indications, such as stroke and cognitive decline."