The Ahead 200 device, in development now, is similar to the Ahead 100 device recently cleared by the FDA. The Ahead 200 is being designed to work with a smart phone to quickly assess traumatic brain injuries. Credit: via BrainScope

BrainScope announced Wednesday it has received approval from the Food and Drug Administration for a monitoring device to help doctors assess the severity of traumatic brain injuries.

The clearance will allow the Bethesda company to market its Ahead 100 device, which can be used by doctors to determine if a patient has bleeding in the brain after suffering a head injury.

“It is a very, very important moment in the company’s history,” Michael Singer, president and CEO of BrainScope, said. “It gives us the ability to market this product and gives us the regulatory pathway for future products.”

The device is similar to a headband and has sensors that can monitor electronic brainwaves. It can detect if a patient’s electroencephalograph (EEG) is consistent with other patients who were determined to have suffered brain trauma.

The device was developed over six years by using clinical studies of brain injury patients conducted at emergency rooms across the country, according to the company. The studies helped the company develop the EEG profiles that are used to detect possible bleeding in the brain before a CT scan, according to Singer.

“A very large number of people in the U.S. go to an emergency room after having hit their head and one of the very big questions is should this patient receive a CT scan or not,” Singer said. “We’re focusing on a rapid instrument to help a clinician make that decision.”

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Eventually, Singer said, the company hopes its device can be used in emerging markets where CT scans are much less available.

Singer noted that the product looks solely at structural brain injuries, which are more serious than concussions. He says the company is also developing devices that can quickly identify concussions for use on sports fields and for military medical purposes.

Singer said an industry surrounding the assessment of brain injuries is growing due to greater public knowledge of the severity of problems associated with such injuries.  Much of that knowledge has come in the last five to 10 years from research on soldiers returning from Iraq and Afghanistan as well as on former football players, Singer said.

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“An objective, accurate capability that can rapidly 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,” Stephen Huff, a neurology associate professor at the University of Virginia School of Medicine, said in a statement. Huff is working with BrainScope to develop a similar device.

The Department of Defense has awarded the company more than $27 million in contracts to develop technology to quickly diagnose traumatic brain injuries—with the expectation that the devices could be deployed for use on battlefields.

“The partnership with the Department of Defense has been incredibly important,” Singer said.  “Without them we wouldn’t be where we are today.”

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The Maryland Venture Fund, an arm of the Maryland Department of Business and Economic Development, has also invested $900,000 in the business since 2011.

The company is currently studying collegiate athletes in sports such as football and soccer to determine how its devices could be used to assess brain injuries incurred while playing sports.

BrainScope, located at 4350 East West Highway, currently employs 20 people, but plans to grow to between 25 and 30 people soon, according to Singer.

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