FDA clears new traumatic brain injury assessment device

FDA clears new traumatic brain injury assessment device

A new handheld medical device for analyzing brain injuries has been cleared by the U.S. Food and Drug Administration. In May 2015, the Ahead 200 was cleared by the FDA to help clinicians assess mildly presenting head trauma patients.

The device, which was developed by the U.S. Army Medical Research and Materiel Command’s Combat Casualty Care Research Program, and the BrainScope Company, Inc., uses commercial smartphone technology to analyze a patient’s brain activity for signs of a traumatic brain injury within 24 hours of the injury.

“Traumatic brain injuries have been one of the signature injuries in Iraq and Afghanistan,” said Lt. Col. Chessley Atchison, program manager for the Technology Enabled Capability Demonstration: Brain in Combat portfolio of the CCCRP. “There is a great need for a tool like this in theater. A normal (electroencephalogram) machine is a big piece of machinery and can’t be used in the field.”

The device works by measuring the brain’s electrical activity via a disposable headset that is placed on the forehead. Once recorded, the Ahead 200 uses algorithms, which quantify and characterize activity associated with traumatic brain injuries. Used in conjunction with other tools, the Ahead 200 medical device will help assist clinicians in the real-time screening and care of warfighters with head injuries.

“The size and ease of use of the Ahead 200 allows medics to triage wounded warfighters quickly,” Atchison said. “Our goal is to not only save lives, but to ensure the best possible outcome for those injured in the line of duty, and tools like the Ahead 200 help us reach that goal.”

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