New Brain Injury Assessment Tool Gets Cleared By The FDA

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The U.S. Food and Drug Administration (FDA) recently approved a new handheld medical device used to assess brain injuries soon after they happen. The Ahead 200 was cleared by the FDA in May 2015 to assist clinicians in evaluating mildly-presenting brain injury patients.

The device was developed by the U.S. Army Medical Research and Material Command’s Combat Casualty Care Research Program, or CCRP, and the BrainScope Company, Inc. and uses already available smartphone technology to examine a patient’s brain activity for signs of traumatic brain injury (TBI) 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 Ahead 200 works by measuring the brain’s electrical activity using a disposable headset that is placed around the forehead. Once the electrical activity is recorded, the device uses a set of algorithms which quantify and characterize activity linked with traumatic brain injuries. The developers intend the tool to be used in conjunction with other tools on the market to improve the accuracy and speed of assessing individuals with potential brain injuries, especially those in the military.

“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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