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FDA Clears Diagnostic Device for Traumatic Brain Injuries

September 30, 2016
The FDA has cleared for marketing a new portable diagnostic device for assessing brain injury in patients, the first device of its kind.

Photo courtesy of BrainScope

Doctors soon could have an effective, mobile tool for diagnosing traumatic brain injuries (TBI) in patients, using just a disposable headset and a smartphone.

The US Food and Drug Administration (FDA) has cleared for marketing a new multimodal device for assessing TBI in patients. Developed in partnership with the Department of Defense, the Ahead 300 device will be the first commercially available product by its manufacturer, BrainScope.

Featuring the company’s proprietary, patent-protected electroencephalography (EEG) technology, the device uses “sophisticated algorithms and machine learning” to analyze clinically relevant measures in patients, helping doctors to better diagnosis TBI and related trauma, including concussions, according to the company’s press release.1

“The BrainScope platform is a desperately needed addition to the medical provider's clinical armamentarium. With mild TBI as prevalent as it is, an objective easy-to-use point of care device to identify those patients at highest risk of concussion is a critical need,” said Geoffrey Ling, MD, COL, USA (Ret.).

The Ahead 300 device uses a disposable electrode headset that provides a rapid assessment of patients presenting with mild symptoms suggestive of presence of TBI. “In addition to EEG capabilities, the Ahead 300 includes additional assessments providing clinicians with a digitized, streamlined report, delivering a comprehensive and objective panel of results to facilitate their differential diagnosis,” the company wrote.

Over the last decade, concussions have become a prevalent issue in athletics, but athletes are not the only people who suffer from concussions. In 2010, some 2.5 million visits to the emergency department (ED) were related to a TBI alone or in combination with other injuries. Falls have been the leading cause of TBI’s, with 81% of TBI’s in older adults (aged 65 years or older) occurring as the result of a fall. In children (aged 0 to 14 years), falls also are prevalent cause of concussions, associating with over 55% of TBI cases.2

"The Ahead 300 provides the specific capabilities needed today for the clinician to undertake a comprehensive assessment addressing the full spectrum of traumatic brain injury, from structural injuries visible on a CT scan, through mild TBI," said Michael Singer, chief executive officer of BrainScope, in the company’s press release.

The Ahead 300 device is also portable and convenient enough to be used in various healthcare settings, including emergency care centers in hospitals, concussion clinics, and various settings of the military healthcare system. Because of the product’s convenient design, practitioners can use the device right at the point of care, which could make it a useful tool for assessing athletes, who are oftentimes the victim of TBI-related injuries on the playing field

Having the ability to rapidly identify and diagnose patients stricken with a TBI could be a major step forward for reducing morbidity and mortality. Doctors note there has been no clear decrease in mortality related to TBI in the last 2 decades, and there is now a significant need for more standardized epidemiological diagnosing and monitoring of TBI.3

Since 2011, BrainScope has worked in close partnership with Department of Defense, being awarded over 27 million dollars in research contracts to aid in the development of the technology behind the Ahead 300 device. “BrainScope has focused on developing medical technology substantiated by clinical evidence emanating from over 20 clinical studies at 55 clinical sites over the past eight years. Stemming from this substantial clinical work, there is an extensive and growing bibliography of peer-reviewed publications underpinning the BrainScope technology,” the company wrote.

The company now is preparing to commercialize the Ahead 300 device with an expected launch coming in the next few months.

Last updated on: October 3, 2016
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