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BrainScope initiates development of pediatric product for objective assessment of TBI

Press releases may be edited for formatting or style
BETHESDA, Md.--(BUSINESS WIRE)--BrainScope Company, Inc., the medical neurotechnology company which created the first FDA-cleared handheld medical device, BrainScope One, for assessment of the full spectrum of traumatic brain injury, announced it will immediately commence development of a pediatric capability. The pediatric product will be similar to the currently-available BrainScope One, which is a handheld, easy-to-use, rapid, objective capability to aid the clinician in the assessment of mildly presenting adult head injured patients at the point of care. It is designed to help the clinician assess the full spectrum of brain injury, including whether a patient has structural brain injury likely visible on CT, as well as whether a patient has functional brain impairment, including concussion. BrainScope One measures and interprets the patient’s brain electrical activity and neurocognitive function, and offers a panel of objective data to help physicians make their clinical diagnosis.

BrainScope will begin recruiting leading clinical sites around the U.S. to conduct clinical studies in a pediatric patient population for development of this first-of-its-kind product to objectively assess the full spectrum of brain injuries in adolescents and children.

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“We are excited to start development of a pediatric capability very much akin to that which we offer today with BrainScope One,” stated Michael Singer, CEO of BrainScope. “There is an urgent, obvious need for a rapid, objective medical device to help clinicians determine the presence of brain injury, including concussion, that a pediatric patient might sustain following head injury, particularly in sports environments but also in everyday life. In addition to the national discussion on concussions and their long-term consequences, clinicians are particularly concerned about radiation exposure in children from unnecessary head CT scans. This device has the promise to directly address both significant concerns.”

There are currently over 44 million children participating in sports such as football, soccer, lacrosse and many other sports where head injury occurs each year in the United States. It is estimated that there are up to 1.9 million sports- and recreation-related concussions in children annually in the U.S. Currently, many of these concussions are diagnosed using purely subjective, symptom-based methods. A recent study by the Institute of Medicine and the National Research Council Committee on Sports-Related Concussions in Youth noted, “As the diagnosis of concussion is currently based primarily on symptoms, there is a major need for objective diagnostic markers of concussion.”
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