The 510(k) submission for this capability is currently under review by FDA.
About BrainScope
BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization. The company is a two-time winner of the GE-NFL Head Health Challenge and has received two nominations for the Prix Galien Best Medical Technology (in 2017 and 2018), regarded as the equivalent of the Nobel Prize for medical devices. The company’s initial product, BrainScope One, is now being used in numerous military divisions and in health systems, urgent care centers and universities.
This work was completed under Contract No. W911QY-14-C-0098 entitled “Objective Brain Function Assessment of mTBI from Initial Injury to Rehabilitation and Treatment Optimization” by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the US Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division.
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