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BrainScope has commercialized the first FDA-cleared AI/machine learning-enabled medical device in neurology for point-of-care head injury assessment. Its system enables rapid, objective triage of mild traumatic brain injuries—demonstrated to reduce unnecessary CT scans by up to ~50%—and provides validated concussion assessments. The company has completed proof-of-concept studies showing its EEG-based digital biomarkers can predict early cognitive decline before structural damage appears. Ongoing development includes new markers for Alzheimer's risk, ARIA detection, stroke evaluation, concussion subtypes, military blast exposure effects, and “brain fog.” Clinical validation includes over a decade of multi-site studies with peer-reviewed publications.
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