BrainScope Launches Next-Gen Medical Device: First and only FDA-cleared system for true point-of-care assessment of both concussion and brain bleeds now includes Concussion Index
FDA-cleared Concussion Index is the only brain activity-based biomarker for rapid, objective baselining and assessment of concussion at injury and recovery time points
Bethesda, MD -- BrainScope today announced the availability of its third groundbreaking FDA-cleared algorithm on the BrainScope device. The Concussion Index is the first physiological marker of concussive injury that aids clinicians in the objective assessment of patients at baseline, point of injury, and through recovery. The Concussion Index adds to the suite of FDA cleared algorithms already available on the BrainScope device and in clinical use today to rapidly triage suspected mild traumatic brain injuries, from brain bleeds to concussion. BrainScope has been demonstrated to have the potential to reduce the use of head CAT Scans by more than 30% when used by Emergency Departments in triage, sparing patients unnecessary brain radiation while also providing an important assessment of concussion. It fits easily into any clinical workflow as it is fast and portable.
The company's disposable headset connects to its handheld device which acquires, processes and analyzes thousands of brain activity based physiological parameters, transforming them into a single index by using artificial intelligence algorithms. The results are immediately available and enable doctors to get rapid, objective insights about the likelihood of brain bleeds and concussions.
“With the addition of the AI-derived Concussion Index, BrainScope adds important new baselining and follow-up capabilities to aid physicians in concussion management,” said Susan Hertzberg, CEO of BrainScope. “The device operates on a battery charge, making it an ideal choice for assessments on the playing fields or battlefields.” Hertzberg added, “BrainScope does not require a blood draw or processing in a lab - it is completely non-invasive, truly point-of-care and takes less than 20 minutes from patient prep to results.”
“Within minutes I’m able to reassure my patient—with 99% sensitivity—that they do not have a significant intracranial injury,” said Mark Christensen, MD, Regional Director, Alteon Emergency Medicine – North Alabama. “And for concussions, BrainScope helps me communicate with my patients not just that they’ve had a concussion, but how severe it is— providing them with additional care that goes beyond the usual ‘Head CT and out the door’ approach to head injury assessment.”
Dr. Leslie Prichep, Chief Scientific Officer at BrainScope added, “BrainScope really does it all. At the ER, where millions of head injured patients first seek care each year, BrainScope aids in the rapid and accurate triaging of the likelihood of a brain bleed while also assessing the severity of functional impairment. In concussion management, the Concussion Index provides clinicians with actionable, objective insights that can inform patient management.”
The hand-held BrainScope device and disposable headsets are available today for sale through the company and must be used with a physician’s order. The company is currently taking orders on the enhanced BrainScope device and has begun the first customer placements and trainings.