BrainScope said today that it won FDA clearance to include new indication language for its BrainScope One concussion assessment device.
Following a multi-parameter assessment, the company’s device can determine the likelihood of the presence and severity of a concussion or mild traumatic brain injury.
“This additional FDA labeling for our product, BrainScope One, recognizes the unique capabilities of our FDA-cleared medical device with labeling distinctively and specifically for this particular disease state,” CEO Michael Singer said in prepared remarks.
“Years ago in working with our partner, the Department of Defense, we realized and learned from them the importance of multi-modality and objectivity. Combining a full range of concussion assessment capabilities on one handheld platform provides the clinician a timely and easy-to-use tool for collecting the objective data they need to facilitate their clinical diagnosis, right then and there, for this debilitating brain disease state.
For over a decade, we have created a platform comprised of unparalleled AI-based technology, clinical evidence, peer-reviewed literature and regulatory knowledge, supported by a vast IP portfolio. Given our success in developing BrainScope One for mTBI and concussion assessment, we have received considerable interest from third-parties to further develop the BrainScope multi-modal assessment platform for other neurological disease states beyond concussion,” Singer added.