The changes add key terminology related to “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and clarified overall IFU.In addition to being able to objectively and reliably identify patients who may have a brain bleed using the product’s Structural Injury Classifier, BrainScope One uses the same electroencephalogram (EEG) signal and other capabilities on the device to objectively determine the likelihood of the presence and severity of a concussion.
All capabilities are summarized on a panel of multimodal, multi-parameter results, greatly facilitating clinical concussion assessment.
“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,” stated Michael Singer, CEO of BrainScope. “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.”
“Throughout most of 2018, we maintained an interactive dialogue with the FDA on the labeling pertaining to our concussion assessment capabilities and, as part of this ongoing discussion, we provided substantial data for their consideration. This has led to BrainScope’s 6th FDA Clearance. This thorough vetting by the FDA shows our commitment to and respect for adherence to the regulatory process as it relates to human brain health, and in particular to the increasing national awareness of the significant problem of concussion,” added Singer.
BrainScope further announced that with a global patent portfolio of over 100 issued and pending patents, a substantial portion of these patents relate specifically to multi-modality capabilities applicable to all neurological conditions and disease states.
“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,” stated Singer.
