New Concussion-Specific FDA Labeling Adds to Existing BrainScope Claims
The company’s innovative BrainScope One system is an easy-to-use, non-invasive, hand-held platform that empowers physicians to make more accurate TBI assessments quickly and at the point-of-care. BrainScope’s unique system leverages advanced digital signal processing, sophisticated algorithms and machine learning technologies to identify and evaluate key brain electrical activity biomarkers of TBI. BrainScope One also includes digitized versions of standard clinical assessments for milder forms of TBI known as concussion. (Photo: BrainScope Company Inc.)
"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”
BETHESDA, Md.--(BUSINESS WIRE)--BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has received FDA clearance to include additional language in its product’s Indications for Use (IFU), adding 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.
Comments