concussion

BrainScope Announces Publication Describing Proprietary Concussion Biomarker to Assess Potential Severity and Predict Prolonged Recovery

BETHESDA, MD. January 15, 2019– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that researchers have published preliminary results related to a multi-modal concussion assessment capability for potential severity and likelihood of prolonged recovery from concussions.  Published in the peer-reviewed journal Computers in Biology and Medicine, the paper entitled, “A multimodal biomarker for concussion identification, prognosis and management” describes a study which enrolled 568 concussed and matched control patients between the ages of 13-25 from 29 colleges and 19 high schools.  Subjects were tested at the time of injury and at multiple time points during recovery. 

Results from this study demonstrated highly significant differences in the BrainScope biomarker between the 177 concussed patients and controls at the time of injury and no significant differences at clinically determined Return-to-Play.  Progressive recovery over time was also demonstrated, especially in the prolonged recovery group.  Results also supported the hypothesis that some of the more severely injured subjects may have been allowed to return to play too soon. 

BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment

BETHESDA, MD. January 2, 2019– 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.  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.”

BrainScope Honors Veterans Day and Supports U.S. Army Deployment of Traumatic Brain Injury (TBI) and Concussion Assessment Devices

BETHESDA, MD. November 13, 2018– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has fulfilled orders for over 170 BrainScope One handheld devices and over 7,500 individual patient headsets to U.S. Army bases across the world. U.S. Army medics and clinicians continue to receive the training necessary to support the assessment of military personnel that may have experienced an mTBI, providing access for service members at home and abroad.

BrainScope Receives Prix Galien Award Nomination for Its Concussion and Traumatic Brain Injury Assessment Product

BETHESDA, MD.--(BUSINESS WIRE)--BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for “Best Medical Technology” product. Its flagship BrainScope One product is a multi-modal, comprehensive, handheld capability to help clinicians objectively and rapidly assess and triage head injured patients directly at the point of care.