Traumatic brain injuries including concussion are among the most common and challenging diagnoses for a physician to make in an Emergency Department, especially in patients presenting with mild head injuries. BrainScope gives Emergency physicians and staff greater assurance to rapidly and objectively assess the full spectrum of brain injury, including the likelihood of a structural component to the injury (one likely visible on CT) and the likelihood of a functional component to the injury (such as concussion).
When patients hurt their heads, where do they go? Your urgent care can be an option. The revolutionary, EEG-based, BrainScope One head injury assessment device allows for assessment at the point of care. It provides economic value to your practice while delivering comprehensive, objective assessment results that help guide providers in the early intervention of both structural and functional injuries, including concussion, allowing for better outcomes and superior patient care.
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.”