The United States Food and Drug Administration (FDA) has cleared BrainScope Company Inc’s Ahead 200 device for adjunctive assessment of traumatic brain injury (TBI), according to a recent news release from the company.
Using commercial smartphone hardware that leverages Google’s Android operating system, the release notes that the device is built to record and analyze a patient’s electroencephalograph (EEG) using a custom sensor attached to the handheld to provide an interpretation of the structural condition of the patient’s brain post-head injury.
BrainScope announced in late 2012 that it had been awarded a $2.67 million contract by the US Army for development of the Ahead 200, a smaller, more modernized version of its Ahead 100 TBI assessment technology. The release notes that similar to the Ahead 100, which was cleared this past November, the device is indicated for use as an adjunct to standard clinical practice to assist in the evaluation of patients who are being considered for a head computerized tomography (CT) scan, but should not be used as a substitute for a CT scan. According to the release, it is intended to be used on patients who have sustained a closed head injury within 24 hours, are clinically present as a mild traumatic brain injury (mTBI), and are between the ages of 18 to 80 years old.
Michael Singer, president and CEO, BrainScope, emphasizes the company’s gratefulness for its continuing partnership with the Department of Defense.
“FDA Clearance of our Ahead 200 represents a significant achievement in BrainScope’s mission to develop an objective, noninvasive, patient-friendly assessment device for rapid and easy use in urgent care settings. A device with the ability to rapidly identify and categorize patients who present with mild symptoms but who may have a life-threatening TBI has the potential to improve triage, save lives, reduce radiation exposure and decrease costs to the healthcare system,” Singer says in the release.
The release reports that in September 2014, BrainScope was awarded three contracts valued at $15.93 million by the US Department of Defense for continued research and development of the Ahead system. These contracts, the release explains, support enhancement of BrainScope’s Ahead technology and current nationwide, multisite clinical studies in hospital emergency departments, and extend its TBI focus to concussion assessment technology.
Studies in concussed athletes are reportedly under way in cooperation with university sports programs. These activities, the release says, leverage 6 years of BrainScope studies in sports venues, including a study awarded through the GE-NFL Head Health Challenge I.
Singer adds in the release that the Ahead 200 project, in collaboration with the US Department of Defense, has yielded “another important FDA Clearance and has allowed us to leverage the ubiquitous Android mobile operating system and advances in handheld processing technology fueled by the smartphone market to develop and ultimately commercialize our products. We continue to refine the ultimate product through our ongoing clinical studies and technology development.”
According to the release, study results from independent clinical studies using BrainScope’s technology have been published through 15 articles in peer-reviewed neurotrauma and emergency medicine journals.
These journals include the Journal of Neurotrauma, Brain Injury, Academic Emergency Medicine, Journal of Head Trauma Rehabilitation, The American Journal of Emergency Medicine, and Military Medicine.