BrainScope, a company out of Bethesda, Maryland, received FDA de novo clearance for its Ahead 100 EEG-based system for identifying patients who should get a CT scan of the brain following an injury to the head. The device is not intended to replace CT scans, but is to be used as an adjunct to typical practice in deciding whether to proceed with a CT scan in adults who present with symptoms of mild traumatic brain injury.
The Ahead 100 device was created by gathering EEG readings from people with brain injuries coming through emergency rooms and then using this data to identify markers of injury. The resulting database is used as a template for the device in order to match the patient’s EEG graph to signs of serious brain injury. The Department of Defense, for obvious reasons, is excited about this new technology and has been sponsoring its development.
From the announcement:
BrainScope recently completed development of a prototype miniaturized Ahead® system using existing smartphone technology that will be utilized for all future development activities. In September, BrainScope announced that it had been awarded three contracts valued at $15.93 million by the United States Department of Defense (DOD) for continued research and development of the Ahead® system. These contracts will support further clinical studies and development of BrainScope’s Ahead technology in hospital Emergency Departments, and further its Traumatic Brain Injury (TBI) focus to concussion assessment technology with clinical studies in cooperation with university sports programs. These activities leverage six years of BrainScope studies in sports venues, including a current study with the Purdue Neurotrauma Group funded through the GE-NFL Head Health Challenge I.
“The FDA-cleared Ahead® 100 is our first generation technology. Over the last two years, we have focused on improving this technology, including adapting it for use on ubiquitous hardware platforms such as smartphones and tablets, and by benefitting from machine learning and proprietary algorithm classification techniques from increased data derived from our numerous clinical studies. We will direct all of our commercialization efforts for the Ahead® product family using these hardware platforms both for assessment of structural brain injury in urgent care settings, and for assessment of concussion on the battlefield and the sports field. We also have an eye to the future with our technology showing promise in other neurological indications, such as stroke and cognitive decline,” stated Singer.
Results from independent clinical studies utilizing BrainScope’s technology have been published through 14 articles in leading peer-reviewed neurotrauma and emergency medicine journals such as Journal of Neurotrauma, Brain Injury, Academic Emergency Medicine, The Journal of Head Trauma Rehabilitation and The American Journal of Emergency Medicine.