The United States Food and Drug Administration (FDA) has cleared Brainscope Company Inc’s Ahead 100 device through the de novo classification process, according to a news release from the company. Ahead 100 is designed to use a patient’s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain post-head injury. The release adds that it is intended to serve as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for head computerized tomography (CT) scan, but should not be used as a substitute for a CT scan. It is built to be used on patients who have sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury, and are between the ages of 18 to 80 years old.
Dr Stephen Huff, associate professor of Emergency Medicine and Neurology at the University of Virginia School of Medicine and the Clinical Principal Investigator of the B-AHEAD II Trial, explains that each year, approximately 2 million patients in the US alone sustain head injuries and go to Emergency departments for evaluation.
“Many of these patients present with very mild symptoms, yet may have life-threatening bleeds in the brain. An objective, accurate capability that can rapidly help identify and categorize patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system…” Huff says.
The release reports that the BrainScope Ahead 100 has been developed during 6 years of technology development and clinical studies at hospital Emergency rooms nationwide.
Michael Singer, president and CEO, BrainScope, designates the FDA clearance of Ahead 100 as a “major achievement in BrainScope’s mission to create an objective, non-invasive, patient-friendly assessment device for rapid and easy use in emergency settings. We are particularly grateful for the continuing strong partnership with the Department of Defense. Given our extensive clinical studies, we have maintained long-term relationships with many clinical sites, for which we are appreciative. Lastly, I would like to extend a special thank you to our employees who have worked tirelessly to achieve this milestone, and to their families who have supported them.”
The release also notes that BrainScope recently completed development of a prototype miniaturized Ahead system using existing smartphone technology that will be used for all future development activities. During the month of September, BrainScope announced that it had been awarded three contracts valued at $15.93 million by the US 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 Emergency Departments, and further its traumatic brain injury (TBI) focus to concussion assessment technology with clinical studies in cooperation with university sports programs.