BrainScope has announced that the United States Food and Drug Administration (FDA) has cleared the company’s Ahead 100 device through the de novo classification process. The Ahead 100 uses a patient’s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain after head injury.
It is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head computerised tomography (CT) scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury, and are between the ages of 18-80 years.
“Each year there are approximately two million patients in the United States alone who sustain head injuries and go to Emergency Departments for evaluation,” states J 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. “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 categorise patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system. The performance and clinical utility of the Ahead 100 is superior to that of standard of practice tools. Also, the possibility of reduction of use of neuroimaging in patients with head injury is consistent with the Choosing Wisely campaign sponsored by several professional organisations.”
“This is a landmark event in the assessment of head injury,” adds Daniel Hanley, the Jeffrey & Harriet Legum professor of Acute Care Neurology at Johns Hopkins University, director of the Johns Hopkins Brain Injury Outcomes Services division, and Medical Advisory Board member to BrainScope. “I am greatly impressed by the performance of the Ahead 100 for discriminating clinically important mild traumatic brain injury and believe this device is a practical, safe and transformative adjunct to acute CT scan.”
The BrainScope Ahead 100 has been developed over six years of technology development and clinical studies at hospital Emergency Rooms across the USA, creating an extensive database of head injured patients. “Using sophisticated classification algorithm methods we sought neurophysiological profiles or signatures of changes in brain electrical activity associated with traumatic structural brain injury,” explains Leslie Prichep, director of the Quantitative Neurophysiological Brain Research Laboratories at the NYU School of Medicine and consultant to BrainScope. “One of the most important findings was the extremely high performance of the Ahead 100 to identify the absence of structural brain injury after a patient has sustained a head injury. This provides important information to the clinician, contributing to a rule-out for one of the most prevalent concerns clinicians have with mildly presenting patients.”