The Ahead 100, which uses an electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain after head injury, has received de novo clearance from the FDA, according to manufacturer BrainScope. The device is not intended to replace CT scans, but 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.

“This is a landmark event in the assessment of head injury,” added Daniel Hanley, MD, 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 was developed over 6 years through technology improvements and clinical studies in emergency departments across the country; this approach allowed the company to create an extensive database of head injured patients. This data was leveraged to develop “sophisticated classification algorithm methods” to identify “neurophysiological profiles or signatures of changes in brain electrical activity associated with traumatic structural brain injury,” according to Leslie S. Prichep, PhD, director of the Quantitative Neurophysiological Brain Research Laboratories at the NYU School of Medicine and consultant to BrainScope.