FDA permits marketing of first brain wave test to help assess children and teens for ADHD

View Article on the FDA Press Archives FDA NEWS RELEASE For Immediate Release: July 15, 2013 Media Inquiries: Synim Rivers, 301-796-8729, synim.rivers@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to […]

De Novo Classification Request For Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) System

The Neuropsychiatric Interpretive Electroencephalograph Assessment Aid is a prescription device that uses a patient’s electroencephalograph (EEG) to provide an interpretation of the patient’s neuropsychiatric condition. The Neuropsychiatric Interpretive EEG Assessment Aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. Download PDF on FDA.gov