FDA allowed marketing of the first diagnostic device based on brain function
Leo Sher, M.D.
The U.S. Food and Drug Administration permitted marketing of the first device based on brain function to help diagnose attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. The device can help establish an ADHD diagnosis. It should be used as part of a complete medical and psychological evaluation.
The device, the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is based on electroencephalogram (EEG) technology, which records waves produced by neurons in the brain and the number of times (frequency) the impulses are produced each second.The NEBA System is a 15- to 20-minute non-invasive test that calculates the ratio of theta and beta waves. The theta/beta ratio has been shown to be higher in children and adolescents with ADHD than in children without it.
ADHD is considered to be a neurobiological disorder that interferes with a person’s ability to sustain attention or focus on a task and to control impulsive behavior. Children with ADHD have difficulty with attention, hyperactivity, impulsivity and behavioral problems. ADHD affects about 5% to 10% of the children, with boys being affected about two to four times more than girls.