FDA permits marketing of first brain wave test to help assess children and teens for ADHD
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 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions that produce symptoms similar to ADHD.
The test uses an electroencephalogram, or EEG, with sensors attached to a child’s head and hooked by wires to a computer to measure brain waves. It traces different types of electrical impulses given off by nerve cells in the brain and records how many times those impulses are given off each second.
The test takes 15 to 20 minutes, and measures two kinds of brain waves — theta and beta. Certain combinations of those waves tend to be more prevalent in children with A.D.H.D., the Food and Drug Administration said in a news release.