First Medical Device to Help Diagnose ADHD Approved
TUESDAY, July 16 -- The first medical device designed to help medical professionals diagnose attention deficit/hyperactivity disorder (ADHD) in children and teens has been approved by the U.S. Food and Drug Administration.
The Neuropsychiatric EEG-Based Assessment Aid (NEBA) records and analyzes electric impulses produced by the brain's nerve cells, the agency said in a news release. The non-invasive device, which takes about 20 minutes to produce complete results, measures brain wave frequencies called theta and beta waves. The theta/beta ratio has been shown to be higher in young people with ADHD, the FDA said.
Citing the American Psychiatric Association, the FDA said about 9 percent of U.S. adolescents have ADHD, and the average age of diagnosis is 7 years. Children with ADHD typically have behavior problems, trouble paying attention and hyperactivity.
Device maker NEBA Health submitted data from a clinical study of 275 children and adolescents, ranging in age from 6 to 17. The study found that the new device helped professionals better diagnose children with ADHD when combined with a psychological assessment, compared to a psychological assessment alone.
NEBA is based in Augusta, Ga.
The U.S. Centers for Disease Control and Prevention has more about ADHD.
Posted: July 2013