The U.S. Food and Drug Administration Monday allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder 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.
The device, the Neuropsychiatric EEG-Based Assessment Aid System, is based on electroencephalogram technology, which records different kinds of electrical impulses given off by neurons in the brain and the number of times the impulses are given off each second.
The NEBA System is a 15- to 20-minute non-invasive test that calculates the ratio of two standard brain wave frequencies, known as 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.
“Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “The NEBA System along with other clinical information may help health care providers more accurately determine if ADHD is the cause of a behavioral problem.”
ADHD is one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, nine percent of U.S. adolescents have ADHD and the average age of diagnosis is 7 years old. Children with ADHD have difficulty with attention, hyperactivity, impulsivity and behavioral problems.
NEBA Health of Augusta, Ga., manufactures the NEBA System.