(WASHINGTON) -- The U.S. Food and Drug Administration announced Monday that it would allow marketing for the NEBA System, the first-ever medical device based on brain function that will help to asses attention-deficit/hyperactivity disorder (ADHD) in children ages 6 to 17 years old.
The Neuropsychiatric EEG-Based Assessment Aid, or NEBA, is a 15 to 20 minute test that calculates the ratio of theta and beta waves in the brain. The theta/beta ratio has been typically shown to be higher in children and adolescents with ADHD than in children without the disorder.
But the test's results alone would not be the determining factor for whether or not a child has ADHD, according to the FDA.
“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.”
When used during a complete medical and psychological examination, the FDA says NEBA can help to confirm an ADHD diagnosis or decisions about whether further diagnostic testing is necessary.
According to the the American Psychiatric Association, ADHD is one of the most common neurobehavioral disorders to occur in children, with nine percent of U.S. adolescents having ADHD and the average age of diagnosis being at 7 years old.
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