FDA Approves Brain Function Device to Assess ADHD


The US Food and Drug Administration today has allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents between the ages of 6 and 17.

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.

How the device works

The device is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System. Made by NEBA Health of Augusta, Georgia, it is based on electroencephalogram (EEG) technology, which records different kinds of electrical impulses (waves) given off by neurons (nerve cells) in the brain and the number of times (frequency) the impulses are given off each second.

The NEBA System itself is a non-invasive test that requires between 15 and 20 minutes to conduct. The test 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.

Said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health:

Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam. 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.

Among the most common neurobehavioral disorders in childhood, ADHD affects as much as 9 percent of the adolescent population in the U.S., according to the American Psychiatric Association.

Source: FDA

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