FDA Permits Marketing of Brain Device

FDA allows marketing of the first medical device based on brain function to assess Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents 6 to 17 years old. ADHD is one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, nine percent of adolescents in the U.S have ADHD.

When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis, or confirm a clinician’s decision that further diagnostic testing is needed on ADHD, or that other medical or behavioral conditions are producing symptoms similar to ADHD.

The device, the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System is based on EEG technology which records different kinds of electrical impulses given off by neurons in the brain and reports on the number of times the impulses are given off each second.

The NEBA System is a 15 to 20 minute noninvasive test that can calculate 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.

NEBA Health of Augusta Georgia, manufactures the NEBA System. To receive FDA approval, the manufacturer submitted data including a clinical study that evaluated 275 children and adolescents ranging from 6 to 17 years old with attention or behavioral concerns.

Clinicians evaluated all 275 patients using the NEBA System and used standard diagnostic protocols to determine if the patient had ADHD. An independent group of ADHD experts reviewed the data and arrived at a consensus diagnosis as to whether the research subject met the clinical criteria for ADHD or for another condition.

The study results showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD as compared to just doing a clinical assessment.

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