A small Georgia company won the FDA's blessing this week to start marketing the first medical device of its kind approved to help diagnose attention-deficit/hyperactivity disorder, or ADHD.
NEBA Health in Augusta had spent 7 years developing its Neuropsychiatric EEG-Based Assessment Aid (NEBA) system, The Augusta Chronicle reports. It is designed to aid ADHD diagnosis along with a medical and psychiatric exam.
Regulators caution that the test should be part of a multistep diagnostic process. ADHD symptoms include having a hard time paying attention, plus trouble focusing or controlling one's behavior. But the symptoms can be part of other disorders, according to National Institute of Mental Health data cited by The Augusta Chronicle. Some experts argue that ADHD is overused as a diagnosis.
The FDA ultimately backed the company's de novo petition, based in part on a study of 275 children and adolescents that concluded the test gave a more accurate diagnosis when used along with a clinical assessment than just clinical assessment alone (which can include a psychiatric test, behavioral questionnaire, behavioral and IQ testing and medical exams). Outside ADHD experts evaluated the results. In all, NEBA Health pursued four large clinical trials, The Augusta Chronicle said.
Approval of the test creates a profound market opportunity for NEBA, considering that ADHD is one of the most common conditions diagnosed in children. A whopping 9% of U.S. teens have ADHD, and they are generally diagnosed at age 7, according to the American Psychiatric Association. Other rivals are trying to hit the same market. Biobehavioral Diagnostics, or BioBDx, for example, is developing a computer diagnostic tool for ADHD.
The NEBA test is based on electroencephalogram, or EEG, diagnostic technology. It's noninvasive, lasts 15 to 20 minutes and is designed to measure theta and beta brain waves via sensors attached to the child's head. FDA officials in the release announcing the approval note that both brain frequencies are at higher levels in children and teens with ADHD.
But NEBA Health's journey isn't over yet. The next step will be to promote use of the test and gain insurer approval for reimbursement.
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