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FDA approved device testing brain function to assess for ADHD
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The FDA today approved marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder in children and adolescents aged 6 to 17 years.
The Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is based on encephalogram (EEG) technology. NEBA is a 15 to 20 minutes non-invasive test that calculates the ratio of beta and theta brain wave frequencies. Theta and beta ratios have been shown to be higher in children and adolescents with ADHD compared with those without.
Christy Foreman
“Diagnosing ADHD is a multistep process based on complete medical and psychiatric exam,” Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health said in a press release. “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.”
NEBA was reviewed by the FDA through the de novo classification process. NEBA manufacturers submitted data from a clinical study evaluating 275 children and adolescents aged 6 to 17 years with attention or behavioral concerns. Using NEBA, researchers were able to make a more accurate diagnosis when used along with clinical assessment for ADHD.