FDA approves NEBA System (Neba Health) for diagnosing ADHD

The FDA has approved the use of the NEBA System, from Neba Health, to help assess Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents 6 to 17 years old. The Neuropsychiatric EEG-Based Assessment Aid or NEBA System is a noninvasive test based on electroencephalogram technology. It is designed to compute the ratio of theta and beta brain waves in 15 to 20 minutes. Children and adolescents with ADHD have a higher theta-beta ratio than those who do not have the disorder.

Approval is based on 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 using standard diagnostic protocols and showed that the use of the NEBA System aided a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment.