July 16 (Bloomberg) -- The first medical device to help doctors diagnose attention-deficit hyperactivity disorder by scanning brain waves was cleared for sale by U.S. regulators.
Neba Health’s EEG-based assessment system for children ages 6 to 17 years old takes about 20 minutes and records the number of times brain waves are given off each second. It’s designed to be used jointly with a doctor’s clinical assessment, the Food and Drug Administration said yesterday in a statement.
ADHD, which causes inattentiveness, over-activity and impulsiveness, is one of the most common mental disorders in children, affecting 9 percent of adolescents, according to the American Psychiatric Association. The ratio of the two standard brain waves, theta and beta, is higher in children with ADHD, the FDA said in announcing its approval.
“Diagnosing ADHD is a multistep process based on a 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 the statement. “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, based in Augusta, Georgia, is closely held. The device was cleared using the FDA’s de novo process for low- to moderate-risk devices that is less rigorous than the regular approval system. Neba tested the device in 275 patients and found it helped better diagnose ADHD than clinical assessment alone, the FDA said.
While the cause of ADHD is unknown, a combination of environmental and genetic factors have been singled out by some researchers as possible contributors.
Medicines for ADHD include amphetamines like Shire Plc’s Adderall XR, as well as other drugs like Novartis AG’s Ritalin, Johnson & Johnson’s Concerta, Shire’s Vyvanse and Intuniv and Eli Lilly & Co.’s Strattera. Treatments also include parent and child education, behavior management and counseling.
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