For the first time, the US Food and Drug Administration has approved the first device based on brain function (and made by Neba Health) to help assess attention-deficit hyperactivity disorder.
The device is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System and is based on electroencephalogram technology, which records different kinds of electrical impulses given off by neurons in the brain and the number of times the impulses are given off each second.
The NEBA System is a 15- to 20-minute non-invasive test that calculates 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.
Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said that diagnosing ADHD "is a multistep process based on a complete medical and psychiatric exam". She added that the NEBA System "along with other clinical information may help healthcare providers more accurately determine if ADHD is the cause of a behavioural problem".
Neba Health ran a study of 275 children and adolescents between six and 17 with behavioural concerns and found that the device helped doctors make a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment, compared with doing the latter alone.
According to the American Psychiatric Association, 9% of US adolescents have ADHD and the average age of diagnosis is seven years old.