First Brain Wave Test Approved For ADHD By FDA

Posted by Phillipa on July 15, 2013, at 21:18:50

For children 6-17 years of age.

FDA Approvals > Medscape Medical News
First Brain-Wave Test for ADHD Approved by FDA
Robert Lowes
DisclosuresJul 15, 2013

Drug & Reference Information
Attention Deficit Hyperactivity Disorder
Reading Learning Disorder
Pervasive Developmental Disorder

The US Food and Drug Administration (FDA) today approved the first brain-wave test to help diagnose attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years, the agency announced.
The testing device is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System. The noninvasive test, based on electroencephalogram technology, computes 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.
Together with a complete medical and psychological workup, the NEBA System can help confirm a diagnosis of ADHD or a decision to focus further testing on ADHD or other conditions with similar symptoms, according to the FDA.
"The NEBA System along with other clinical information may help healthcare providers more accurately determine if ADHD is the cause of a behavioral problem," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a news release.

Information from Industry
The agency based its decision to approve the NEBA System in part on a clinical study of 275 children and adolescents with attention or behavioral issues. Clinicians evaluated all of them using the new brain-wave test along with standard diagnostic protocols and physical exams. An independent panel of ADHD experts reviewed the findings to determine whether each patient satisfied the criteria for ADHD or another condition. The study showed that adding the brain-wave test to a clinical assessment helped clinicians make a more accurate ADHD diagnosis than if they had performed only the clinical assessment.
The NEBA System is made by NEBA Health, in Augusta, Georgia.
More information on the FDA decision to approve the NEBA System is available on the agency Web site.

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