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FDA clears use of EEG-based ADHD test

human-brain-biometricsFirst ADHD brain wave test approved by FDA (CBS News):

“Diagnosing someone with attention deficit hyperactivity disorder (ADHD) is often a tricky science because it relies heavily on psychiatric and behavioral examinations. For the first time, the Food and Drug Administration has approved a device that could aid doctors by providing physical evidence for diagnosis…The Neuropsychiatric EEG-Based Assessment Aid (NEBA) System is the first medical device of its kind to help diagnose the neurobehavioral disorder in children and teens. It uses an electroencephalogram (EEG) test to look at the patient’s brain waves.”

FDA announcement, FDA permits marketing of first brain wave test to help assess children and teens for ADHD:

“The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions that produce symptoms similar to ADHD…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…The FDA reviewed the NEBA System through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.”

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Categories: Attention and ADD/ADHD, Cognitive Neuroscience, Health & Wellness, Technology

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