FDA OKs First Medical Device to Treat ADHD in Children

DThe first medical device to treat childhood attention deficit hyperactivity disorder, or ADHD, was OK’d Friday by the US Food and Drug Administration. Designated for children ages 7 to 12 who are not currently on medication for the disorder, the device delivers a low-level electrical pulse to the parts of the brain responsible for ADHD symptoms.

“This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind,” Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.

Called the Monarch external Trigeminal Nerve Stimulation System, eTNS,and marketed by NeuroSigma, the treatment is only available by prescription and must be monitored by a caregiver.

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