FDA Approves First Device to Treat Children With ADHD

The first medical device to treat children with attention-deficit/hyperactivity disorder (ADHD) has been approved by the U.S. Food and Drug Administration.

The device delivers a low-level electrical pulse to areas of the brain linked with ADHD symptoms and is approved for treatment of children aged 7 to 12 who are not on medication for ADHD, CNN reported.

Treatment with NeuroSigma's Monarch external Trigeminal Nerve Stimulation System (eTNS) is by prescription and must be monitored by a caregiver.

"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 Pena, director of the FDA's Division of Neurological and Physical Medicine Devices, said in a statement.

The pocket-sized device is for use at home while a child is sleeping. It's connected by wire to a small patch placed on the child's forehead above the eyebrows, CNN reported.

In a clinical trial of 62 children, those who used the device had statistically significant improvements in their ADHD symptoms, compared to those who received a placebo, according to the FDA.

NeuroSigma's website says the device is not currently covered by insurance and could cost just over $1,000 for the starter kit, CNN reported.

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