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US FDA Grants Marketing Approval for Device to Treat ADHD

April 22, 2019

By Reuters Staff

The U.S. Food and Drug Administration on Friday granted marketing approval for the first medical device to treat attention deficit hyperactivity disorder (ADHD).

The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for children ages 7 to 12 who are not currently taking prescription ADHD medication.

According to a statement from the FDA, the cell-phone sized device is intended to be used at home under the supervision of a caregiver. The device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead. The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD.

Clinical trials suggest that a response to eTNS may take up to four weeks to become evident.

The device, marketed by NeuroSigma, is already approved for children with ADHD in Europe.

More information is available from the FDA here:

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