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FDA signs off on first medical device for treating ADHD in children

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FDA approves device for ADHD children

As diagnosis rates of ADHD among children skyrocket, a new medical device for the treatment of the disorder could soon be hitting the market.

The U.S. Food and Drug Administration announced Friday that it has permitted marketing for the first medical device to treat ADHD. The authorization has been granted to the life sciences company NeuroSigma Inc. based in Los Angeles.

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

The Monarch eTNS – an instrument the size of a cell phone – is designed for use at home with adult supervision. It connects via wire to a small patch placed on the forehead of the patient, generating a low-level electrical pulse to the brain.

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