FDA permits marketing of first medical device for treatment of ADHD

FDA

19 April 2019 - The U.S. FDA today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder. 

The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug treatment for ADHD granted marketing authorisation by the FDA.

The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The cell-phone sized device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrows, and should feel like a tingling sensation on the skin. 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. While the exact mechanism of eTNS is not yet known, neuro-imaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behaviour.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , US , Device