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Medical Devices / Submissions and Approvals

FDA Allows Marketing of ADHD Treatment Device

April 23, 2019
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The FDA has given a green light for NeuroSigma’s Monarch external Trigeminal Nerve Stimulation (eTNS) system, a non-drug treatment for pediatric patients with ADHD.

The cell-phone sized device generates a low-level electrical pulse and is attached, by wire, to a small patch on the patient’s forehead. It is designed for home use under caregiver supervision.

The system is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication.

It is the first non-drug treatment for ADHD granted marketing authorization by the FDA. The system gained the CE Mark in November 2015.

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