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First medical device to treat ADHD in children approved by FDA

Posted on April 22, 2019 by Medtech[y] Staff


The FDA has approved marketing authorization of the first medical device to treat attention deficit hyperactivity disorder (ADHD) in children. The device was developed by NeuroSigma and is called the Monarch eTNS System.

The device is indicated for patients ages 7 to 12 years old who are not currently taking prescription ADHD medication and has to be prescribed by an authorized physician. The approval came after the FDA review the Monarch eTNS System through the de novo premarket review pathway.

“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,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

Learn about the Monarch eTNS System


The device is the size of a cell-phone and generates low-level electrical pulses by connecting a wire to a small patch that adheres to a patient's forehead. The pulses feel like a tingling sensation on the skin and deliver low-level 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 isn't known, neuroimaging studies have shown that the device increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.

In a clinical trial, 62 children with ADHD were given either the Monarch eTNS System as a sole treatment or a placebo device with the primary endpoint to improve on a clinician-administered ADHD rating scale. The trial showed that patients using eTNS device had statistically significant improvement in their ADHD symptoms compared with the placebo group. At the end of week four, the average ADHD-RS score in the active group decreased from 34.1 points at baseline to 23.4 points, versus a decrease from 33.7 to 27.5 points in the placebo group.

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