Monarch Becomes the 1st FDA-Cleared Device for ADHD

The Monarch external Trigeminal Nerve Stimulation (eTNS) System made history last week after it became the first device to win a nod from FDA to treat attention deficit hyperactivity disorder (ADHD). It should be noted the technology has had CE mark since 2015. Monarch was developed by NeuroSigma and is indicated to help treat 7 to 12-year-olds suffering from ADHD. What makes this de novo clearance from FDA so significant is that typically pharmaceutical solutions are used to treat patients suffering from the neurological disorder. Monarch is about the size of a cellphone. The 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, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior. Join us for New England’s Premier Medtech Event Held at the Boston Convention Exhibition Center in Boston, MA, May 15-16. “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 kin...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news

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