Monarch Becomes the 1st FDA-Cleared Device for ADHD

NeuroSigma’s Monarch eTNS might be the first device to treat ADHD, but it is one of a growing number of technologies that occupy the burgeoning bioelectronic medicine space. 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.