FDA approves first medical device ADHD treatment

US regulators have given the green-light for the first medical device to treat attention deficit hyperactivity disorder (ADHD). NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the Food and Drug Administration (FDA) and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. It’s a mobile phone sized device that generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient’s forehead and delivers a low-level electrical stimulation that should feel like a tingling sensation on the skin. Carlos Peña, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said: “This new device offers a safe, non-drug option for treatment of ADHD in paediatric patients through the use of mild nerve stimulation, a first of its kind.