FDA Permits Marketing of ADHD Treatment Device From NeuroSigma

The FDA permitted marketing of NeuroSigma’s Monarch eTNS System, the first medical device to treat attention deficit hyperactivity disorder (ADHD).

• The prescription-only device, the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to 12 who are not currently taking prescription ADHD medication.
• The cell-phone sized device connects via a wire to a small patch that adheres to a patient’s forehead, delivering a low-level electrical stimulation to the branches of the trigeminal nerve, sending therapeutic signals to parts of the brain thought to be involved in ADHD.
• The FDA reviewed the Monarch eTNS through the de ...