FDA Allows Marketing of ADHD Treatment Device
The FDA has given a green light for NeuroSigma’s Monarch external Trigeminal Nerve Stimulation (eTNS) system, a non-drug treatment for pediatric patients with ADHD.
The cell-phone sized device generates a low-level electrical pulse and is attached, by wire, to a small patch on the patient’s forehead. It is designed for home use under caregiver supervision.
The system is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication.
It is the first non-drug treatment for ADHD granted marketing authorization by the FDA. The system gained the CE Mark in November 2015.