Monarch eTNS System gets marketing authorisation for ADHD

The FDA has granted NeuroSigma marketing authorisation for the Monarch external Trigeminal Nerve Stimulation System, the first medical device to treat attention deficit hyperactivity disorder.
The prescription-only, cell-phone sized device is only for patients ages 7 to12 years old who are not currently taking prescription ADHD medication. A wire connects to a small patch that is placed just above the eyebrows, and delivers a low-level electrical pulse to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. Efficacy of the system was shown in a clinical trial that compared eTNS as the sole treatment to a placebo device where patients using the eTNS device had statistically significant improvement in their ADHD symptoms versus the placebo group. No serious adverse events were associated with use of the device.
Carlos Peña, Ph.D., 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 pediatric patients through the use of mild nerve stimulation, a first of its kind.” (The FDA’s) action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”