USA Today (4/20, Garrison) reported that on Friday, the FDA “announced…that it permitted marketing for the first medical device to treat” attention-deficit/hyperactivity disorder (AD/HD). Known as “the Monarch external Trigeminal Nerve Stimulation (eTNS) System, the prescription-only device is for children ages 7 to 12 who are not taking…prescription medication” for the disorder. In a statement, 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” AD/HD “in pediatric patients through the use of mild nerve stimulation, a first of its kind.”
CNN (4/20, Lamotte) reported that “the device should not be worn by children under the age of seven, or any child on an insulin pump, pacemaker or implanted neurostimulator.” The device “should also not be used near a cell phone, the FDA said, because the phone’s low levels of electromagnetic energy may interrupt the therapy.”
The Hill (4/20, Axelrod) reported that “eTNS, which is designed to fit inside one’s pocket, is connected by wire to a patch that is placed on the forehead while sleeping and delivers a “tingling” electrical impulse to branches of the trigeminal nerve.” The FDA said, “While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior.”
Related Links:
— “FDA signs off on first medical device for treating ADHD in children, “Joey Garrison, USA Today, April 20, 2019