First Medical Device to Treat ADHD in Children Gets FDA OK

By MedTech Intelligence Staff

The non-invasive trigeminal nerve stimulation system is intended for patients seven to 12 years old.

Last week FDA gave its blessing to the first medical device to treat attention deficit hyperactivity disorder (ADHD). Manufactured by NeuroSigma, the Monarch external Trigeminal Nerve Stimulation (eTNS) System is a non-invasive alternative to drug therapy. Approximately the size of a cell phone, the device is intended for home use under caregiver supervision. A wire delivers a low-level electrical pulse into a patch that sticks to the patient’s forehead, stimulating the branches of the trigeminal nerve, sending “therapeutic signals to the parts of the brain thought to be involved in ADHD,” according to an FDA news release. “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,” the agency states.

The device is intended for use during sleep, and it can take up to four weeks to see results.

“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,” said Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in CDRH in the agency news release.“Today’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.”

The Monarch product was reviewed through the de novo premarket review pathway.

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