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Regulatory Focus™ > News Articles > 2019 > 4 > FDA Approves First Pediatric ADHD Device

FDA Approves First Pediatric ADHD Device

Posted 22 April 2019 | By Ana Mulero 

FDA Approves First Pediatric ADHD Device

The US Food and Drug Administration (FDA) granted marketing approval to California-based NeuroSigma for the first medical device to be indicated for attention deficit hyperactivity disorder (ADHD) treatment.

The decision to authorize marketing of the Monarch external Trigeminal Nerve Stimulation (eTNS) system was reached and announced last Friday, marking the first approved non-drug ADHD treatment.

The cellphone-sized Monarch eTNS system was evaluated based on NeuroSigma’s July 2018 de novo classification request to FDA’s Center for Devices and Radiological Health (CDRH). It is indicated as a prescription-only device for patients between the ages of seven and 12 who are not currently taking prescription ADHD medication. It can be used at home.

The Monarch eTNS generates low-level electrical stimulation and delivers a tingling sensation on the skin as treatment to the trigeminal nerve via a wire connected to a small patch adhered to the patient’s forehead. Treatment is delivered by increasing activity in brain regions believed to be involved in ADHD.

“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,” says CDRH neurological and physical medicine devices division director Carlos Peña.

The agency clarifies that the device should not be used for patients younger than 7 years of age or for those with active implantable pacemakers, active implantable neurostimulators or body-worn devices such as insulin pumps. It should not be used in the presence of radio frequency energy either.

The move marks the third de novo CDRH has granted just this month. This is in line with the trend seen in granted requests, which have been steadily increasing in recent years for more low- to moderate-risk new device types. CDRH reported on the growing body of de novo pediatric approvals during a public workshop last August.

CDRH chief medical officer for pediatrics and special populations Vasum Peiris recently highlighted new work to create a pediatric medical devices innovation safety net like the new National Evaluation System for health Technology. “It is very reassuring to see that there is potential for the concept, especially because it makes a difference in the health and wellbeing of children,” Peiris previously told Focus.


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