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FDA Approves Digital Health Treatment for Children Living With ADHD

The FDA has the given the OK to a digital therapeutic platform that aims to help children ages 7-12 who are living with ADHD. The mHealth device delivers directed doses of energy to the brain through a wearable patch while the child is sleeping.

Source: ThinkStock

By Eric Wicklund

- Federal regulators have OK’d an mHealth device aimed at improving care management for children with attention deficit hyperactivity disorder (ADHD).

The US Food and Drug Administration has permitted marketing of NeuroSigma’s Monarch external Trigeminal Nerve Stimulation (eTNS) System, a digital health device, about the size of a smartphone, that sends targeted, low-level electrical pulses through a wearable patch into the brain during sleep.

The prescription-only digital therapeutic treatment is designed for children ages 7-12, and aimed at replacing ADHD medication and, in effect, training their brains to deal with attention, emotion and behavior.

“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,” Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press 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.”

Designed to be worn at night under the supervision of a caregiver, the mobile health platform delivers low-level bursts of electricity through the forehead and into the trigeminal nerve, which sends signals to the parts of the brain thought to be involved in ADHD.

The FDA’s action was based on a clinical trial involving some 62 children. After four weeks of use, the children using the eTNS platform showed “statistically significant improvement in their ADHD symptoms” compared to a placebo device.

According to the FDA, the Monarch eTNS System was reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. “This action creates a new regulatory classification,” the agency said, “which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

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