FDA Clears First Device for Treatment of ADHD

On Friday, the Food and Drug Administration (FDA) announced that it is permitting the marketing of the first medical device for the treatment of attention-deficit/hyperactivity disorder (ADHD). The device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, will be available by prescription only and is indicated for children aged 7 to 12 years who are not taking prescription ADHD medications.“This new device offers a safe, nondrug 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 FDA’s Division of Neurological and Physical Medicine Devices, in the agencypress 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 eTNS System delivers low-level electrical pulses to a child ’s trigeminal nerve while the child sleeps via wires and a small patch adhered to the child’s forehead. The exact mechanism of eTNS is not yet known, but neuroimaging studies have shown that the trigeminal nerve connects to brain regions that are important in regulating attention, emotion, and b ehavior.The efficacy of the Monarch system was shown in a recently published clinical trial of 62 children with ADHD. The participants randomly received either eTNS...
Source: Psychiatr News - Category: Psychiatry Tags: ADHD attention-deficit/hyperactivity disorder child and adolescent psychiatry FDA FDA approval Food and Drug Administration medical device neuromodulation TNS Trigeminal nerve stimulation Source Type: research