The First ADHD Medical Device For Children

The U.S. Food and Drug Administration announced Friday that it has permitted marketing for the first medical device to treat ADHD. As diagnosis rates of ADHD among children skyrocket, a new medical device for the treatment of the disorder could soon be hitting the market.

Called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, the prescription-only device is for children ages 7 to 12 who are not currently taking ADHD prescription medication.

Diagnosis rates for ADHD have risen 30% in 8 years. "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.”

ADHD, a common and growing disorder that begins in childhood, includes difficulty staying focused and paying attention, difficulty controlling behavior and very high levels of activity. Symptoms of ADHD must be long-lasting, impair the person's functioning and cause the person to fall behind normal development for his or her age.

The device should not be used for children under 7 years old, the FDA says, or among patients with an active implantable peacemaker, active implantable neurostimulators or body-worn devices such as insulin pumps.

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