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.
Read More