FDA Approves Marketing Of Monarch eTNS System, First Medical Device For ADHD

On April 19, 2019, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the Monarch eTNS System to NeuroSigma; the system is the first medical device to treat attention deficit hyperactivity disorder (ADHD). According to Leon Ekchian, president and chief executive officer at NeuroSigma, in the United States, the prescription-only Monarch device is indicated for treatment of pediatric ADHD as a monotherapy in children ages seven through 12 years old who are not currently taking prescription ADHD medications.  The device is intended to be used in the home under the supervision of a caregiver during periods . . .