FDA Clears NeuroSigmas’s Second Generation Monarch External Trigeminal Nerve Stimulation System For Pediatric ADHD  

NeuroSigma said the FDA granted clearance for the use of its second-generation Monarch external trigeminal nerve stimulation (eTNS) System for treating pediatric attention deficit hyperactivity disorder (ADHD). Monarch 2.0 is indicated for treating pediatric ADHD as a monotherapy for consumers aged 7 to 12 years old who are not taking prescription ADHD medications.  

The Monarch eTNS device is intended for home use during sleep. The system consists of a controller device the size of a mobile phone and disposable patches that connect to the device. The patch is placed on the child’s forehead, where the trigeminal nerve . . .