First Non-Drug Treatment Approved by FDA for Treating Children With ADHD

Topics: ADHD | adolescents | Attention Deficit Hyperactivity Disorder | Brain Devices | Child Psychiatry | children | efficacy | eTNS | News of Note | pediatric | safety | teens | treatment | Trigeminal Nerve Stimulation

NeuroSigma made a splash by announcing that the FDA has granted medical device approval for its external Monarch Trigeminal Nerve Stimulation (eTNS) System for treating kids with ADHD ages 7–12 who are not currently taking medications. What does medical device approval mean? The FDA reviewed the Monarch eTNS System through the de novo ­pre-market