FDA clears second-generation Monarch eTNS System for treating pediatric ADHD

The FDA has cleared NeuroSigma’s second-generation Monarch eTNS System for treating pediatric ADHD. The device is smaller and includes a high-resolution color LCD screen and optimized user interface. It is indicated for patients aged 7 to 12 years who are not currently taking ADHD medications. NeuroSigma plans to scale its commercial operations to help treat the millions of children in the U.S. and worldwide suffering from ADHD. The device is also expected to serve as a hub for NeuroSigma’s planned digital health platform.

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