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

Key takeaways:

• The FDA cleared the use of NeuroSigma’s second-generation Monarch eTNS System for treating pediatric ADHD.
• The device is indicated for patients aged 7 to 12 years who are not currently taking ADHD medications.

The FDA has cleared NeuroSigma’s second-generation Monarch eTNS System for treatment of pediatric ADHD, the company announced in a press release.

The Monarch 2.0 device is approximately one-third the size of the first-generation Monarch eTNS System and includes a high-resolution color LCD screen and optimized user interface. It is indicated as a monotherapy for patients aged 7 to 12 years who are not currently taking prescription ADHD medications, according to the release.

“In 2023, NeuroSigma executed on the first part of its commercial rollout by introducing patients, families and physicians across the United States to eTNS [external trigeminal nerve stimulation] therapy,” Colin P. Kealey, MD, NeuroSigma president and CEO, said in the release. “With FDA clearance and a mid-year launch of Monarch 2.0, we can begin scaling our 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, the company stated.