NeuroSigma today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its second-generation Monarch eTNS System (Monarch 2.0).

The Monarch eTNS System was the first-ever wearable medical device to receive FDA clearance as a treatment for pediatric ADHD, and the 510(k) submission is the first step in the FDA review process to obtain clearance for Monarch 2.0.

Compared to the first-generation Monarch eTNS System, Monarch 2.0 has a smaller form factor, streamlined user interface, and an improved, longer duration battery. Once cleared, the Monarch 2.0 will also serve as the foundation for NeuroSigma’s proprietary digital health platform.

“Submission of the 510(k) for Monarch 2.0 is an important milestone for NeuroSigma and we look forward to working with FDA to obtain clearance,” said Colin Kealey, M.D., President and CEO of NeuroSigma. “The Monarch 2.0 is a critical part of NeuroSigma’s global corporate strategy, and will allow us to achieve the scale necessary to deliver safe and reliable trigeminal nerve stimulation therapy to the millions of patients worldwide suffering from ADHD.”

Source: Company Press Release