FDA Tick and Progress for Paediatric ADHD NeuroStim Device

Image credit: NeuroSigma

US-based NeuroSigma is finalising trial participants for its second-generation Monarch external trigeminal nerve stimulation (eTNS) system, indicated for use in treating attention deficit hyperactivity disorder (ADHD) in children.

Last month saw the ground-breaking device get a greenlight from the US Food and Drug Administration (FDA), a first for devices relating to paediatric ADHD.

Developed as an alternative treatment for children aged seven to 12 with ADHD and not currently using prescription medications, the Monarch system delivers small electrical impulses to the trigeminal cranial nerve which is associated with sensory function.

“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 US and worldwide suffering from ADHD,” said NeuroSigma President and CEO, Dr Colin Kealey.

“We believe that data from these trials [commencing in 2024] will definitively establish the role of eTNS for the treatment of ADHD and further accelerate commercial adoption and payer coverage of this innovative treatment.”

By the end of 2024, the company anticipates 375 subjects will be enrolled in its two clinical trials across the US and UK.

Read the full announcement from NeuroSigma for further details regarding FDA approval of the device.