NeuroSigma will sell its Monarch eTNS system into psychiatry, neurology and behavioral health practices through Firefly Neuroscience's customer base. The two companies announced the agreement on September 25. Terms were not disclosed.
Monarch is the first non-drug ADHD treatment FDA cleared. The label is monotherapy for children 7 to 12 who are not on prescription medication. A palm-sized generator drives trigeminal nerve stimulation through an adhesive forehead patch worn during sleep.
NeuroSigma shipped the second-generation unit in July 2026 after a waitlist of 1,500 built up, and added third-party installment payment plans this month. Firefly's Evoke platform is 510(k) cleared and pairs quantitative EEG and event-related potential testing with analytics trained on more than 200,000 brain scans. Firefly makes the introduction, NeuroSigma handles training and fulfillment.
A waitlist and an installment plan tell you where the friction sits. Monarch's clearance is old news; putting the device in clinics and getting families to pay for it is the open problem, and renting someone else's installed base is a cheaper answer than building a sales force.