Firefly, NeuroSigma partner to expand access to first FDA-cleared pediatric ADHD treatment

  • Firefly and NeuroSigma partnered to introduce Monarch through Evoke-using clinical practices.
  • AIFF shares rose 42.01% to $1.68 at the time of publication.
  • NeuroSigma began U.S. sales in July 2026 after a waitlist exceeding 1,500 people.

Firefly Neuroscience (NASDAQ: AIFF) and NeuroSigma have partnered to expand clinician awareness of and access to NeuroSigma’s second-generation Monarch eTNS System through practices using Firefly’s FDA 510(k)-cleared Evoke platform. Firefly will introduce the prescription-only, non-drug pediatric ADHD therapy to psychiatry, neurology and behavioral-health practices, while NeuroSigma will provide clinical training, prescribing support and fulfillment through a specialty pharmacy. Monarch is cleared by the U.S. Food and Drug Administration as a monotherapy for children ages 7 through 12 with ADHD who are not taking prescription ADHD drugs. The palm-sized device delivers mild external trigeminal nerve stimulation through a forehead patch while the child sleeps. Firefly’s Evoke platform combines quantitative EEG and ERP testing with AI analytics and a database of more than 200,000 brain scans. In March 2026, the company identified EEG/ERP biomarkers that may help distinguish the three ADHD presentations and support treatment selection and monitoring, subject to further research and validation. A 2024 study estimated that approximately 7.1 million U.S. children had received an ADHD diagnosis and that nearly one-third of the estimated 6.5 million children with current ADHD received no specific treatment. NeuroSigma began U.S. sales of the second-generation Monarch device in July 2026 after a waitlist of more than 1,500 patients, caregivers and healthcare providers, and expanded third-party installment payment options in September. Firefly shares were up 42.01% at $1.68 at the time of publication, according to Benzinga Pro data.

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