Firefly and NeuroSigma Team Up to Promote ADHD Treatment Device
Firefly Neuroscience and NeuroSigma have partnered to introduce NeuroSigma's Monarch eTNS System to clinicians using Firefly's Evoke platform. Firefly will handle clinician education, while NeuroSigma provides training, prescribing support, and specialty-pharmacy fulfillment. Monarch is FDA-cleared for pediatric ADHD in children aged 7-12 who are not on prescription medication.
The partnership pairs NeuroSigma's Monarch device with Firefly's Evoke platform, which uses FDA 510(k)-cleared EEG/ERP assessment technology. Monarch delivers mild external trigeminal nerve stimulation during sleep, offering a non-drug alternative for children aged 7 to 12 with ADHD who are not currently taking prescription medication.
NeuroSigma launched the second-generation Monarch in July 2026, following a waitlist exceeding 1,500 patients, caregivers, and healthcare providers. Firefly separately reported potential ADHD-related EEG/ERP biomarkers in March 2026, though those findings remain unvalidated and require additional research.
This partnership could expand access to a non-pharmaceutical ADHD treatment option for families seeking alternatives to medication, particularly for younger children. If the device gains broader adoption, it may shift how some clinicians approach pediatric ADHD care, potentially reducing reliance on prescription drugs. However, the biomarker findings remain preliminary, and wider impact will depend on clinical validation, insurance coverage, and physician acceptance. Families and healthcare providers may benefit from additional treatment choices, though outcomes will vary by individual patient circumstances.