DENVER, Colo. (247marketnews.com) -- Firefly Neuroscience (NASDAQ:AIFF) is moving deeper into pediatric ADHD care through a strategic partnership with NeuroSigma, bringing NeuroSigma’s Monarch eTNS System to Firefly’s nationwide network of clinicians using its Evoke brain-function platform. The deal connects two distinct pieces of the treatment equation: Firefly’s AI-powered EEG/ERP technology for objectively assessing brain activity and Monarch, an FDA-cleared, prescription-only, non-drug treatment for children ages 7 through 12 who are not taking prescription ADHD medication.
The FDA originally authorized the Monarch eTNS System in 2019 as the first non-drug medical-device treatment for ADHD, and the agency says clinical testing showed statistically significant improvement in ADHD symptoms compared with a placebo device. The second-generation Monarch system subsequently received 510(k) clearance in January 2024. It is designed for home use during sleep, delivering mild electrical stimulation to the trigeminal nerve through a forehead patch.
For Firefly, the bigger opportunity is potentially the combination of measurement and intervention. The company says its Evoke platform incorporates qEEG and event-related-potential testing and draws on a database exceeding 200,000 EEG/ERP brain scans. Firefly has also reported research identifying EEG/ERP biomarkers that may help distinguish among ADHD presentations, although those findings remain subject to further research and validation. CEO Greg Lipschitz called the new partnership “an important step toward a more objective and personalized approach to pediatric ADHD care,” emphasizing the combination of brain-function measurement with additional treatment options.
NeuroSigma, meanwhile, gains access to an established network of clinicians already using a brain-assessment platform. CEO Colin Kealey said Firefly’s clinicians are “well positioned to evaluate innovative treatment options” for families seeking an alternative to medication. NeuroSigma began U.S. sales of its second-generation Monarch device in July 2026, after developing a reported waitlist of more than 1,500 patients, caregivers and healthcare providers. The partnership therefore arrives at a potentially important commercial moment as NeuroSigma works to expand awareness and access.
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