Firefly Neuroscience (NASDAQ: AIFF) has announced a strategic partnership to expand clinician awareness of and access to NeuroSigma’s Monarch eTNS System, the first FDA-cleared non-drug for pediatric attention-deficit/hyperactivity disorder (ADHD), through Firefly’s growing nationwide network of Evoke clinician customers.
The collaboration brings together complementary technologies designed to address two significant needs in pediatric ADHD care: access to objective information about brain function and availability of a non-medication treatment option for eligible patients.
Under the agreement, Firefly will introduce the Monarch eTNS System to its Evoke clinician customers and support clinician education regarding the therapy. NeuroSigma will provide clinical training, prescribing support and product fulfillment through its specialty pharmacy partner.
The Monarch eTNS System is the first non-drug treatment for pediatric ADHD cleared by the FDA. Under the partnership, Firefly will introduce the Monarch device to psychiatry, neurology and behavioral health practices that use its FDA 510(k)-cleared, AI-powered Evoke EEG/ERP platform.
In a statement, Greg Lipschitz, CEO of Firefly, commented, “This partnership represents an important step toward a more objective and personalized approach to pediatric ADHD care. Clinicians need better tools to understand how an individual patient’s brain is functioning, more treatment options from which to choose and objective ways to evaluate changes over time. By introducing NeuroSigma’s FDA-cleared, non-drug therapy to our Evoke clinician network, we are connecting measurement-driven practices with an important treatment option for eligible children and their families.”
Firefly’s Evoke platform combines quantitative electroencephalography (qEEG) and event-related potential (ERP) testing with AI-powered analytics. Drawing upon Firefly’s proprietary database of more than 200,000 EEG/ERP brain scans, Evoke provides clinicians with objective information about individual brain function, including in patients whose symptoms may overlap across multiple conditions, and enables clinicians to track changes over time.
In March 2026, Firefly announced the discovery of EEG/ERP biomarkers, identified using data collected through Evoke, that may help differentiate among the three ADHD presentations: predominantly inattentive, predominantly hyperactive-impulsive and combined. Subject to further research and validation, Firefly believes these findings could ultimately help clinicians better match patients with appropriate treatment approaches and objectively monitor their response to intervention.
The prescription-only Monarch eTNS System is a palm-sized device that delivers mild external trigeminal nerve stimulation (eTNS) through a small adhesive patch placed on a child’s forehead while the child sleeps. It is FDA-cleared as a monotherapy for children ages seven through 12 with ADHD who are not currently taking prescription ADHD medication.
NeuroSigma commenced U.S. sales of its second-generation Monarch device in July 2026, following the development of a waitlist comprising more than 1,500 patients, caregivers and healthcare providers. In September, the company expanded payment options for families, including third-party installment plans.
Colin Kealey, MD, president and CEO of NeuroSigma, noted, “Firefly has built a network of clinicians who are already embracing a more objective, measurement-driven approach to brain health. These clinics are well positioned to evaluate innovative treatment options for children and families seeking an alternative to medication. With our second-generation Monarch device now shipping and expanded payment options available, this partnership gives us an efficient pathway to educate more clinicians and broaden access to the first FDA-cleared, non-drug treatment for pediatric ADHD.”
Lauren Hernandez, MD, a board-certified pediatrician with advanced certification in genomic medicine, and chief medical officer of the pediatric program for NuWell Medicine, remarked, “For too long, we have relied on symptom checklists and traditional evaluations alone to understand a child’s brain. Advanced qEEG technology, such as Evoke, allows us to see how a child’s brain is actually functioning in real time, giving us a deeper understanding of attention, learning, emotional regulation, and overall neurological health. This technology helps identify the unique patterns behind challenges often labeled as ADHD, while also revealing when symptoms may be driven by anxiety, sensory processing differences, autonomic nervous system dysregulation, or other underlying factors.”
Dr. Hernandez added, “By understanding how the brain, gut, and autonomic nervous system work together, we can create more personalized and effective roadmaps that support resilience, health, and lifelong success. Evoke™ provides valuable insights that can help validate the need for medication when appropriate, while also helping families avoid unnecessary treatment when the root cause lies elsewhere. We are also excited about emerging tools, such as the Monarch eTNS System, which offer new opportunities to support children with ADHD and autism. For the first time, we have objective tools to measure progress and improvement over time, aligning perfectly with the Reformative Medicine approach of identifying what’s off balance, optimizing function, and restoring balance across the body’s interconnected systems.”
According to a 2024 study published in the Journal of Clinical Child & Adolescent Psychology, approximately one in nine U.S. children has received an ADHD diagnosis, representing an estimated 7.1 million children. And among the approximately 6.5 million children with current ADHD, nearly one-third received no ADHD-specific treatment. At the same time, many families are seeking alternatives to stimulant medication for their children.
