Collaboration to use Firefly’s growing nationwide network of Evoke™ clinician customers. The Monarch eTNS® System is the first non-drug treatment for pediatric attention-deficit/hyperactivity disorder ("ADHD") cleared by the U.S. Food and Drug Administration ("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.

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.

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.¹ At the same time, many families are seeking alternatives to stimulant medication for their children.², ³

"This partnership represents an important step toward a more objective and personalized approach to pediatric ADHD care," said Greg Lipschitz, Chief Executive Officer of Firefly. "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 7 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.