Firefly Neuroscience, Inc.
– Partnership will introduce NeuroSigma's second-generation Monarch eTNS® System to Firefly's nationwide network of Evoke™ clinicians –
– Collaboration brings together an FDA-cleared pediatric ADHD treatment and Firefly's objective brain-function assessment platform and AI-driven ADHD biomarker research –
– Monarch offers an at-home, non-medication treatment option for eligible children ages 7 through 12 ––
KENMORE, N.Y. and LOS ANGELES, Sept. 25, 2026 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. ("Firefly") (NASDAQ: AIFF), an artificial intelligence ("AI") company advancing precision neuroscience, and NeuroSigma, Inc. ("NeuroSigma"), a bioelectronic medical device company, today announced a strategic partnership to expand clinician awareness of and access to NeuroSigma's Monarch eTNS® System through 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."