Firefly Neuroscience and NeuroSigma are joining forces to expand clinician awareness and patient access to a non-drug treatment option for children with attention-deficit/hyperactivity disorder (ADHD). The strategic partnership will connect NeuroSigma’s Monarch eTNS® System with Firefly’s nationwide network of clinicians using its Evoke™ EEG/ERP platform.
The agreement gives Firefly an opportunity to introduce the Monarch system to psychiatry, neurology and behavioral health practices already using its FDA 510(k)-cleared Evoke platform. NeuroSigma will support the rollout with clinical training, prescribing assistance and product fulfillment through its specialty pharmacy partner.
The partnership comes as families and clinicians continue to seek additional options for pediatric ADHD care. A 2024 study published in the Journal of Clinical Child & Adolescent Psychology estimated that about 7.1 million U.S. children had received an ADHD diagnosis, while nearly one-third of children with current ADHD had not received ADHD-specific treatment. The companies see an opportunity to combine objective brain-function assessments with access to a non-medication therapy for eligible patients.
Firefly Brings Brain Measurement Platform to ADHD Care
Firefly’s Evoke platform combines quantitative electroencephalography (qEEG) and event-related potential (ERP) testing with artificial intelligence-based analysis. Its database contains more than 200,000 EEG/ERP brain scans, giving clinicians access to information intended to help assess individual patterns of brain function and monitor changes over time.
For Firefly, the partnership adds a treatment component to a clinician network that has primarily been built around brain measurement and assessment. The company will introduce Monarch to its existing Evoke customers and provide education about the therapy, while NeuroSigma will handle the clinical and prescription support needed after clinicians identify appropriate candidates.
The companies’ technologies address different stages of patient care. Evoke is designed to provide clinicians with quantitative information about brain activity, while Monarch is a prescription treatment intended for a specific pediatric ADHD population.
Firefly has also been investigating whether EEG and ERP data can help distinguish among ADHD presentations. In March 2026, the company announced the discovery of potential biomarkers that may differentiate predominantly inattentive, predominantly hyperactive-impulsive and combined presentations. Firefly said the findings require additional research and validation before they could have broader clinical applications.
The company believes such research could eventually help physicians better understand individual patients and assess changes following treatment. For now, the partnership is focused on connecting its measurement-focused clinical network with an existing FDA-cleared treatment option.
Greg Lipschitz, CEO of Firefly, said the agreement is intended to give clinicians more tools to understand individual brain function, consider additional treatment options and monitor changes over time.
The commercial opportunity is tied to the size and complexity of the pediatric ADHD population in the United States. Families can face different treatment considerations, and some are interested in alternatives to stimulant medication. The availability of a non-drug option provides another pathway for eligible children, although treatment decisions remain dependent on individual clinical circumstances and prescribing requirements.
NeuroSigma Expands Reach for Monarch eTNS System
The Monarch eTNS System is a prescription-only device that delivers mild external trigeminal nerve stimulation through an adhesive patch positioned on a child’s forehead during sleep. The FDA has cleared the system as a monotherapy for children ages 7 through 12 with ADHD who are not currently taking prescription ADHD medication.
NeuroSigma began U.S. sales of its second-generation Monarch device in July 2026. Before the commercial launch, the company had developed a waitlist of more than 1,500 patients, caregivers and healthcare providers. In September, it also expanded payment options for families through third-party installment plans.
Those developments give the partnership a commercial dimension beyond clinician education. NeuroSigma is now working to increase awareness among healthcare providers while also addressing practical factors that can affect access to a prescription medical device.
Colin Kealey, M.D., president and CEO of NeuroSigma, said Firefly’s clinician network represents a group of practices already interested in measurement-based approaches to brain health. He said the partnership could help educate more clinicians about Monarch and broaden access to the device.
The agreement also provides NeuroSigma with a route into additional clinical practices without requiring the company to independently build relationships with every participating provider. Firefly, meanwhile, can expand the range of solutions presented to clinicians using its platform.
Lauren Hernandez, M.D., chief medical officer of the pediatric program at NuWell Medicine, said technologies such as qEEG can provide additional information about brain function and may help clinicians assess changes over time. She also pointed to emerging non-drug approaches such as Monarch as potential options for families.
For Firefly, the partnership fits into its wider effort to position Evoke within clinical settings where objective neurological information can support patient assessment. For NeuroSigma, the agreement provides another channel for increasing awareness of Monarch following its second-generation device launch.
The companies have not announced a specific patient or revenue target for the partnership. Its near-term focus is on introducing Monarch to Firefly’s clinician customers, supporting education and helping qualified practices navigate prescribing and fulfillment.
As both companies expand their respective healthcare networks, the collaboration creates a connection between neurological assessment technology and a non-drug pediatric ADHD therapy. Its progress will ultimately depend on clinician adoption, patient eligibility, regulatory requirements and the ability of families to access the treatment.
For the pediatric ADHD market, the agreement adds another example of how medical device companies and technology providers are building partnerships around diagnosis, monitoring and treatment rather than focusing on a single point in the care pathway.
