Firefly Neuroscience has struck a partnership with bioelectronic device maker NeuroSigma to broaden clinician reach for the latter’s Monarch eTNS System through its Evoke customer base in the US.
The deal is intended to address two recognised gaps in paediatric attention-deficit/hyperactivity disorder (ADHD) care. These are the need for objective data on brain function and the limited availability of non-medication treatment options for eligible patients.
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Firefly is an AI company focused on precision neuroscience.
It will introduce the Monarch therapy to psychiatry, neurology and behavioural health practices that already rely on its US Food and Drug Administration (FDA) 510(k)-cleared Evoke EEG/ERP platform.
The Monarch eTNS System is the first non-drug treatment for paediatric ADHD to receive FDA clearance. A palm-sized, prescription-only device, it works by delivering mild external trigeminal nerve stimulation through a small adhesive patch placed on a child’s forehead during sleep.
The therapy is cleared as a monotherapy for children aged seven to twelve who have ADHD and are not currently taking prescription ADHD medication.
NeuroSigma launched US commercial shipments of a second-generation Monarch device in July 2026, having built a waitlist comprising more than 1,500 patients, caregivers and healthcare providers. In September the company widened family payment options by adding third-party instalment plans.
Firefly CEO Greg Lipschitz said: “This partnership represents an important step toward a more objective and personalised 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 merges quantitative electroencephalography and event-related potential testing with AI-driven analytics. Underpinned by a proprietary collection of more than 200,000 EEG/ERP brain scans, the system provides clinicians with objective measures of individual brain function and enables them to monitor changes over time.
In March 2026, the company revealed EEG/ERP biomarkers, identified through Evoke-collected data, that may help distinguish among the three recognised ADHD presentations. These are predominantly inattentive, predominantly hyperactive-impulsive and combined.
Firefly has said that, subject to further research and validation, the findings could eventually support more targeted treatment matching and objective monitoring of patient response.
Under the terms of the agreement, Firefly is responsible for introducing the Monarch device to its clinician network and supporting education around the therapy. NeuroSigma will supply clinical training, prescribing assistance and product fulfilment via its specialty pharmacy partner.
NeuroSigma president and CEO Colin Kealey said: “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.”
NeuroSigma, headquartered in Los Angeles, is also studying the Monarch eTNS System in further neurodevelopmental and neurological conditions, including autism spectrum disorder, learning disabilities and drug-resistant epilepsy.
The FDA has granted the device Breakthrough Device Designation for drug-resistant epilepsy; however, all additional indications remain investigational and are not FDA-cleared.
The NeuroSigma tie-up is Firefly’s second partnership announcement in recent weeks.
Earlier this month, the company disclosed a separate collaboration with Radial, which operates a network of brain medicine clinics in the US.
Under that partnership, Evoke will be integrated with Radial’s proprietary AI-native operating system, RadialOS. This planned integration is designed to incorporate objective brain-function measures into Radial’s diagnostic workflow.
