Firefly partners with NeuroSigma to bring Monarch eTNS to Evoke clinics

25 Sep 2026 (ET): Firefly Neuroscience said it will introduce NeuroSigma’s second-generation Monarch eTNS System — an FDA-cleared forehead-patch stimulator used at home during sleep — to psychiatry, neurology, and behavioral health practices that already run Firefly’s AI-powered Evoke EEG/ERP platform.

HEALTH desk — clinics that already run Firefly’s Evoke scans are being offered a second tool: NeuroSigma’s Monarch, a prescription forehead patch the FDA has cleared for children ages 7 through 12 with ADHD who are not on ADHD medication, used at home during sleep. A scan and a device answer different questions. The scan is how those clinics measure brain activity. The device is a non-drug treatment, not a reading of the scan. Putting them in one clinician network matters for families who want an option besides a stimulant, because the practice that measures the child is the practice being taught the device. The release does not say the scan chooses the treatment, and the March biomarker work is still subject to further research.

What the lede says the partnership is. Firefly, called an artificial intelligence company advancing precision neuroscience, and NeuroSigma, called a bioelectronic medical device company, 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. eTNS means external trigeminal nerve stimulation: a mild signal through the skin to a nerve in the face. That gloss is this desk’s. The page prints eTNS and spells the phrase once. Nationwide and growing are the release’s words. This desk did not count the clinics.

The three lines above the dateline, kept as the release’s frame. The first says the partnership will introduce NeuroSigma’s second-generation Monarch eTNS System to Firefly’s nationwide network of Evoke clinicians. The second says the collaboration brings together an FDA-cleared pediatric ADHD treatment and Firefly’s objective brain-function assessment platform and AI-driven ADHD biomarker research. The third says Monarch offers an at-home, non-medication treatment option for eligible children ages 7 through 12. ADHD is attention-deficit/hyperactivity disorder. The FDA is the U.S. Food and Drug Administration. Those glosses are this desk’s. Second-generation, objective, and eligible are the release’s words.

What the release says Monarch is, and the age limit on the clearance. The Monarch eTNS System is described as the first non-drug treatment for pediatric ADHD cleared by the FDA. First is the release’s word. It is not a product census this desk made. The prescription-only device is palm-sized. It delivers mild external trigeminal nerve stimulation through a small adhesive patch on the 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. Monotherapy, here, means the device is cleared to be used on its own, not added on top of an ADHD medicine. That gloss is this desk’s. The safety section says it is indicated for that same age band and is intended for home use during sleep under the supervision of a caregiver. While the child sleeps is the product paragraph. During sleep under a caregiver is the safety paragraph. Do not drop the caregiver. Palm-sized, mild, and first are the release’s. This desk did not fit a patch.

Who does what under the agreement. 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, and will support clinician education. A 510(k) is the FDA clearance path the release names for Evoke. EEG is an electroencephalogram, a recording of electrical activity from the scalp. ERP is an event-related potential, a brain response tied to a task or a stimulus. Those glosses are this desk’s. NeuroSigma will provide clinical training, prescribing support, and product fulfillment through its specialty pharmacy partner. The release does not name that pharmacy. Do not invent the name. Education, training, prescribing support, and fulfillment are the release’s split of the work. This desk did not attend a training.

What Evoke is, and whose scan count that is. Firefly’s Evoke platform combines quantitative electroencephalography, or qEEG, and event-related potential testing with AI-powered analytics. Quantitative, here, means the recording is turned into numbers a clinician can compare, not only a tracing to look at. That gloss is this desk’s. The platform draws on Firefly’s proprietary database of more than 200,000 EEG/ERP brain scans. Proprietary means the company owns the database. More than 200,000 is the release’s count. The about box says over 200,000, and that the company believes the set is the world’s largest known standardized EEG/ERP repository. Believes, and world’s largest, are the company’s. This desk did not audit the archive. The release says Evoke gives clinicians objective information about individual brain function, including when symptoms overlap across conditions, and lets them track changes over time. The about box says the FDA-510(k)-cleared Evoke System is designed to support diagnostic and treatment monitoring for depression, dementia, anxiety disorders, concussions, ADHD, and PTSD. PTSD is post-traumatic stress disorder. That gloss is this desk’s. Designed to support is not a claim that Evoke diagnoses each of those conditions by itself.

The March 2026 biomarker line, which is an earlier announcement inside this release. Firefly said that in March 2026 it announced EEG/ERP biomarkers, identified with data collected through Evoke, that may help differentiate among the three ADHD presentations: predominantly inattentive, predominantly hyperactive-impulsive, and combined. A biomarker, here, is a measured signal the company says tracks with a clinical picture. That gloss is this desk’s. The release says the findings are subject to further research and validation. Firefly believes they could ultimately help clinicians match patients with treatment and monitor response. May, believes, could, and ultimately are the release’s hedges. This filing is the 25 Sep partnership. It is not a new biomarker paper.

When the second-generation device went on sale, and what September changed about paying for it. NeuroSigma commenced U.S. sales of its second-generation Monarch in July 2026, after a waitlist of more than 1,500 patients, caregivers, and healthcare providers. Commenced is the release’s word for the start of sales. More than 1,500 is the release’s waitlist size. This desk did not count the names. In September the company expanded payment options for families, including third-party installment plans. Third-party means a company other than NeuroSigma. The release does not name that company, and it does not print a price. Do not invent either.

The prevalence lines the release cites, kept as the release’s citations. A 2024 study in the Journal of Clinical Child & Adolescent Psychology, Danielson and colleagues, is the footnote. The release says approximately one in nine U.S. children has received an ADHD diagnosis, an estimated 7.1 million children, and that among the approximately 6.5 million children with current ADHD, nearly one-third received no ADHD-specific treatment. Approximately, estimated, and nearly are the release’s. One in nine is about 11 percent. 7.1 million is the release’s estimate of children who have received an ADHD diagnosis. 6.5 million is the release’s count of children with current ADHD. Nearly one-third of that current group is the share the release says got no ADHD-specific treatment. Those translations are this desk’s. This desk did not rerun the survey. The same paragraph says many families are seeking alternatives to stimulant medication, with two further footnotes, Lu and colleagues and Drechsler and colleagues. That sentence is the release’s gloss of those papers. It is not a finding this desk pulled from the PDFs.

Greg Lipschitz, as a quote, not as a measured outcome. Greg Lipschitz, chief executive of Firefly, said the partnership is an important step toward a more objective and personalized approach to pediatric ADHD care. He said clinicians need better tools to understand how an individual patient’s brain is functioning, more treatment options to choose from, and objective ways to evaluate changes over time. He said that introducing NeuroSigma’s FDA-cleared, non-drug therapy to the Evoke clinician network connects measurement-driven practices with a treatment option for eligible children and their families. Important, better, and personalized are his sentences. They are not a trial result this desk calculated. This desk did not interview him.

Colin Kealey, as a quote, not as a count of new prescriptions. Colin Kealey, M.D., president and chief executive of NeuroSigma, said Firefly has built a network of clinicians already using a measurement-driven approach to brain health, and that those clinics are positioned to evaluate treatment options for families seeking an alternative to medication. He said the second-generation Monarch is now shipping, expanded payment options are available, and the partnership is a way to educate more clinicians and broaden access to what he calls the first FDA-cleared, non-drug treatment for pediatric ADHD. Now shipping is his tense for the device. First is his word, matching the release’s. This desk did not audit shipments.

Lauren Hernandez, as a quote, and the limit the about box puts on the conditions she names. Lauren Hernandez, M.D., is described as a board-certified pediatrician with advanced certification in genomic medicine and chief medical officer of the pediatric program for NuWell Medicine. She praises qEEG, names Evoke, and says she is excited about emerging tools such as Monarch for children with ADHD and autism. Autism in that sentence is hers. The NeuroSigma about box says the company is also investigating Monarch for autism spectrum disorder, learning disabilities, and drug-resistant epilepsy. It says the FDA has granted Breakthrough Device Designation for drug-resistant epilepsy. It says these pipeline indications are investigational and not FDA-cleared. Breakthrough designation is not a clearance. That gloss is this desk’s. Do not file her autism sentence as an FDA clearance. This desk did not interview her.

Who the about boxes say the companies are. NeuroSigma is a bioelectronic medical device company based in Los Angeles. Its lead product is Monarch, described again as the first non-drug treatment for pediatric ADHD cleared by the FDA. The learn-more lines are www.neurosigma.com and www.monarch-etns.com. Firefly Neuroscience, Inc. (NASDAQ: AIFF) applies AI and large-scale electrophysiological data so clinicians can see how one patient’s brain is functioning. Electrophysiological means the electrical signals the brain gives off. That gloss is this desk’s. The learn-more line is www.fireflyneuro.com. Investor and media contacts on the page: for Firefly, Stephen Kilmer, (646) 274-3580, stephen.kilmer@fireflyneuro.com. For NeuroSigma, Colin Kealey, M.D., ckealey@neurosigma.com. This desk did not call them.

The safety block, which is the limit on the device in this filing. Monarch is available by prescription only. It should not be used by patients with an implanted cardiac or neurostimulation system, or an implanted metallic or electronic device in the head. Do not apply it to the neck or chest. Do not use it in the bath or shower. Do not use it near electrical monitoring equipment such as cardiac monitors. Apply the patch only to healthy, clean, intact skin. The most commonly reported side effects are drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. The page says to talk with the child’s clinician, and it points to the Instructions for Use for the full safety text. Those lines are the release’s. They are not dosing advice from this desk.

What the forward-looking paragraph prints, including the misspelled name. The release warns that statements about the collaboration’s benefits, Firefly’s ADHD biomarker research, and future plans are forward-looking and may not happen. On the BioSpace page this desk read, that paragraph prints the partner’s name as NeruSigma, twice, and it prints the word business twice in a row. Those letters are that page’s. They are not a second company, and this desk did not see the GlobeNewswire HTML to check whether the wire spells the name the same way. The paragraph points at Firefly’s SEC risk factors. It is the limit on the hopes in the quotes.

What the card shows. The card is NeuroSigma’s Monarch eTNS Gen 2 handheld, a product still on a dark navy field. The white body carries a screen. Orange type reads 3.0. The screen also shows a battery mark, a lock, and the line Press O to Go. Blue type under the screen reads MONARCH. Three blue controls sit below: a plus, a circle, and a minus. Those marks are the device’s. The age band, the 200,000 scans, and 07:45 ET are not printed as captions on this card. The card has no desk date laid over it. The catalog chip is HEALTH.

Plain English for the rest of the card. Firefly runs Evoke, an AI tool that reads brain-wave tests, in psychiatry, neurology, and behavioral health clinics. NeuroSigma makes Monarch, a prescription patch on the forehead that stimulates a facial nerve while a child sleeps. The FDA has cleared that device on its own for ADHD in children ages 7 through 12 who are not already taking an ADHD medicine. The 25 Sep announcement says Firefly will introduce the device to those Evoke clinics and help educate clinicians, and NeuroSigma will train them, help with prescribing, and fill the product through a specialty pharmacy the release does not name. U.S. sales of this second-generation unit started in July 2026 after a waitlist of more than 1,500. In September the company added installment plans. The release’s cited study puts an ADHD diagnosis at about one in nine U.S. children, and says nearly a third of children with current ADHD got no ADHD-specific treatment. The scan does not, on this page, pick the treatment. Autism and the other pipeline uses are investigational, not cleared. The card is the device.

PRIMARY here: Firefly Neuroscience, Inc.’s 25 Sep 2026 GlobeNewswire release 3369065, read as the same text on BioSpace the same day — Tier A PRIMARY, the company’s own wire. STATUS PRIMARY. The desk label on the chip is CONFIRMED because that is the catalog word for a primary page we can stand on. The partnership, the Evoke clinician network, the second-generation Monarch, the FDA-cleared non-drug claim, the psychiatry, neurology, and behavioral health introduction, clinician education, NeuroSigma’s training and prescribing support and specialty-pharmacy fulfillment, the palm-sized patch during sleep, monotherapy for ages 7 through 12 not on ADHD medication, caregiver supervision at home, more than 200,000 scans, the March 2026 biomarker line and its validation hedge, July 2026 U.S. sales, the waitlist of more than 1,500, September installment plans, the Danielson one-in-nine and nearly-one-third lines, the Lipschitz and Kealey quotes, the Hernandez quote, the investigational pipeline, and the safety block are that release’s. NOT claimed: that this desk loaded the GlobeNewswire HTML, that 07:45 ET is printed on the BioSpace page, that 8:56 a.m. Eastern is the wire stamp, a named specialty pharmacy, a price, a prescription this desk wrote, that the scan selects Monarch, that the March biomarkers are validated, an FDA clearance for autism, epilepsy, or learning disabilities, that NeruSigma is a company, a login, a stock tip, or investment advice. The card is the Monarch Gen 2 device. Distinct from the already-filed knowtex-va-ambient-scribe, gene-solutions-nipt-preterm, basalt-health-series-a, and black-talon-aura-ai.