Firefly Neuroscience, Inc. develops AI-enabled precision neuroscience tools built around EEG/ERP brain data, including its FDA 510(k)-cleared brain analytics technology, the BNA platform, the Evoke System and the CLEAR Platform. News about AIFF centers on commercialization of cognitive electrophysiology analytics, growth in brain scan volumes, expansion of its standardized EEG/ERP data repository, and the use of NVIDIA GPU acceleration for signal processing and biomarker discovery.
Recurring company updates also cover research applications in neurological and mental health conditions such as ADHD, depression, dementia, anxiety disorders, concussions and cognitive disorders; partnerships with clinics, researchers and institutional customers; integration of Evoke Neuroscience; and periodic financial results tied to equipment sales, rentals, per-use fees and services for projects or clinical studies.
Firefly Neuroscience (NASDAQ: AIFF) outlined how its commercially available Versus platform supports its non-invasive brain-computer interface strategy in human performance. More than 3,000 Versus headsets have shipped, and the platform generates commercial revenue. Versus pairs a wireless brainwave-measuring headset with interactive training software.
Firefly is also building an AI foundation model using more than 200,000 standardized EEG/ERP brain scans, its FDA 510(k)-cleared Evoke platform and NVIDIA GPU acceleration. The company believes this work could support more personalized training, improved brain-signal interpretation and new applications, subject to further development and validation.
ACCESS Newswire (ACCS) is among eight public companies presenting at The Small Cap Showcase investor conference in New York City. The lineup also includes First Phosphate, Cerrado Gold, Coiled Therapeutics, Decoy Therapeutics, Firefly Neuroscience, Eco Wave Power and Sparta Commercial Services. The event includes company presentations and one-on-one investor meetings; ACCESS Newswire is scheduled to present at 3:00 PM Eastern Time, with times subject to change.
Firefly Neuroscience (AIFF) and NeuroSigma announced a partnership on September 25, 2026, to introduce Monarch to Evoke clinicians.
Firefly will present NeuroSigma's second-generation Monarch eTNS System to practices using its FDA 510(k)-cleared Evoke brain-function assessment platform. Firefly will support clinician education, while NeuroSigma will provide clinical training, prescribing support and fulfillment through a specialty pharmacy partner. Monarch is FDA-cleared for pediatric ADHD as a prescription-only, non-drug treatment for children ages 7 through 12 who are not taking prescription ADHD medication. It is used at home during sleep under caregiver supervision.
NeuroSigma began U.S. sales of the second-generation Monarch in July 2026, after building a waitlist of more than 1,500 patients, caregivers and healthcare providers. Firefly identified potential ADHD-related EEG/ERP biomarkers in March 2026; those findings require further research and validation.
Firefly Neuroscience (AIFF) announced a strategic collaboration with Radial on September 17, 2026 to pursue integration of Firefly’s FDA 510(k)-cleared, AI-powered Evoke™ EEG/ERP platform into RadialOS, Radial’s AI-native operating system for brain medicine.
The planned integration is intended to bring objective measures of brain function into Radial’s diagnostic workflow, helping clinicians better understand patients, select potential treatment pathways, coordinate care and track outcomes over time. Radial operates the country’s largest brain medicine clinical network, with 27 clinics across seven states, and delivers treatments such as transcranial magnetic stimulation, medications and other interventional approaches.
Firefly Neuroscience (NASDAQ: AIFF) reported a 291% year-over-year increase in TMS center customer clinical assessments using its FDA 510(k)-cleared, AI-powered EEG/ERP platform, Evoke. The system combines quantitative EEG (qEEG) and event-related potentials (ERP) to provide a more complete view of brain activity in clinical settings.
In TMS centers, Evoke brain scans display electrophysiological signals that physicians may use to assess patterns commonly associated with depression and mood disorders, anxiety disorders, and ADHD/attention-related conditions. According to the company, this supports more individualized TMS treatment decisions, treatment monitoring over time, and objective evidence of treatment response. Firefly also highlights a proprietary database of over 200,000 standardized EEG/ERP brain scans that underpins its precision neuroscience approach.
Firefly Neuroscience (NASDAQ: AIFF) and Next Health announced a strategic partnership to launch a precision cognitive health platform that integrates Firefly’s FDA 510(k)-cleared, AI-powered EEG/ERP brain biomarker technology with personalized cognitive peptide protocols delivered through Next Health’s longevity clinics.
The initiative follows an FDA Advisory Committee vote recommending that six peptides, including Epitalon and Semax, become eligible for pharmacy compounding, a non-binding step that may broaden physician access if the FDA acts. Neither peptide is FDA-approved and the recommendation does not address safety or efficacy. The collaboration aims to provide objective brain function metrics to help clinicians personalize, monitor, and optimize emerging peptide-based cognitive therapies and to develop standardized protocols supporting data-driven cognitive and longevity care.
Firefly Neuroscience (NASDAQ: AIFF) reported discovery of a novel electrophysiological biomarker for PTSD using its FDA-510(k)-cleared Evoke System. The finding stems partly from its public-private partnership with the U.S. Department of War to support assessment and treatment of active-duty service members and veterans.
The biomarker, identified via deep-learning analysis of EEG and ERP data on NVIDIA L40S GPU infrastructure, may support PTSD diagnostics and treatment decisions. Firefly sees potential applications across defense health, pharmaceutical clinical trials, and clinical psychiatry, aligning with its goal to build an EEG/ERP-based brain foundation model.
Firefly (NASDAQ: AIFF) announced it has surpassed 200,000 standardized EEG/ERP brain scans, driven by organic growth and the May 2025 acquisition of Evoke Neuroscience. Sequential scan volumes grew 5%, 11%, 15%, and 17% in the last four quarters, and the company cites NVIDIA L40S GPU acceleration to boost AI biomarker discovery.
This milestone supports Firefly’s stated goal of building and launching the world’s first EEG/ERP-based foundation model of the human brain.
Firefly (NASDAQ: AIFF) announced a public-private partnership with the Department of War on March 26, 2026, to deploy its FDA 510(k)-cleared, AI-powered EEG/ERP platform for assessment and treatment of PTSD and TBI in U.S. service members and veterans.
The deal expands Firefly’s commercial footprint into U.S. government and defense health sectors, builds on the May 2025 Evoke acquisition, and cites large military health burdens to justify deployment.
Firefly Neuroscience (NASDAQ: AIFF) announced a research advance on March 13, 2026: its AI-powered EEG/ERP platform using data from its FDA 510(k)-cleared Evoke System may help distinguish the three main ADHD subtypes.
The company cites a growing foundation model trained on over 191,000 brain scans, potential clinical uses for subtype-specific treatment guidance and monitoring, and access to NVIDIA GPU acceleration to speed EEG/ERP processing.