Tampere, Finland — 24th November 2025
Neuro Event Labs Oy (NEL), a global healthcare diagnostics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for clinical use of its Nelli® Seizure Monitoring System in the hospital setting. Recognized by the FDA as a Breakthrough Device, Nelli is the world’s first contact-free, AI-driven video and audio monitoring system designed to identify and prioritize the review of seizure events with positive motor components.
With FDA clearance, Nelli becomes a new clinical tool for improving epilepsy diagnostics and expanding monitoring capacity in U.S. hospitals. The platform also provides an objective, advanced measurement tool for documenting seizure outcomes in clinical trials of anti-seizure medications.
Meeting Critical Monitoring Needs in Hospitals
Growing demand for epilepsy monitoring has strained resources in U.S. hospitals, creating limits on both the capacity and the duration of inpatient observation.
“Nelli’s sophisticated AI algorithms help automate data analysis for seizure characterization,” said Kaapo Annala, Founder and Chief Operating Officer at Neuro Event Labs. “Combined with its contact-free design that can be deployed efficiently and scaled quickly, Nelli enables hospitals to expand their safety and diagnostic monitoring capacity by screening and stratifying patients without additional staffing pressure.”
Clinical Validation Demonstrates Strong Performance
The FDA clearance follows a pivotal validation study conducted with Thomas Jefferson University Hospital.
“We’ve found Nelli to be highly sensitive and specific for detecting and classifying motor movements when compared to gold-standard vEEG monitoring,” said Principal Investigator Michael Sperling, MD, Baldwin Keyes Professor of Neurology and Director of the Jefferson Comprehensive Epilepsy Center. “This technology complements our existing diagnostic modalities and significantly expands our monitoring capability.”
The epilepsy community has also expressed support for new diagnostic innovations.
“The epilepsy field welcomes technologies that enhance patient care and allow more efficient use of EMU resources,” said Jacqueline French, MD, Medical Director of the Epilepsy Foundation and Professor of Neurology at NYU Langone Health’s Comprehensive Epilepsy Center.
A Key Milestone for Commercialization in the U.S.
Together, the clinical evidence and FDA clearance establish the foundation for Nelli’s U.S. commercial launch.
“This is a landmark moment for Neuro Event Labs,” said Martijn Wallert, Chief Executive Officer of Neuro Event Labs. “Epilepsy impacts millions of people in the United States, and hospitals are under increasing pressure to monitor more patients with limited resources. Nelli offers a new way forward: accurate, contact-free seizure monitoring that can be deployed efficiently and scaled quickly. We are excited to bring this innovation to clinicians, patients, and partners across the country.”
Commercial rollout of Nelli will begin in the United States early 2026, with priority engagement at leading epilepsy centers and major academic hospitals.
About Nelli®
As a seizure monitoring system, Nelli combines artificial intelligence to automatically detect events with positive motor components, enabling medical specialists to classify seizures more efficiently. The system includes:
• A compact, contact-free video recording unit
• AI-driven software for event detection
• A secure online dashboard for clinicians to review detections and classify seizure events
Nelli provides objective, consistent seizure measurements across sites, using AI to automatically detect and summarize motor events. This increases sensitivity to clinically meaningful endpoints compared to patient-reported diaries and reduces variability between centers. All events are time-stamped, auditable, and available for centralized medical review, strengthening data integrity. Nelli enables fast deployment across global or decentralized trials, helping sponsors scale studies without relying solely on vEEG resources. Together, these features make Nelli a powerful digital endpoint solution for anti-seizure medication trials.
About Neuro Event Labs Oy
Neuro Event Labs Oy (NEL) is an award-winning, privately held, healthcare diagnostic company based in Tampere, Finland with its US office in San Antonio, Texas. NEL is a privately owned, digital health technology company, founded in 2016, with a mission to help epilepsy patients and their physicians with our technology. NEL develops, designs and brings to market software-driven solutions and services in the field of motion analysis and diagnostics, using non-invasive technologies.
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Media Contact:
Katri Sarkikoski for Neuro Event Labs
katri.sarkikoski@neuroeventlabs.com
Nelli, Neuro Event Labs and their stylized logos are registered trademarks of Neuro Event Labs Oy and its subsidiaries.