Neuro Event Labs Receives FDA 510(k) Clearance for the Nelli® Seizure Monitoring System

Tampere, Finland - 26th 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. Nelli, recognized by the FDA as a Breakthrough Device, is the world's first non-contact, 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.

Addressing Critical Monitoring Needs in US Hospitals
Growing demand for epilepsy monitoring has strained resources in US hospitals, creating limits on both the capacity and the duration of inpatient observation.

"Nelli's AI-based motor seizure detection helps hospitals expand monitoring capability without adding staff burden," said Kaapo Annala, Founder and COO at Neuro Event Labs. "Combined with its non-contact design and integration to epilepsy monitoring workflows, Nelli enables hospitals to expand their safety and diagnostic monitoring capacity and rapidly deploy in high-demand clinical settings."

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 video-EEG 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 US

Together, the clinical evidence and FDA clearance establish the foundation for Nelli's US commercial launch.

"This milestone marks a new chapter for Neuro Event Labs," said Martijn Wallert, CEO. "Nelli gives hospitals a scalable monitoring solution that immediately supports staff and strengthens diagnostic workflows. We look forward to bringing Nelli to leading epilepsy centers across the US."

Commercial rollout will begin in early 2026 with priority focus on major academic hospitals and high-volume epilepsy centers.

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, non-contact 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.

Neuro Event Labs Oy
Biokatu 10, 3rd floor
33520 Tampere
Finland

Katri Särkikoski
katri.sarkikoski@neuroeventlabs.com

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.

This release was published on openPR.