Diagnostics company Neuro Event Labs Oy (NEL) has 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, recognised 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 prioritise the review of seizure events with positive motor components according to the company.
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.
“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.”
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.”
Jacqueline French, MD, Medical Director of the Epilepsy Foundation and Professor of Neurology at NYU Langone Health’s Comprehensive Epilepsy Center said: “The epilepsy field welcomes technologies that enhance patient care and allow more efficient use of EMU resources.”
Martijn Wallert, CEO, Neuro Event Labs said: “This milestone marks a new chapter for Neuro Event Labs. 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 U.S.”
Commercial rollout will begin in early 2026 with priority focus on major academic hospitals and high-volume epilepsy centers.
