Our portfolio company Neuro Event Labs Oy (NEL) has received FDA 510(k) clearance for clinical use of its Nelli® Seizure Monitoring System in US hospitals. As an FDA-recognized Breakthrough Device, Nelli® is the first non-contact, AI-driven video and audio system designed to identify and prioritize review of seizure events with positive motor components.

The clearance addresses a key gap in US epilepsy monitoring capacity, where demand continues to exceed available staff and resources. Nelli® expands observation capabilities without requiring additional personnel and fits easily into existing epilepsy monitoring workflows.
Validation conducted with Thomas Jefferson University Hospital demonstrated high sensitivity and specificity compared with gold-standard video-EEG monitoring. Clinical leaders across the epilepsy community have highlighted the value of technologies that enhance diagnostic accuracy and support more efficient use of EMU resources.

NEL will begin US commercial rollout in early 2026, focusing on major academic hospitals and high-volume epilepsy centers. The company expects Nelli® to strengthen diagnostic workflows and improve access to advanced monitoring in settings where resources are limited.

About Neuro Event Labs
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.

Read the full press release here: https://neuroeventlabs.com/news/fda-clearance