Catalyze Capital portfolio company Neuro Event Labs Receives FDA Approval

1 December 2025, Amsterdam — Catalyze Capital is proud to share the exciting news that its portfolio company, Neuro Event Labs (NEL), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its breakthrough device, the Nelli® Seizure Monitoring System. This clearance marks a pivotal moment in NEL’s journey to revolutionise epilepsy diagnostics and opens the door for commercialisation in the U.S. healthcare market.

Nelli® Seizure Monitoring System is a world first for epilepsy diagnostics

As the world’s first non-contact, AI-driven system for detecting and reviewing seizure events, Nelli brings an innovative, scalable solution to hospitals and clinical research environments struggling with capacity limitations. With this FDA approval, NEL now stands at the forefront of clinical innovation in neurology.

“Obtaining FDA approval is a major milestone for Neuro Event Labs and for the Nelli® system,” said Theodoor Rutgers, Partner at Catalyze Capital and Board member at NEL. “We strongly believe in the impact of this technology and the team behind it. We are excited to continue supporting the company as it moves into the next stage of commercial rollout and growth.”

NEL’s success reflects the kind of transformative innovation Catalyze Capital seeks to enable. Catalyze Capital’s investment in Neuro Event Labs aligns with our mission to support high-impact companies in Life Sciences & Health, helping them reach critical inflection points that accelerate market entry and real-world impact.

“A new chapter” for Neuro Event Labs

The FDA’s Breakthrough Device designation previously awarded to Nelli underlines the system’s unique value. Nelli addresses a clear need in U.S. hospitals for scalable, contact-free epilepsy monitoring to enable faster diagnoses, more efficient clinical workflows, and enhanced data quality for both clinicians and clinical trial sponsors.

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

NEL prepares for its U.S. commercial launch in early 2026,  focusing on maximising its global potential. This approval represents more than regulatory success—it signifies real progress for patients, clinicians, and healthcare systems.

About Catalyze Capital

Catalyze Capital is a venture capital firm investing in early-stage companies that apply science an technology to develop innovations that will positively impact people’s lives and the planet’s health. Being part of the Catalyze Group, this fund closely collaborates with Catalyze Innovation Consultants in its scouting & selection, due diligence and portfolio management. We tap into 20+ years experience in advancing innovations and a vast network of industrial and academic partners. Operating from Amsterdam, the Netherlands, Catalyze Capital focuses on European companies active in high-tech sectors, including the Life Science, Sustainable and Deep Tech sectors.

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