Great news from Neuro Event Labs Oy, as Nelli®, their AI-powered seizure detection and characterization device, has officially received European MDR (Medical Device Regulation) certification as a Class IIa medical device.
Nelli®, the AI-powered seizure detection and characterization device, has officially received European MDR (Medical Device Regulation) certification as a Class IIa medical device!
This milestone makes Nelli the only seizure detection and epilepsy monitoring device to achieve MDR compliance, solidifying its role in delivering advanced epilepsy diagnostics and monitoring solutions for both hospital and home environments.
What MDR Certification Means:
- Stringent clinical evaluation: Demonstrates robust safety and performance backed by rigorous clinical evidence.
- Enhanced post-market surveillance: Ensures ongoing safety, functionality, and alignment with the latest medical standards.
- Compliance with industry-leading standards: Delivers reliability for healthcare professionals and organizations conducting clinical trials.
Kaapo Annala, founder and CEO of Neuro Event Labs Oy , shared:
“This is a major regulatory milestone for Neuro Event Labs on the international epilepsy stage. As we continue to provide objective and accurate biomarkers with advanced AI solutions, Nelli’s MDR certification will reinforce the confidence of healthcare professionals and industry in implementing transformative new technology for epilepsy care.”
With this achievement, Neuro Event Labs remains committed to driving innovation in epilepsy diagnostics and empowering healthcare professionals with the tools they need to deliver the best care for patients.
