Neurology
Nelli (Version 7.11)
Neuro Event Labs OY
FDA-cleared AI medical device
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.
FDA Submission Metadata
- Submission number
- K251506
- Decision date
- November 2025
- FDA panel
- Neurology
- Product code
- POS
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.