Neurology
REMI-AI Rapid Detection Module (REMI-AI RDM)
Epitel, Inc
FDA-cleared AI medical device
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
FDA Submission Metadata
- Submission number
- K240408
- Decision date
- October 2024
- FDA panel
- Neurology
- Product code
- OMB
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.