Neurology
EpiMonitor
Empatica Srl
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
- K232915
- Decision date
- February 2024
- FDA panel
- Neurology
- Product code
- POS
- Clinical task (npj)
- triage
- Data modality (npj)
- Signals
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.
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