AI devices with FDA product code OMB — Automatic Event Detection Software For Full-Montage Electroencephalograph
Product code OMB (“Automatic Event Detection Software For Full-Montage Electroencephalograph” in openFDA) covers 8 devices on the FDA AI-enabled list, from 7 companies. Most are reviewed by the Neurology panel (8). The most recent decision was autoSCORE (V 2.0.0) on April 9, 2025.
8AI devices
6Companies
2018First decision
2025-04-09Latest decision
Trend: devices per year
2018202320242025
Top companies
All 8 devices, newest first
- autoSCORE (V 2.0.0)Holberg EEG AS · Neurology
- NeuroMatchLVIS Corporation · Neurology
- REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc · Neurology
- encevis (2.1)AIT Austrian Institute of Technology GmbH · Neurology
- autoSCOREHolberg EEG AS · Neurology
- REMI AI Discrete Detection ModuleEpitel, Inc. · Neurology
- Ceribell Status Epilepticus MonitorCeribell, Inc. · Neurology
- Persyst 14 EEG Review and Analysis SoftwarePersyst Development Corporation · Neurology