AI devices with FDA product code OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Product code OLZ (“Automatic Event Detection Software For Polysomnograph With Electroencephalograph” in openFDA) covers 9 devices on the FDA AI-enabled list, from 7 companies. Most are reviewed by the Neurology panel (9). The most recent decision was SOMNUM (SOMNUM) on June 27, 2026.
9AI devices
6Companies
2021First decision
2026-06-27Latest decision
Trend: devices per year
202120222023202420252026
Top companies
All 9 devices, newest first
- SOMNUM (SOMNUM)Honeynaps Co., Ltd. · Neurology
- Onera SleepMap (SLEEPMAP)Onera B.V. · Neurology
- DeepRESPNox Medical Ehf · Neurology
- DeepRESPNox Medical ehf · Neurology
- Dreem 3SBeacon Biosignals, Inc. · Neurology
- SleepStageMLBeacon Biosignals, Inc. · Neurology
- Dreem 3SBeacon Biosignals, Inc. · Neurology
- SomnoMetryNeumetry Medical Inc · Neurology
- EnsoSleepEnsoData, Inc. · Neurology