FDA-cleared AI devices for neurology 2024
2024 has 15 neurology AI devices, 36.4% more than 2023 (11). That is 20.5% of the 73 neurology devices on the FDA list, and 6.4% of all AI-device decisions dated 2024. The most active were Beacon Biosignals, Inc. (2), Epitel, Inc (2), 7D Surgical ULC (1). The newest is FLASH EVD System (10-0002) from 7D Surgical ULC, decided on December 27, 2024.
Companies in 2024
By month
Product codes
OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph5OLOOrthopedic Stereotaxic Instrument3OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2HAWNeurological Stereotaxic Instrument1LELDevice, Sleep Assessment1POSPhysiological Signal Based Seizure Monitoring System1QWTPrognostic Assessment Software Of Mild Cognitive Impairment1SBFOrthopedic Augmented Reality1All 15 devices
- FLASH EVD System (10-0002)7D Surgical ULC · Neurology
- NeuroMatchLVIS Corporation · Neurology
- Dreem 3SBeacon Biosignals, Inc. · Neurology
- REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc · Neurology
- xvision Spine SystemAugmedics Ltd. · Neurology
- encevis (2.1)AIT Austrian Institute of Technology GmbH · Neurology
- ARVIS® ShoulderInsight Medical Systems, Inc. · Neurology
- Oxevision Sleep DeviceOxehealth Limited · Neurology
- Automatic RegistrationBrainlab AG · Neurology
- OTS HipOrtoma AB · Neurology
- SleepStageMLBeacon Biosignals, Inc. · Neurology
- EpiMonitorEmpatica Srl · Neurology
- BrainSeeDarmiyan, Inc. · Neurology
- autoSCOREHolberg EEG AS · Neurology
- REMI AI Discrete Detection ModuleEpitel, Inc. · Neurology
Frequently asked questions
How many FDA-cleared AI neurology devices were there in 2024?
15 AI-enabled neurology devices have a final decision dated 2024, from 13 companies.
How does 2024 compare with 2023 for AI neurology devices?
2024 has 15 neurology AI devices, 36.4% more than 2023 (11).
Which companies cleared the most AI neurology devices in 2024?
Beacon Biosignals, Inc. (2), Epitel, Inc (2), 7D Surgical ULC (1).
What was the most recent AI neurology device in 2024?
FLASH EVD System (10-0002) from 7D Surgical ULC (K242480), decided on December 27, 2024. Product code HAW.
Which product codes were most common for AI neurology devices in 2024?
OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph): 5; OLO (Orthopedic Stereotaxic Instrument): 3; OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph): 2.
Cite as: AI Device Radar, “FDA-cleared AI devices for neurology 2024,” https://ai-device-radar.vercel.app/specialty/neurology/2024 (FDA list through 2026-06-29).