FDA-cleared AI devices for neurology 2025
2025 has 19 neurology AI devices, 26.7% more than 2024 (15). That is 26% of the 73 neurology devices on the FDA list, and 5.7% of all AI-device decisions dated 2025. The most active were Augmedics, Ltd. (2), Nox Medical Ehf (2), THINK Surgical, Inc. (2). The newest is Ceribell Delirium Monitor System from Ceribell, Inc., decided on December 8, 2025.
Companies in 2025
By month
Product codes
OLOOrthopedic Stereotaxic Instrument4SBFOrthopedic Augmented Reality4OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2POSPhysiological Signal Based Seizure Monitoring System2QPFPediatric Autism Spectrum Disorder Diagnosis Aid2HAWNeurological Stereotaxic Instrument1NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid1OLVStandard Polysomnograph With Electroencephalograph1All 19 devices
- Ceribell Delirium Monitor SystemCeribell, Inc. · Neurology
- Nelli (Version 7.11)Neuro Event Labs OY · Neurology
- DeepRESPNox Medical Ehf · Neurology
- xvision Spine systemAugmedics, Ltd. · Neurology
- SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc. · Neurology
- Mazor X System / Mazor X Stealth EditionMazor Robotics Ltd. · Neurology
- Felix NeuroAI SystemFasikl Incorporated · Neurology
- TMINI Miniature Robotic SystemTHINK Surgical, Inc. · Neurology
- EpiMonitorEmpatica Srl · Neurology
- OTS HipOrtoma AB · Neurology
- Canvas DxCognoa, Inc. · Neurology
- autoSCORE (V 2.0.0)Holberg EEG AS · Neurology
- EarliPoint SystemEarliTec Diagnostics · Neurology
- DeepRESPNox Medical ehf · Neurology
- xvision Spine systemAugmedics Ltd. · Neurology
- Falcon HSTCompumedics Limited · Neurology
- ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · Neurology
- ARVIS® ShoulderKico Knee Innovation Company Pty Ltd · Neurology
- TMINI Miniature Robotic SystemTHINK Surgical, Inc. · Neurology
Frequently asked questions
How many FDA-cleared AI neurology devices were there in 2025?
19 AI-enabled neurology devices have a final decision dated 2025, from 16 companies.
How does 2025 compare with 2024 for AI neurology devices?
2025 has 19 neurology AI devices, 26.7% more than 2024 (15).
Which companies cleared the most AI neurology devices in 2025?
Augmedics, Ltd. (2), Nox Medical Ehf (2), THINK Surgical, Inc. (2).
What was the most recent AI neurology device in 2025?
Ceribell Delirium Monitor System from Ceribell, Inc. (K251936), decided on December 8, 2025. Product code NCG.
Which product codes were most common for AI neurology devices in 2025?
OLO (Orthopedic Stereotaxic Instrument): 4; SBF (Orthopedic Augmented Reality): 4; OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph): 2.
Cite as: AI Device Radar, “FDA-cleared AI devices for neurology 2025,” https://ai-device-radar.vercel.app/specialty/neurology/2025 (FDA list through 2026-06-29).