AI Device Tracker / Neurology
FDA-authorised AI devices in neurology
73 AI-enabled devices with neurology as the lead FDA review panel, newest first. First in this list: 2014; most recent: 2026-06-27.
| Decision date | Device | Company | FDA record |
|---|---|---|---|
| 2026-06-27 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | K253390 · 510(k) |
| 2026-06-03 | MeRT System | Wave Neuroscience | K260402 · 510(k) |
| 2026-04-22 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | K253256 · 510(k) |
| 2026-03-26 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | K253379 · 510(k) |
| 2026-03-08 | Onera SleepMap (SLEEPMAP) | Onera B.V. | K253668 · 510(k) |
| 2026-03-05 | EarliPoint Assessment | Earlitec Diagnostics | K253442 · 510(k) |
| 2026-02-12 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | K253381 · 510(k) |
| 2026-01-11 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | K252842 · 510(k) |
| 2025-12-08 | Ceribell Delirium Monitor System | Ceribell, Inc. | K251936 · 510(k) |
| 2025-11-21 | Nelli (Version 7.11) | Neuro Event Labs OY | K251506 · 510(k) |
| 2025-11-17 | DeepRESP | Nox Medical Ehf | K252330 · 510(k) |
| 2025-10-03 | xvision Spine system | Augmedics, Ltd. | K251639 · 510(k) |
| 2025-09-29 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | K252054 · 510(k) |
| 2025-09-11 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics Ltd. | K251316 · 510(k) |
| 2025-07-01 | Felix NeuroAI System | Fasikl Incorporated | K250096 · 510(k) |
| 2025-06-20 | TMINI Miniature Robotic System | THINK Surgical, Inc. | K250877 · 510(k) |
| 2025-06-19 | EpiMonitor | Empatica Srl | K250515 · 510(k) |
| 2025-05-16 | OTS Hip | Ortoma AB | K250086 · 510(k) |
| 2025-04-11 | Canvas Dx | Cognoa, Inc. | K243558 · 510(k) |
| 2025-04-09 | autoSCORE (V 2.0.0) | Holberg EEG AS | K243743 · 510(k) |
| 2025-03-26 | EarliPoint System | EarliTec Diagnostics | K243891 · 510(k) |
| 2025-03-14 | DeepRESP | Nox Medical ehf | K241960 · 510(k) |
| 2025-03-13 | xvision Spine system | Augmedics Ltd. | K250255 · 510(k) |
| 2025-02-20 | Falcon HST | Compumedics Limited | K242447 · 510(k) |
| 2025-01-24 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | K243657 · 510(k) |
| 2025-01-13 | ARVIS® Shoulder | Kico Knee Innovation Company Pty Ltd | K243950 · 510(k) |
| 2025-01-06 | TMINI Miniature Robotic System | THINK Surgical, Inc. | K243481 · 510(k) |
| 2024-12-27 | FLASH EVD System (10-0002) | 7D Surgical ULC | K242480 · 510(k) |
| 2024-11-26 | NeuroMatch | LVIS Corporation | K241390 · 510(k) |
| 2024-11-22 | Dreem 3S | Beacon Biosignals, Inc. | K242094 · 510(k) |
| 2024-10-17 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc | K240408 · 510(k) |
| 2024-10-16 | xvision Spine System | Augmedics Ltd. | K241481 · 510(k) |
| 2024-09-27 | encevis (2.1) | AIT Austrian Institute of Technology GmbH | K240993 · 510(k) |
| 2024-04-29 | ARVIS® Shoulder | Insight Medical Systems, Inc. | K240062 · 510(k) |
| 2024-04-03 | Oxevision Sleep Device | Oxehealth Limited | K233618 · 510(k) |
| 2024-03-20 | Automatic Registration | Brainlab AG | K234047 · 510(k) |
| 2024-03-11 | OTS Hip | Ortoma AB | K232140 · 510(k) |
| 2024-03-08 | SleepStageML | Beacon Biosignals, Inc. | K233438 · 510(k) |
| 2024-02-15 | EpiMonitor | Empatica Srl | K232915 · 510(k) |
| 2024-01-11 | BrainSee | Darmiyan, Inc. | DEN220066 · De Novo |
| 2024-01-07 | autoSCORE | Holberg EEG AS | K231068 · 510(k) |
| 2024-01-03 | REMI AI Discrete Detection Module | Epitel, Inc. | K231779 · 510(k) |
| 2023-11-27 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro Inc. | K233243 · 510(k) |
| 2023-09-09 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab AG | K223864 · 510(k) |
| 2023-08-18 | Dreem 3S | Beacon Biosignals, Inc. | K223539 · 510(k) |
| 2023-08-02 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG | K223553 · 510(k) |
| 2023-07-21 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | K223288 · 510(k) |
| 2023-06-29 | EarliPoint | EarliTec Diagnostics, Inc | K230337 · 510(k) |
| 2023-05-23 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | K223504 · 510(k) |
| 2023-04-27 | ENT EM | Brainlab AG | K223734 · 510(k) |
| 2023-04-19 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | K223552 · 510(k) |
| 2023-03-17 | NeuroRPM | New Touch Digital Inc. | K221772 · 510(k) |
| 2023-01-11 | Alpha Control Liner System (ACLS) | Coapt | K223738 · 510(k) |
| 2022-09-21 | SomnoMetry | Neumetry Medical Inc | K221179 · 510(k) |
| 2022-06-08 | EarliPoint System | EarliTec Diagnostics, Inc. | K213882 · 510(k) |
| 2021-10-02 | EYE-SYNC | SyncThink, Inc. | K202927 · 510(k) |
| 2021-06-16 | EnsoSleep | EnsoData, Inc. | K210034 · 510(k) |
| 2021-06-02 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | DEN200069 · De Novo |
| 2020-09-06 | EyeBOX | Oculogica, Inc. | K201841 · 510(k) |
| 2019-11-27 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical Inc. | K192945 · 510(k) |
| 2019-09-11 | BrainScope TBI | BrainScope Company, Inc. | K190815 · 510(k) |
| 2019-09-04 | Myo Plus | Otto Bock Healthcare Products GmbH | K191179 · 510(k) |
| 2019-07-31 | EyeBOX | Oculogica, Inc. | K191183 · 510(k) |
| 2019-05-24 | COMPLETE CONTROL System Gen2 | Coapt, LLC | K191083 · 510(k) |
| 2018-12-28 | EyeBOX | Oculogica, Inc. | DEN170091 · De Novo |
| 2018-12-20 | Embrace | Empatica Srl | K181861 · 510(k) |
| 2018-11-29 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | K182181 · 510(k) |
| 2018-10-05 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | K182112 · 510(k) |
| 2018-09-28 | RightEye Vision System | RightEye, LLC | K181771 · 510(k) |
| 2018-06-29 | NuVasive Pulse System | NuVasive, Incorporated | K180038 · 510(k) |
| 2016-09-22 | Ahead 300 | BRAINSCOPE COMPANY INC | K161068 · 510(k) |
| 2015-05-15 | Brainscope Ahead 200 | BRAINSCOPE COMPANY, INC. | K143643 · 510(k) |
| 2014-11-17 | BrainScope Ahead 100 | BRAINSCOPE COMPANY, INC | DEN140025 · De Novo |
How to read this list
- 510(k) clearance means the FDA found the device substantially equivalent to one already on the market. Most AI devices reach the market this way.
- De Novo is used for new, low-to-moderate risk device types with no existing equivalent; it creates a new device category.
- PMA approval is the strictest route, for higher-risk devices.
- Authorisation means the device may be sold in the US for its stated use. It does not prove that the device improves patient outcomes, and it does not mean your hospital uses it.
- This list covers US FDA decisions only. Approval in the EU (CE marking) or the UK (UKCA) is a separate process.
Source: FDA Artificial Intelligence-Enabled Medical Devices list, downloaded 2026-11-05. Information only, not a recommendation of any device.