Key findings
- FDA's list contains 73 AI-enabled devices with Neurology as the lead review panel, out of 1614 devices on the full list (4.5%).
- 69 of the 73 neurology devices (95%) were cleared through 510(k); 4 were De Novo grants and 0 were PMA approvals.
- 53 of the 73 (73%) have a final decision date in 2023 or later.
- The most common primary product code is OLO, with 10 devices.
Source: FDA, Artificial Intelligence-Enabled Medical Devices (list content current as of September 4, 2026; CSV downloaded October 27, 2026). Counts are from FDA's data only; PAHL adds no clinical or performance judgments.
How many AI neurology devices has FDA authorized each year?
| Year of final decision | Devices |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 11 |
| 2024 | 15 |
| 2025 | 19 |
| 2026 | 8 |
Which regulatory pathways do they use?
| Pathway (from submission number prefix) | Devices | Share |
|---|---|---|
| 510(k) | 69 | 95% |
| De Novo | 4 | 5% |
For what each pathway means, see our SaMD planning page and Is my app a medical device?
Which product codes are most common?
| Primary product code | Devices |
|---|---|
| OLO | 10 |
| OLZ | 9 |
| HAW | 8 |
| OMB | 8 |
| QPF | 6 |
| GXY | 5 |
| SBF | 5 |
| POS | 4 |
| QEA | 4 |
| PIW | 4 |
| SIG | 1 |
| GWF | 1 |
| NCG | 1 |
| QBC | 1 |
| OLV | 1 |
| LEL | 1 |
| QWT | 1 |
| PGW | 1 |
| GYD | 1 |
| GWN | 1 |
Product codes are FDA's device classification codes; follow a link for FDA's definition of each.
All 73 AI-enabled neurology devices on FDA's list
| Decision date | Device | Company | Submission | Product code |
|---|---|---|---|---|
| 2026-06-27 | SOMNUM (SOMNUM) | Honeynaps Co., Ltd. | K253390 | OLZ |
| 2026-06-03 | MeRT System | Wave Neuroscience | K260402 | SIG |
| 2026-04-22 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | K253256 | GXY |
| 2026-03-26 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | K253379 | HAW |
| 2026-03-08 | Onera SleepMap (SLEEPMAP) | Onera B.V. | K253668 | OLZ |
| 2026-03-05 | EarliPoint Assessment | Earlitec Diagnostics | K253442 | QPF |
| 2026-02-12 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application | Medtronic Navigation, Inc. | K253381 | OLO |
| 2026-01-11 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | K252842 | GWF |
| 2025-12-08 | Ceribell Delirium Monitor System | Ceribell, Inc. | K251936 | NCG |
| 2025-11-21 | Nelli (Version 7.11) | Neuro Event Labs OY | K251506 | POS |
| 2025-11-17 | DeepRESP | Nox Medical Ehf | K252330 | OLZ |
| 2025-10-03 | xvision Spine system | Augmedics, Ltd. | K251639 | SBF |
| 2025-09-29 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | K252054 | SBF |
| 2025-09-11 | Mazor X System / Mazor X Stealth Edition | Mazor Robotics Ltd. | K251316 | OLO |
| 2025-07-01 | Felix NeuroAI System | Fasikl Incorporated | K250096 | QBC |
| 2025-06-20 | TMINI Miniature Robotic System | THINK Surgical, Inc. | K250877 | OLO |
| 2025-06-19 | EpiMonitor | Empatica Srl | K250515 | POS |
| 2025-05-16 | OTS Hip | Ortoma AB | K250086 | OLO |
| 2025-04-11 | Canvas Dx | Cognoa, Inc. | K243558 | QPF |
| 2025-04-09 | autoSCORE (V 2.0.0) | Holberg EEG AS | K243743 | OMB |
| 2025-03-26 | EarliPoint System | EarliTec Diagnostics | K243891 | QPF |
| 2025-03-14 | DeepRESP | Nox Medical ehf | K241960 | OLZ |
| 2025-03-13 | xvision Spine system | Augmedics Ltd. | K250255 | SBF |
| 2025-02-20 | Falcon HST | Compumedics Limited | K242447 | OLV |
| 2025-01-24 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | K243657 | HAW |
| 2025-01-13 | ARVIS® Shoulder | Kico Knee Innovation Company Pty Ltd | K243950 | SBF |
| 2025-01-06 | TMINI Miniature Robotic System | THINK Surgical, Inc. | K243481 | OLO |
| 2024-12-27 | FLASH EVD System (10-0002) | 7D Surgical ULC | K242480 | HAW |
| 2024-11-26 | NeuroMatch | LVIS Corporation | K241390 | OMB |
| 2024-11-22 | Dreem 3S | Beacon Biosignals, Inc. | K242094 | OLZ |
| 2024-10-17 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc | K240408 | OMB |
| 2024-10-16 | xvision Spine System | Augmedics Ltd. | K241481 | SBF |
| 2024-09-27 | encevis (2.1) | AIT Austrian Institute of Technology GmbH | K240993 | OMB |
| 2024-04-29 | ARVIS® Shoulder | Insight Medical Systems, Inc. | K240062 | OLO |
| 2024-04-03 | Oxevision Sleep Device | Oxehealth Limited | K233618 | LEL |
| 2024-03-20 | Automatic Registration | Brainlab AG | K234047 | OLO |
| 2024-03-11 | OTS Hip | Ortoma AB | K232140 | OLO |
| 2024-03-08 | SleepStageML | Beacon Biosignals, Inc. | K233438 | OLZ |
| 2024-02-15 | EpiMonitor | Empatica Srl | K232915 | POS |
| 2024-01-11 | BrainSee | Darmiyan, Inc. | DEN220066 | QWT |
| 2024-01-07 | autoSCORE | Holberg EEG AS | K231068 | OMB |
| 2024-01-03 | REMI AI Discrete Detection Module | Epitel, Inc. | K231779 | OMB |
| 2023-11-27 | ClearPoint System (Software Version 2.2) | ClearPoint Neuro Inc. | K233243 | HAW |
| 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 | HAW |
| 2023-08-18 | Dreem 3S | Beacon Biosignals, Inc. | K223539 | OLZ |
| 2023-08-02 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab AG | K223553 | OLO |
| 2023-07-21 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Brainlab AG | K223288 | HAW |
| 2023-06-29 | EarliPoint | EarliTec Diagnostics, Inc | K230337 | QPF |
| 2023-05-23 | Ceribell Status Epilepticus Monitor | Ceribell, Inc. | K223504 | OMB |
| 2023-04-27 | ENT EM | Brainlab AG | K223734 | PGW |
| 2023-04-19 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab AG | K223552 | HAW |
| 2023-03-17 | NeuroRPM | New Touch Digital Inc. | K221772 | GYD |
| 2023-01-11 | Alpha Control Liner System (ACLS) | Coapt | K223738 | GXY |
| 2022-09-21 | SomnoMetry | Neumetry Medical Inc | K221179 | OLZ |
| 2022-06-08 | EarliPoint System | EarliTec Diagnostics, Inc. | K213882 | QPF |
| 2021-10-02 | EYE-SYNC | SyncThink, Inc. | K202927 | QEA |
| 2021-06-16 | EnsoSleep | EnsoData, Inc. | K210034 | OLZ |
| 2021-06-02 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | DEN200069 | QPF |
| 2020-09-06 | EyeBOX | Oculogica, Inc. | K201841 | QEA |
| 2019-11-27 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical Inc. | K192945 | HAW |
| 2019-09-11 | BrainScope TBI | BrainScope Company, Inc. | K190815 | PIW |
| 2019-09-04 | Myo Plus | Otto Bock Healthcare Products GmbH | K191179 | GXY |
| 2019-07-31 | EyeBOX | Oculogica, Inc. | K191183 | QEA |
| 2019-05-24 | COMPLETE CONTROL System Gen2 | Coapt, LLC | K191083 | GXY |
| 2018-12-28 | EyeBOX | Oculogica, Inc. | DEN170091 | QEA |
| 2018-12-20 | Embrace | Empatica Srl | K181861 | POS |
| 2018-11-29 | Persyst 14 EEG Review and Analysis Software | Persyst Development Corporation | K182181 | OMB |
| 2018-10-05 | Sense System with IBT Electrodes | Infinite Biomedical Technologies, LLC | K182112 | GXY |
| 2018-09-28 | RightEye Vision System | RightEye, LLC | K181771 | GWN |
| 2018-06-29 | NuVasive Pulse System | NuVasive, Incorporated | K180038 | OLO |
| 2016-09-22 | Ahead 300 | BRAINSCOPE COMPANY INC | K161068 | PIW |
| 2015-05-15 | Brainscope Ahead 200 | BRAINSCOPE COMPANY, INC. | K143643 | PIW |
| 2014-11-17 | BrainScope Ahead 100 | BRAINSCOPE COMPANY, INC | DEN140025 | PIW |
Methods
Source file: FDA's AI-Enabled Medical Device List CSV (fda.gov/media/178541), 1614 rows, content current as of 09/04/2026, downloaded 2026-10-27. Filter: "Panel (Lead)" equals "Neurology". Pathway inferred from the submission number prefix (K = 510(k), DEN = De Novo, P = PMA). Devices reviewed under another lead panel (e.g., Radiology for brain imaging software) are not included. Submission links go to FDA's 510(k), De Novo and PMA databases.