FDA-cleared AI devices for neurology 2023
2023 has 11 neurology AI devices, 450% more than 2022 (2). That is 15.1% of the 73 neurology devices on the FDA list, and 4.9% of all AI-device decisions dated 2023. The most active were Brainlab AG (5), Beacon Biosignals, Inc. (1), Ceribell, Inc. (1). The newest is ClearPoint System (Software Version 2.2) from ClearPoint Neuro Inc., decided on November 27, 2023.
Companies in 2023
By month
Product codes
HAWNeurological Stereotaxic Instrument4GXYElectrode, Cutaneous1GYDTransducer, Tremor1OLOOrthopedic Stereotaxic Instrument1OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph1OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph1PGWEar, Nose, And Throat Stereotaxic Instrument1QPFPediatric Autism Spectrum Disorder Diagnosis Aid1All 11 devices
- ClearPoint System (Software Version 2.2)ClearPoint Neuro Inc. · Neurology
- Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AG · Neurology
- Dreem 3SBeacon Biosignals, Inc. · Neurology
- Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG · Neurology
- Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIBrainlab AG · Neurology
- EarliPointEarliTec Diagnostics, Inc · Neurology
- Ceribell Status Epilepticus MonitorCeribell, Inc. · Neurology
- ENT EMBrainlab AG · Neurology
- Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning CranialBrainlab AG · Neurology
- NeuroRPMNew Touch Digital Inc. · Neurology
- Alpha Control Liner System (ACLS)Coapt · Neurology
Frequently asked questions
How many FDA-cleared AI neurology devices were there in 2023?
11 AI-enabled neurology devices have a final decision dated 2023, from 7 companies.
How does 2023 compare with 2022 for AI neurology devices?
2023 has 11 neurology AI devices, 450% more than 2022 (2).
Which companies cleared the most AI neurology devices in 2023?
Brainlab AG (5), Beacon Biosignals, Inc. (1), Ceribell, Inc. (1).
What was the most recent AI neurology device in 2023?
ClearPoint System (Software Version 2.2) from ClearPoint Neuro Inc. (K233243), decided on November 27, 2023. Product code HAW.
Which product codes were most common for AI neurology devices in 2023?
HAW (Neurological Stereotaxic Instrument): 4; GXY (Electrode, Cutaneous): 1; GYD (Transducer, Tremor): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for neurology 2023,” https://ai-device-radar.vercel.app/specialty/neurology/2023 (FDA list through 2026-06-29).