FDA-cleared AI devices for neurology 2026
2026 is still in progress (FDA decisions through June 29, 2026): 8 neurology AI devices so far, against 19 in all of 2025. That is 11% of the 73 neurology devices on the FDA list, and 4.4% of all AI-device decisions dated 2026. The most active were Medtronic Navigation, Inc. (2), Alphatec Spine, Inc. (1), Earlitec Diagnostics (1). The newest is SOMNUM (SOMNUM) from Honeynaps Co., Ltd., decided on June 27, 2026.
Companies in 2026
By month
Product codes
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2GWFStimulator, Electrical, Evoked Response1GXYElectrode, Cutaneous1HAWNeurological Stereotaxic Instrument1OLOOrthopedic Stereotaxic Instrument1QPFPediatric Autism Spectrum Disorder Diagnosis Aid1SIGTranscranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)1All 8 devices
- SOMNUM (SOMNUM)Honeynaps Co., Ltd. · Neurology
- MeRT SystemWave Neuroscience · Neurology
- myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)Otto Bock Healthcare Products GmbH · Neurology
- Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · Neurology
- Onera SleepMap (SLEEPMAP)Onera B.V. · Neurology
- EarliPoint AssessmentEarlitec Diagnostics · Neurology
- Stealth AXiS Surgical System with Stealth AXiS Spine clinical applicationMedtronic Navigation, Inc. · Neurology
- SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. · Neurology
Frequently asked questions
How many FDA-cleared AI neurology devices were there in 2026?
Through June 29, 2026, 8 AI-enabled neurology devices have a 2026 decision. That is 11% of all 73 neurology devices on the list.
How does 2026 compare with 2025 for AI neurology devices?
2026 is still in progress (FDA decisions through June 29, 2026): 8 neurology AI devices so far, against 19 in all of 2025.
Which companies cleared the most AI neurology devices in 2026?
Medtronic Navigation, Inc. (2), Alphatec Spine, Inc. (1), Earlitec Diagnostics (1).
What was the most recent AI neurology device in 2026?
SOMNUM (SOMNUM) from Honeynaps Co., Ltd. (K253390), decided on June 27, 2026. Product code OLZ.
Which product codes were most common for AI neurology devices in 2026?
OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph): 2; GWF (Stimulator, Electrical, Evoked Response): 1; GXY (Electrode, Cutaneous): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for neurology 2026,” https://ai-device-radar.vercel.app/specialty/neurology/2026 (FDA list through 2026-06-29).