AI medical devices
A neutral, evidence-based catalogue. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.
Editor's Picks
The devices we'd point a colleague to first.
Aidoc
Aidoc Medical
The most-deployed AI radiology platform in 2026 — multi-pathology CT triage with the longest production track record.
CADDIE
Olympus Corporation (Odin Medical Ltd.)
First RCT-grade evidence in colonoscopy AI — the EAGLE 2026 trial.
Caption AI
GE HealthCare (Caption Health)
Bringing point-of-care echocardiography to non-cardiologists. The first FDA-cleared assistive AI for image acquisition.
HeartFlow FFRCT Analysis
HeartFlow, Inc.
Non-invasive coronary FFR. PMA-grade evidence accumulated over a decade of clinical use.
LumineticsCore
Digital Diagnostics (formerly IDx Technologies)
First autonomous AI diagnostic ever cleared in the United States — diabetic retinopathy at the point of care.
Paige Prostate Detect
Paige.AI (acquired by Tempus AI, August 2025)
First FDA-authorized pathology AI — and a study reference for what "computer-aided" means in 2026 practice.
Of 1,358FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1358 devices
CT 5300
Philips Healthcare (Suzhou) Co., Ltd.
Sourced from FDA AI listRadiologysyngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listlaboratory_medicineAUTION EYE AI-4510 Urine Particle Analysis System
Arkray Inc.
Sourced from FDA AI listRadiologyRelu Cloud
Relu BV
Sourced from FDA AI listRadiologyTrue Enhance DL
GE Healthcare Japan Corporation
Sourced from FDA AI listNeurologyOxevision Sleep Device
Oxehealth Limited
Sourced from FDA AI listRadiologysyngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyAquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyNAEOTOM Alpha
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listCardiologyNovasight Hybrid System
Conavi Medical, Inc.
Sourced from FDA AI listCardiologyEko Low Ejection Fraction Tool (ELEFT)
Eko Health, Inc.
Sourced from FDA AI listRadiologyOverjet Caries Assist-Pediatric
Overjet, Inc
Sourced from FDA AI listRadiologysyngo Dynamics (VA41F)
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyMAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyMAGNETOM Terra; MAGNETOM Terra.X
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH
Sourced from FDA AI listNeurologyAutomatic Registration
Brainlab AG
Sourced from FDA AI listRadiologyCINA-ASPECTS
Avicenna.AI
Sourced from FDA AI listNeurologySleepStageML
Beacon Biosignals, Inc.
Sourced from FDA AI listNeurologymyosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
Otto Bock Healthcare Products GmbH
Sourced from FDA AI listRadiologyEdgeFlow UH10
Edgecare Inc.
Sourced from FDA AI listRadiologyEdgeFlow UW20
Edgecare, Inc.
Sourced from FDA AI listRadiologyHealthFLD
Nano-X AI Ltd.
Sourced from FDA AI listRadiologyCEPHX- Cephalometric Analysis Software
Orca Dental AI LTD
Sourced from FDA AI listResults powered by Typesense.