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 1,304FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1304 devices
Impala
AliveCor, Inc.
Sourced from FDA AI listRadiologySyngo Carbon Enterprise Access (VA40A)
Siemens Healthcare GmbH
Sourced from FDA AI listdentalDentalMonitoring
Dental Monitoring SAS
Sourced from FDA AI listOrthopedicsUnited Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.
Sourced from FDA AI listRadiologyBriefCase-Triage
Aidoc Medical, Ltd.
Sourced from FDA AI listdentalRAYDENT SW
RAY Co., Ltd.
Sourced from FDA AI listRadiologyuMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listCardiologyASSURE Wearable ECG
Kestra Medical Technologies, Inc.
Sourced from FDA AI listRadiologyECHELON Synergy V10.0
Fujifilm Healthcare Americas Corporation
Sourced from FDA AI listRadiologyCT 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 listOphthalmologyAEYE-DS
AEYE Health Inc.
Sourced from FDA AI listRadiologyCardIQ Suite
GE Medical Systems SCS
Sourced from FDA AI listRadiologyART-Plan (v.2.2.0)
Therapanacea SAS
Sourced from FDA AI listRadiologyiQ-solutions
Sydney Neuroimaging Analysis Centre Pty Ltd
Sourced from FDA AI listRadiologyEthos Treatment Management (3.0); Ethos Treatment Planning (2.0)
Varian Medical Systems Inc.
Sourced from FDA AI listRadiologySmartChest
Milvue
Sourced from FDA AI listRadiologyTrue Enhance DL
GE Healthcare Japan Corporation
Sourced from FDA AI listNeurologyOxevision Sleep Device
Oxehealth Limited
Sourced from FDA AI listRadiologyAquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyUs2.v2
Eko.ai Pte. Ltd d/b/a Us2.ai
Sourced from FDA AI listRadiologyNAEOTOM Alpha
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listCardiologyEko Low Ejection Fraction Tool (ELEFT)
Eko Health, Inc.
Sourced from FDA AI listResults powered by Typesense.