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
OncoStudio (OS-01)
OncoSoft. Co., Ltd.
Sourced from FDA AI listRadiologyDV. Target
Deepvoxel INC
Sourced from FDA AI listRadiologyuAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.
Sourced from FDA AI listRadiologyQFR (3.0)
QFR Solutions bv
Sourced from FDA AI listRadiologyEFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.
Sourced from FDA AI listRadiologyHealthMammo
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologya2z-Unified-Triage
A2z Radiology Ai, Inc.
Sourced from FDA AI listRadiologyCardiac Guidance
Caption Health, Inc.
Sourced from FDA AI listRadiologyInfinitt PACS 7.0
Infinitt Healthcare Co.,Ltd.
Sourced from FDA AI listRadiologyEFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Ever Fortune.AI, Co., Ltd.
Sourced from FDA AI listNeurologyBrainSee
Darmiyan, Inc.
Sourced from FDA AI listRadiologyContour ProtégéAI+
MIM Software Inc.
Sourced from FDA AI listgastroenterology_urologyNaviCam ProScan
Ankon Technologies co., ltd
Sourced from FDA AI listRadiologyTEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Sourced from FDA AI listRadiologyAccipiolx
MaxQ Al Ltd.
Sourced from FDA AI listRadiologyNinesAI
Nines, Inc.
Sourced from FDA AI listRadiologyAIMI-Triage CXR PTX
RADLogics, Inc.
Sourced from FDA AI listRadiologyJLK-ICH
JLK, Inc.
Sourced from FDA AI listRadiologyCaption Interpretation Automated Ejection Fraction Software
Caption Health, Inc
Sourced from FDA AI listObstetrics / GynecologyKIDScore D3
Vitrolife A/S
Sourced from FDA AI listRadiologyDeepCT
Deep01 Limited
Sourced from FDA AI listRadiologySmartChest
Milvue
Sourced from FDA AI listCardiologySignalHF (IM008)
Implicity Inc.
Sourced from FDA AI listRadiologySonix Health
Ontact Health Co., Ltd.
Sourced from FDA AI listResults powered by Typesense.