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
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Brainlab AG
Sourced from FDA AI listlaboratory_medicineDario Blood Glucose Monitoring System
LabStyle Innovations Ltd.
Sourced from FDA AI listRadiologysyngo.via RT Image Suite VC10
Varian Medical Systems, Inc.
Sourced from FDA AI listRadiologySOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listanesthesiologySnoreSounds
APPIAN MEDICAL, INC.
Sourced from FDA AI listRadiologyTrue Definition DL
Ge Healthcare Japan Corporation
Sourced from FDA AI listRadiologyCT Rembra RT; CT Areta RT; CT Rembra
Philips Healthcare (Suzhou) Co., Ltd.
Sourced from FDA AI listCardiologyLINQ II Insertable Cardiac Monitor
Medtronic, Inc.
Sourced from FDA AI listNeurologyENT EM
Brainlab AG
Sourced from FDA AI listRadiologyO-arm O2 Imaging System
Medtronic Navigation, Inc
Sourced from FDA AI listRadiologyIRIS INTELLIGENT RETINAL IMAGING SYSTEM
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
Sourced from FDA AI listRadiologyTrinias
Shimadzu Corporation
Sourced from FDA AI listanesthesiologyEndoTool SubQ
MONARCH MEDICAL TECHNOLOGIES
Sourced from FDA AI listRadiologyLung Density Analysis
IMBIO LLC
Sourced from FDA AI listRadiologyCVI42
CIRCLE CARDIOVASCULAR IMAGING INC
Sourced from FDA AI listRadiologyVoluson Expert 18; Voluson Expert 20; Voluson Expert 22
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologycvi42 Coronary Plaque Software Application
Circle Cardiovascular Imaging, Inc.
Sourced from FDA AI listRadiologyYSIO MAX
SIEMENS MEDICAL SOLUTIONS USA, INC.
Sourced from FDA AI listlaboratory_medicineUNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
BECKMAN COULTER, INC.
Sourced from FDA AI listRadiologyCLEARREAD +CONFIRM
RIVERAIN TECHNOLOGIES
Sourced from FDA AI listCardiologySENSICARDIAC
DIACOUSTIC MEDICAL (PTY)
Sourced from FDA AI listRadiologyALPHAPOINT IMAGING SOFTWARE
RADLOGICS, INC.
Sourced from FDA AI listNeurologyStealth AXiS Cranial clinical application
Medtronic Navigation, Inc.
Sourced from FDA AI listlaboratory_medicineKidneyIntelX.dkd
Renalytix AI, Inc.
Sourced from FDA AI listResults powered by Typesense.