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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
KIDScore D3
Vitrolife A/S
Sourced from FDA AI listRadiologyCritical Care Suite with Endotracheal Tube Positing AI algorithm
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyBoneMRI
MRIguidance B.V
Sourced from FDA AI listRadiologyQOCA® image Smart RT Contouring System
Quanta Computer Inc.
Sourced from FDA AI listRadiologyRadify Triage
Envisionit DeepAI Ltd
Sourced from FDA AI listRadiologyAlzevita
TOPIA MEDTECH LIMITED
Sourced from FDA AI listRadiologyCleerly LABS (v2.0)
Cleerly, Inc.
Sourced from FDA AI listRadiologyOncoStudio (OS-01)
OncoSoft. Co., Ltd.
Sourced from FDA AI listgeneral_plastic_surgeryDermaSensor
DermaSensor Inc.
Sourced from FDA AI listRadiologyFibresolve
Imvaria, Inc
Sourced from FDA AI listRadiologyPeekMed web
Peek Health, S.A.
Sourced from FDA AI listRadiologyGBrain MRI
Galileo CDS, Inc
Sourced from FDA AI listNeurologyDeepRESP
Nox Medical Ehf
Sourced from FDA AI listRadiologyLigence Heart
Ligence, UAB
Sourced from FDA AI listRadiologyAVIEW CAC
Coreline Soft Co., Ltd.
Sourced from FDA AI listRadiologyAI-CVD
HeartLung Corporation
Sourced from FDA AI listRadiologyBrain WMH
Quantib BV
Sourced from FDA AI listRadiologyCINA-CSpine
Avicenna.AI
Sourced from FDA AI listNeurologyBrainSee
Darmiyan, Inc.
Sourced from FDA AI listPathologyINFINITT DPS
Infinitt Healthcare Co., Ltd.
Sourced from FDA AI listCardiologyCardioVision
Icardio.Ai
Sourced from FDA AI listNeurologyMazor X System / Mazor X Stealth Edition
Mazor Robotics Ltd.
Sourced from FDA AI listNeurologyEpiMonitor
Empatica Srl
Sourced from FDA AI listOrthopedicsUnited Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.
Sourced from FDA AI listResults powered by Typesense.