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
Clever One
Ewoosoft Co., Ltd
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Healthcare GmbH
Sourced from FDA AI listRadiologyuMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyAVIEW
Coreline Soft Co., Ltd.
Sourced from FDA AI listRadiologyNemoScan
Software Nemotec S.L.
Sourced from FDA AI listRadiologyQT Scanner 2000 Model A
QT Imaging Holdings, Inc.
Sourced from FDA AI listRadiologyMagnifico Open (100009900)
Esaote, S.p.A.
Sourced from FDA AI listRadiologyDM-Density
Densitas, Inc.
Sourced from FDA AI listRadiologyIllumeo System
Philips Medical Systems Technologies, Ltd.
Sourced from FDA AI listCardiologyWAVE Clinical Platform
Excel Medical Electronics, LLC
Sourced from FDA AI listRadiologycNeuro cMRI
Combinostics Oy
Sourced from FDA AI listRadiologyS-scan Open (100001800)
Esaote, S.p.A.
Sourced from FDA AI listRadiologyQuantib Brain
Quantib BV
Sourced from FDA AI listRadiologyBunkerhill Contrast AVC
BunkerHill Health
Sourced from FDA AI listRadiologyiQMR
Medic Vision - Imaging Solutions Ltd
Sourced from FDA AI listRadiologyArterys Oncology DL
Arterys Inc.
Sourced from FDA AI listRadiologyRadiomics App v1.0
Microsoft Corp.
Sourced from FDA AI listRadiologyDR 800 with MUSICA Dynamic
Agfa HealthCare N.V.
Sourced from FDA AI listRadiologyEFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.AI, Co., Ltd.
Sourced from FDA AI listCardiologySPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
SPECTRALMD, INC.
Sourced from FDA AI listRadiologysyngo Application Software
Siemens Medical Solutions, USA, Inc.
Sourced from FDA AI listRadiologyQuantra
HOLOGIC, INC.
Sourced from FDA AI listlaboratory_medicineAdvanced RBC Application
Cella Vision AB
Sourced from FDA AI listRadiologySmartTarget
SmartTarget, Ltd.
Sourced from FDA AI listResults powered by Typesense.