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
xT CDx
Tempus Labs, Inc.
Sourced from FDA AI listRadiologyACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVoluson Signature 20, Voluson Signature 18
GE Medical Systems Ultrasound and Primary care Diagnostics,
Sourced from FDA AI listRadiologyqXR-PTX-PE
Qure.ai Technologies
Sourced from FDA AI listRadiologyVEA Align; spineEOS
EOS imaging
Sourced from FDA AI listRadiologyqXR-CTR
Qure.ai Technologies
Sourced from FDA AI listRadiologyBladder AI (AIBV01)
Exo Inc
Sourced from FDA AI listclinical_toxicologyPATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
PATHWORK DIAGNOSTICS
Sourced from FDA AI listRadiologyFormus Hip
Formus Labs, Ltd
Sourced from FDA AI listRadiologyNinesMeasure
Nines, Inc.
Sourced from FDA AI listCardiologyCleerly ISCHEMIA
Cleerly, Inc
Sourced from FDA AI listRadiologyAnnalise Enterprise CTB Triage-OH
Annalise-AI Pty Ltd
Sourced from FDA AI listRadiologyCerebralGo Plus
Yukun (Beijing) Technology Co., Ltd
Sourced from FDA AI listRadiologyFEops HEARTguideTM, FEops HEARTguideTM ALPACA
FEops nv
Sourced from FDA AI listRadiologyDeep Learning Image Reconstruction
GE Healthcare Japan Corporation
Sourced from FDA AI listRadiologyAVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd.
Sourced from FDA AI listRadiologyUltraSight AI Guidance
UltraSight Inc.
Sourced from FDA AI listRadiologyuCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyAcorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
Sourced from FDA AI listRadiologyVUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Vuno Inc.
Sourced from FDA AI listNeurologySense System with IBT Electrodes
Infinite Biomedical Technologies, LLC
Sourced from FDA AI listRadiologyAVIEW
Coreline Soft Co.,Ltd.
Sourced from FDA AI listRadiologyCINA
AVICENNA.AI
Sourced from FDA AI listRadiologyCS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
Omega Medical Imaging, LLC
Sourced from FDA AI listResults powered by Typesense.