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
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyAngioWaveNet
Angiowave Imaging, Inc.
Sourced from FDA AI listRadiologyRapid SDH
iSchemaView, Inc.
Sourced from FDA AI listRadiologyEFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyqXR-CTR
Qure.ai Technologies
Sourced from FDA AI listRadiologyqXR-PTX-PE
Qure.ai Technologies
Sourced from FDA AI listRadiologyBladder AI (AIBV01)
Exo Inc
Sourced from FDA AI listNeurologyCeribell Status Epilepticus Monitor
Ceribell, Inc.
Sourced from FDA AI listRadiologyVEA Align; spineEOS
EOS imaging
Sourced from FDA AI listRadiologyHealthJOINT
Zebra Medical Vision Ltd.
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 listRadiologyFormus Hip
Formus Labs, Ltd
Sourced from FDA AI listCardiologyAvive Automated External Defibrillator (AED) System
Avive Solutions, Inc.
Sourced from FDA AI listRadiologyViz LVO ContaCT
Viz.ai, Inc.
Sourced from FDA AI listRadiologyNinesMeasure
Nines, Inc.
Sourced from FDA AI listRadiologyEFAI NeuroSuite CT ICH Assessment System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyBrainomix 360 Triage ICH
Brainomix Limited
Sourced from FDA AI listRadiologyUltraSight AI Guidance
UltraSight Inc.
Sourced from FDA AI listRadiologyFEops HEARTguideTM, FEops HEARTguideTM ALPACA
FEops nv
Sourced from FDA AI listRadiologyVoluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
GE Healthcare
Sourced from FDA AI listRadiologyVantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyAVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd.
Sourced from FDA AI listResults powered by Typesense.