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
Arterys MICA
Arterys Inc.
Sourced from FDA AI listRadiologyViz ANEURYSM, Viz ANX
Viz.ai, Inc.
Sourced from FDA AI listRadiologyDeep Learning Image Reconstruction for Gemstone Spectral Imaging
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyAnnalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd
Sourced from FDA AI listRadiologyECHELON Synergy MRI System
FUJIFILM Healthcare Corporation
Sourced from FDA AI listanesthesiologyHuxley SANSA Home Sleep Apnea Test (1000-00)
Huxley Medical
Sourced from FDA AI listRadiologyRelu Creator
Relu BV
Sourced from FDA AI listRadiologyBU-CAD
TaiHao Medical Inc.
Sourced from FDA AI listRadiologyHealthPPT
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyOnQ Neuro
CorTechs Labs, Inc
Sourced from FDA AI listRadiologyLimbus Contour
Limbus AI Inc.
Sourced from FDA AI listRadiologyKoios DS
Koios Medical, Inc.
Sourced from FDA AI listgastroenterology_urologyEndoScreener
Chengdu Wision Medical Device Co., LTD.
Sourced from FDA AI listRadiologyTEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co.,LTD
Sourced from FDA AI listRadiologyHERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyEzra Flash
Ezra AI, Inc.
Sourced from FDA AI listRadiologyBrainomix 360 e-ASPECTS
Brainomix Limited
Sourced from FDA AI listRadiologyAdvanced Algorithms for Treatment Management Applications (AATMA)
Elekta Solutions AB
Sourced from FDA AI listRadiologyVantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyART-Plan+ (v3.1.0)
Therapanacea Sas
Sourced from FDA AI listRadiologyAIR Recon DL
Ge Medical Systems, LLC
Sourced from FDA AI listgastroenterology_urologySKOUT system
Iterative Health
Sourced from FDA AI listCardiologyeMurmur Heart AI
Csd Labs
Sourced from FDA AI listRadiologyPVAD IQ Software
Ultrasight , Ltd.
Sourced from FDA AI listResults powered by Typesense.