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
Revolution Vibe
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyNeuro Insight V1.0
Olea Medical S.A.S.
Sourced from FDA AI listRadiologyGyriCalc (Version 1.0.0)
NeuroSpectrum Insights Corp.
Sourced from FDA AI listCardiologyTempus ECG-Low EF
Tempus AI, Inc.
Sourced from FDA AI listRadiologyLUMINOS Q.namix T; LUMINOS Q.namix R
Siemens Medical Solutions
Sourced from FDA AI listRadiologyVivid Pioneer
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listCardiologyEko Foundation Analysis Software with Transformers (EFAST)
Eko Health, Inc.
Sourced from FDA AI listRadiologyuMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyuMR Ultra
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyTAVIPILOT
Caranx Medical
Sourced from FDA AI listRadiologyOPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
ABBOTT MEDICAL
Sourced from FDA AI listRadiologyMorph
BeauBrain Healthcare, Inc.
Sourced from FDA AI listRadiologyOncospace
Oncospace, Inc.
Sourced from FDA AI listRadiology6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Esaote S.p.A.
Sourced from FDA AI listRadiologyMAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
Siemens Healthcare GmbH
Sourced from FDA AI listCardiologyWithings ECG App
Withings
Sourced from FDA AI listRadiologyAurora
GE Medical Systems Israel
Sourced from FDA AI listRadiologySecond Opinion® CS
Pearl Inc.
Sourced from FDA AI listRadiologyBrightHeart View Classifier
BrightHeart
Sourced from FDA AI listCardiologyPhysCade System
PhysCade, Inc.
Sourced from FDA AI listRadiologyIngenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listlaboratory_medicineLensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
Bonraybio Co., LTD.
Sourced from FDA AI listRadiologyuOmnispace.MR
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyVoluson Performance 16; Voluson Performance 18
GE Medical Systems Ultrasound and Primary care Diagnostics
Sourced from FDA AI listResults powered by Typesense.