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
RhythmAnalytics
Biofourmis Singapore Pte. Ltd.
Sourced from FDA AI listRadiologyCentricity Universal Viewer
GE Healthcare
Sourced from FDA AI listCardiologyFFRct
HeartFlow, Inc
Sourced from FDA AI listRadiologyAMRA Profiler
AMRA Medical AB
Sourced from FDA AI listRadiologyVitrea CT Brain Perfusion
Vital Images, Inc.
Sourced from FDA AI listCardiologyCardio-TriTest v6.5
Cardio-Phoenix Inc.
Sourced from FDA AI listCardiologyAI-ECG Platform
Shenzhen Carewell Electronics., Ltd
Sourced from FDA AI listlaboratory_medicineAthelas One
Athelas Inc.
Sourced from FDA AI listRadiologyVivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologyMAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Siemens Shenzhen Magnetic Resonance , Ltd.
Sourced from FDA AI listRadiologyAplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation
Sourced from FDA AI listNeurologyPersyst 14 EEG Review and Analysis Software
Persyst Development Corporation
Sourced from FDA AI listCardiologyFibriCheck
Qompium nv
Sourced from FDA AI listRadiologyQuantitative Total Extensible Imaging (QTxI)
AIQ Solutions, Inc.
Sourced from FDA AI listlaboratory_medicineDIP/U.S. Urine Analysis Test System
Healthy.io Ltd
Sourced from FDA AI listRadiologyUscan
EchoNous, Inc.
Sourced from FDA AI listRadiologyDenSeeMammo
Statlife
Sourced from FDA AI listRadiologyEchoMD Automated Ejection Fraction Software
Bay Labs, Inc.
Sourced from FDA AI listNeurologyRightEye Vision System
RightEye, LLC
Sourced from FDA AI listCardiologyZio AT ECG Monitoring System, ZEUS System
iRhythm Technologies, Inc.
Sourced from FDA AI listRadiologyHealthCCS
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyLungQ Software
Thirona Corporation
Sourced from FDA AI listgastroenterology_urologyTransEnterix Senhance Surgical System
TransEnterix, Inc.
Sourced from FDA AI listRadiologyIngenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listResults powered by Typesense.