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
Acumen Hypotension Prediction Index (HPI) Feature Software
Edwards Lifesciences LLC
Sourced from FDA AI listOtherTyto Insights for Eardrum Bulging Detection
Tyto Care , Ltd.
Sourced from FDA AI listRadiologyAutoContour (RADAC V5)
Radformation, Inc.
Sourced from FDA AI listCardiologyPersonalized Physiology Analytics Engine software
VGBio, Inc (DBA PhysIQ)
Sourced from FDA AI listlaboratory_medicineVITEK MS
BIOMERIEUX, INC.
Sourced from FDA AI listclinical_toxicologyTISSUE OF ORIGIN TEST KIT FFPE
PATHWORK DIAGNOSTICS, INC.
Sourced from FDA AI listclinical_toxicologyPATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
PATHWORK DIAGNOSTICS, INC.
Sourced from FDA AI listRadiologyJLK-NCCT
JLK, Inc.
Sourced from FDA AI listRadiologyAiORTA - Plan v2.0
ViTAA Medical Solutions, Inc.
Sourced from FDA AI listRadiologyClarius Bladder AI
Clarius Mobile Health Corp.
Sourced from FDA AI listCardiologySignalHF (IM008)
Implicity Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.
Sourced from FDA AI listRadiologyVUNO Med-DeepBrain
VUNO Inc.
Sourced from FDA AI listRadiologyAxial3D Insight
Axial Medical Printing Limited
Sourced from FDA AI listRadiologyVelacur
Sonic Incytes
Sourced from FDA AI listRadiologyQOCA image Smart CXR Image Processing System
Quanta Computer Inc.
Sourced from FDA AI listRadiologyAVIEW RT ACS
Coreline Soft Co.,Ltd
Sourced from FDA AI listRadiologyqCT LN Quant
Qure.ai Technologies
Sourced from FDA AI listRadiologyEchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologyProstatID
ScanMed, LLC
Sourced from FDA AI listRadiologyAplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Canon Medical Systems Corporation
Sourced from FDA AI listNeurologyAlignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Brainlab AG
Sourced from FDA AI listRadiologyEFAI RTSuite CT HN-Segmentation System
Ever Fortune.AI Co., Ltd.
Sourced from FDA AI listRadiologyMRCAT Head & Neck
Philips Oy
Sourced from FDA AI listResults powered by Typesense.