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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
MAGENTIQ-COLO (ME-APDS)
Magentiq Eye LTD
Sourced from FDA AI listRadiologyPrenuvo Body Composition
Prenuvo
Sourced from FDA AI listRadiologySecond Opinion CC
Pearl Inc.
Sourced from FDA AI listNeurologyARVIS® Shoulder
Kico Knee Innovation Company Pty Ltd
Sourced from FDA AI listRadiologyDigital Color Doppler Ultrasound System (P60 Series)
Sonoscape Medical Corp.
Sourced from FDA AI listRadiologyuCT 780
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyuCT 550
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listNeurologyClearPoint System (Software Version 3.0)
ClearPoint Neuro, Inc.
Sourced from FDA AI listRadiologyMSKai
MSKai
Sourced from FDA AI listCardiologyVolta AF-Xplorer
Volta Medical
Sourced from FDA AI listRadiologyClarify DL
GE Medical Systems Israel, Functional Imaging
Sourced from FDA AI listNeurologyFLASH EVD System (10-0002)
7D Surgical ULC
Sourced from FDA AI listRadiologyAquilion ONE (TSX-308A/3) V1.5
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyIQ-UIP
Imbio, Inc.
Sourced from FDA AI listRadiologyuMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co.,Ltd.
Sourced from FDA AI listclinical_toxicologyBIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
BIO-RAD LABORATORIES, INC.
Sourced from FDA AI listRadiologyLightning Viewer
Nexsys Electronics Inc. dba Medweb
Sourced from FDA AI listRadiologyClearRead CT CAC
Riverain Technologies, Inc.
Sourced from FDA AI listCardiologyInformed Vital Core Application (IVC App)
Mindset Medical, Inc.
Sourced from FDA AI listRadiology1CMR Pro
Mycardium AI Limited
Sourced from FDA AI listRadiologyicobrain aria
icometrix NV
Sourced from FDA AI listRadiologyThe 5000 Compact Series Ultrasound Systems
Philips Ultrasound LLC
Sourced from FDA AI listRadiologynordicMEDiVA
NordicNeurolab AS
Sourced from FDA AI listRadiologycvi42 Software Application
Circle Cardiovascular Imaging Inc.
Sourced from FDA AI listResults powered by Typesense.