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
RSI-MRI+
MultiModal Imaging Services Corporation (dba HealthLytix)
Sourced from FDA AI listRadiologyMEDIP PRO
MEDICALIP Co., Ltd
Sourced from FDA AI listRadiologyCleerly Labs
Cleerly Inc
Sourced from FDA AI listRadiologyQyScore Software
Qynapse
Sourced from FDA AI listRadiologyKOALA
IB Lab GmbH
Sourced from FDA AI listOtherWellDoc BlueStar
WellDoc, Inc.
Sourced from FDA AI listRadiologyIcobrain
Icometrix NV
Sourced from FDA AI listCardiologyMIMOSA Imager
MIMOSA Diagnostics Inc
Sourced from FDA AI listlaboratory_medicineSight OLO
Sight Diagnostics Ltd.
Sourced from FDA AI listRadiologyRTHawk, HeartVista Cardiac Package
HeartVista, Inc.
Sourced from FDA AI listRadiologyBriefCase-Triage: CARE Multi-triage CT Body
Aidoc Medical , Ltd.
Sourced from FDA AI listRadiologyDelivery Date AI
Ultrasound AI
Sourced from FDA AI listRadiologyD2P
3D Systems, Inc.
Sourced from FDA AI listCardiologyZio XT ECG Monitoring System, Zio AT ECG Monitoring System
iRhythm Technologies, Inc.
Sourced from FDA AI listCardiologyBiovitals Analytics Engine
Biofourmis Singapore Pte. Ltd
Sourced from FDA AI listRadiologyVentripoint Medical System Plus (VMS+) 3.0
Ventripoint Diagnostics, Ltd.
Sourced from FDA AI listCardiologyHeartFlow FFRct Analysis
HeartFlow, Inc.
Sourced from FDA AI listCardiologyPeraMobile and PeraWatch
PeraHealth, Inc.
Sourced from FDA AI listRadiologyaBSI
EXINI Diagnostics AB
Sourced from FDA AI listRadiologyAI-Rad Companion (Cardiovascular)
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listlaboratory_medicineACR LAB Urine Analysis Test System
Healthy.io Ltd
Sourced from FDA AI listNeurologyMyo Plus
Otto Bock Healthcare Products GmbH
Sourced from FDA AI listRadiologyRayCare 2.3
RaySearch Laboratories AB (publ)
Sourced from FDA AI listResults powered by Typesense.