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
APPRAISE-HRI
The Surgeon General, Department of the Army (TSG-DA)
Sourced from FDA AI listgastroenterology_urologyGI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listRadiologyDASI Dimensions (V1.0)
DASI Simulations
Sourced from FDA AI listRadiologyConstellation (CON-001)
Q Bio, Inc.
Sourced from FDA AI listRadiologyStrain AI (SAI001)
Exo Inc
Sourced from FDA AI listNeurologyREMI-AI Rapid Detection Module (REMI-AI RDM)
Epitel, Inc
Sourced from FDA AI listNeurologyOTS Hip
Ortoma AB
Sourced from FDA AI listRadiologyOrthoNext Platform System
Orthofix Srl
Sourced from FDA AI listRadiologySubtleSYNTH (1.x)
Subtle Medical, Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.
Sourced from FDA AI listRadiologyiCAS-LV
HighRAD Ltd.
Sourced from FDA AI listanesthesiologySleep Apnea Feature
Samsung Electronics Co., Ltd
Sourced from FDA AI listRadiologyDrAid for Liver Segmentation
VinBrain Joint Stock Company
Sourced from FDA AI listRadiologyEchoMeasure
iCardio.ai
Sourced from FDA AI listRadiologyPIUR tUS Infinity
PIUR Imaging GmbH
Sourced from FDA AI listCardiologyeCARTv5 Clinical Deterioration Suite (eCART)
AgileMD, Inc.
Sourced from FDA AI listRadiologyuOmnispace.CT
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyOverjet Image Enhancement Assist
Overjet Inc
Sourced from FDA AI listRadiologyImbio PHA (4.0.0)
Imbio, Inc
Sourced from FDA AI listRadiologySMART Bun-Yo-Matic X-Ray
Disior Ltd
Sourced from FDA AI listRadiologyLVivo IQS
DiA Imaging Analysis Ltd.
Sourced from FDA AI listRadiologyAuto Segmentation
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyDeepFoqus (DeepFoqus-Accelerate)
Foqus Technologies Inc.
Sourced from FDA AI listRadiologyAI-Rad Companion (Musculoskeletal)
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listResults powered by Typesense.