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
AV Vascular
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyHALO
NICo-Lab B.V.
Sourced from FDA AI listRadiologyCorInsights MRI
ADM Diagnostics, Inc.
Sourced from FDA AI listRadiologysyngo.via MI Workflows, syngo MBF
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyAVIEW RT ACS
Coreline Soft Co.,Ltd
Sourced from FDA AI listRadiologyTOMTEC-ARENA
TOMTEC Imaging Systems GmbH
Sourced from FDA AI listRadiologyOPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott Medical
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyuWS-MR
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listRadiologyViz ICH
Viz.ai, Inc.
Sourced from FDA AI listRadiologyPowerLook Density Assessment V4.0
iCAD, Inc.
Sourced from FDA AI listRadiologySaige-Q
DeepHealth, Inc.
Sourced from FDA AI listlaboratory_medicineAccelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc.
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes Ltd
Sourced from FDA AI listRadiologyAccipiolx
MaxQ-Al Ltd.
Sourced from FDA AI listRadiologyNeurophet AQUA AD Plus
Neurophet., Inc.
Sourced from FDA AI listNeurologyStealth AXiS Surgical System with Stealth AXiS Spine clinical application
Medtronic Navigation, Inc.
Sourced from FDA AI listNeurologyEYE-SYNC
SyncThink, Inc.
Sourced from FDA AI listgastroenterology_urologyGI Genius
Cosmo Artificial Intelligence - AI, LTD
Sourced from FDA AI listCardiologyAcumen Hypotension Prediction Index (HPI) Feature Software
Edwards Lifesciences LLC
Sourced from FDA AI listRadiologyMRCAT Head & Neck
Philips Oy
Sourced from FDA AI listRadiologyClariSIGMAM
ClariPi Inc.
Sourced from FDA AI listRadiologyMI View&GO
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyqER-Quant
Qure.ai Technologies
Sourced from FDA AI listResults powered by Typesense.