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
DeepCT
Deep01 Limited
Sourced from FDA AI listRadiologyPowerLook Tomo Detection V2 Software
iCAD Inc.
Sourced from FDA AI listNeurologyBrainscope Ahead 200
BRAINSCOPE COMPANY, INC.
Sourced from FDA AI listRadiologyRevealAI-Lung
Precision Medical Ventures, Inc. Dba Revealdx
Sourced from FDA AI listRadiologyAnnalise Enterprise
Harrison-AI Medical Pty, Ltd.
Sourced from FDA AI listNeurologyEarliPoint Assessment
Earlitec Diagnostics
Sourced from FDA AI listRadiologyEchoNavigator R5.0
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologySwiftMR
Airs Medical, Inc.
Sourced from FDA AI listCardiologyVivio® LVEDP System
Avicena, LLC
Sourced from FDA AI listRadiologyFerriSmart Analysis System
Resonance Health Analysis Services Pty Ltd
Sourced from FDA AI listRadiologyQuantX
Quantitative Insights, Inc
Sourced from FDA AI listRadiologyLunit INSIGHT DBT (V1.2)
Lunit, Inc.
Sourced from FDA AI listRadiologyAI4CMR v2.0
Ai4medimaging Medical Solutions S.A.
Sourced from FDA AI listNeurologyBrainScope TBI
BrainScope Company, Inc.
Sourced from FDA AI listlaboratory_medicineDreaMed Advisor Pro
DreaMed Diabetes, Ltd.
Sourced from FDA AI listRadiologyCEPHX3D
Orca Dental AI , Ltd.
Sourced from FDA AI listCardiologyECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
Sourced from FDA AI listNeurologyBrainScope Ahead 100
BRAINSCOPE COMPANY, INC
Sourced from FDA AI listRadiologyBriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
Aidoc Medical , Ltd.
Sourced from FDA AI listCardiologyJewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Element Science, Inc.
Sourced from FDA AI listNeurologyencevis (2.1)
AIT Austrian Institute of Technology GmbH
Sourced from FDA AI listRadiologyRapid (6.0)
iSchemaView, Inc.
Sourced from FDA AI listRadiologyContour ProtégéAI+
Mim Software, Inc.
Sourced from FDA AI listRadiologyZiostation2
Ziosoft, Inc.
Sourced from FDA AI listResults powered by Typesense.