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 1,358FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1358 devices
CASSIE
Wesper, Inc.
Sourced from FDA AI listRadiologyIntelligent NR
Canon, Inc.
Sourced from FDA AI listRadiologyMammoSightAI
Neurocareai, Inc. (Dba Savelife.Ai)
Sourced from FDA AI listRadiologyRevolution Ascend Sliding
GE Hangwei Medical Systems Co., Ltd.
Sourced from FDA AI listRadiologyVelmeni for Dentists (V4D) Endo-Perio
Velmeni, Inc.
Sourced from FDA AI listNeurologyEpiMonitor
Empatica Srl
Sourced from FDA AI listanesthesiologyAurora
EnsoData
Sourced from FDA AI listRadiologyLumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Sourced from FDA AI listCardiologyHeartFlow Analysis
HeartFlow, Inc.
Sourced from FDA AI listRadiologyYSIO X.pree
Siemens Medical Solutions
Sourced from FDA AI listRadiologyBiograph VK10
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyLungQ v3.0.0
Thirona BV
Sourced from FDA AI listRadiologyButterfly iQ3 Ultrasound System
Butterfly Network, Inc.
Sourced from FDA AI listRadiologyART-Plan
TheraPanacea
Sourced from FDA AI listRadiologyMAGNETOM Sola; MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologysyngo Application Software
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyBonelogic
Disior Ltd
Sourced from FDA AI listRadiologyDTX Studio Clinic (4.0)
Nobel Biocare AB
Sourced from FDA AI listRadiologyLOGIQ Totus
GE Medical Systems Ultrasound and Primary care Diagnostics,
Sourced from FDA AI listRadiologyMyocardial Strain Software Application
Circle Cardiovascular Imaging
Sourced from FDA AI listRadiologyuOmnispace.MI
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyMAGNETOM Cima.X
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVidea Dental Assist
VideaHealth, Inc.
Sourced from FDA AI listdentalLingOral Dental Design System
Hangzhou ChohoTech Co., Ltd.
Sourced from FDA AI listResults powered by Typesense.