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
CellaVision DC-1, CellaVision DC-1 PPA
CellaVision AB
Sourced from FDA AI listRadiologyAI Platform 2.2 (AIP002)
Exo Imaging
Sourced from FDA AI listRadiologySIGNA Artist
GE Healthcare (Tianjin) Company Limited
Sourced from FDA AI listRadiologyAVIEW
Coreline Soft Co., Ltd
Sourced from FDA AI listRadiologyAVA (Augmented Vascular Analysis)
See-Mode Technologies Pte. Ltd.
Sourced from FDA AI listRadiologyTHINQ
CorticoMetrics LLC
Sourced from FDA AI listRadiologyVivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyLunit INSIGHT DBT (V1.2)
Lunit, Inc.
Sourced from FDA AI listRadiologyCaption Guidance
Caption Health
Sourced from FDA AI listCardiologyVX1
Volta Medical
Sourced from FDA AI listNeurologyREMI AI Discrete Detection Module
Epitel, Inc.
Sourced from FDA AI listRadiologyVIDAvision
VIDA Diagnostics Inc.
Sourced from FDA AI listRadiologyVivid iq
GE Medical Systems Ultrasound and
Sourced from FDA AI listRadiologyAuto 3D Bladder Volume Tool
Butterfly Network, Inc.
Sourced from FDA AI listOphthalmologyEyeArt
Eyenuk, Inc
Sourced from FDA AI listRadiologyVivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyVantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyAI-Rad Companion Engine
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyDeep Recon
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologySeg Pro V3 (RT-300)
Ever Fortune.Ai, Co., Ltd.
Sourced from FDA AI listRadiologyIngenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyAI-Rad Companion Brain MR
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyHepatic VCAR
GE Medical Systems SCS
Sourced from FDA AI listCardiologyAI-ECG Tracker
Shenzhen Carewell Electronics Co., Ltd.
Sourced from FDA AI listResults powered by Typesense.