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
ArteraAI Breast
Artera, Inc.
Editorial summaryEmergency MedicineEFAI ERSuite CT Appendicitis Assessment System
Ever Fortune.AI Co., Ltd.
Editorial summaryUltrasoundARTHUR
ROPCA ApS
Editorial summaryRadiologyBriefCase ICH
Aidoc Medical
Sourced from FDA AI listRadiologyBriefCase PE
Aidoc Medical
Sourced from FDA AI listRadiologyIncisive Smart Workflow
Philips
Sourced from FDA AI listUltrasoundCaption Interpretation
GE HealthCare (Caption Health)
Editorial summaryObstetrics / GynecologySonoCNS Fetal Brain
GE HealthCare
Sourced from FDA AI listOphthalmologyEyeLook Glaucoma
Digital Diagnostics
Sourced from FDA AI listEndoscopyCADU
Olympus Corporation (Odin Medical Ltd.)
Editorial summaryRadiation OncologyRayStation Deep Learning Segmentation
RaySearch Laboratories
Editorial summaryRadiologyAutomation Platform
Canon Medical Systems
Sourced from FDA AI listEndoscopySMARTIBD
Olympus Corporation (Odin Medical Ltd.)
Editorial summaryRadiologyPrognica DenseBreast AI
Prognica Labs
Sourced from FDA AI listOncologyFlywheel Oncology Planner
Flywheel
Sourced from FDA AI listDermatologyNia Eczema Coach
Nia Health
Sourced from FDA AI listPrimary CareBabylon Symptom Checker
eMed / Babylon Health
Sourced from FDA AI listRadiologyWorkflow Box
Mirada Medical Ltd.
Sourced from FDA AI listRadiologyBrainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
Brainlab AG
Sourced from FDA AI listRadiologyBrainomix 360 Triage LVO
Brainomix Limited
Sourced from FDA AI listRadiologyCritical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyEFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune AI Co., Ltd.
Sourced from FDA AI listRadiologyDrAid for Radiology v1
VinBrain Joint Stock Company
Sourced from FDA AI listRadiologycvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging Inc
Sourced from FDA AI listResults powered by Typesense.