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
TruPlan
Circle Cardiovascular Imaging Inc.
Sourced from FDA AI listRadiologyiNtuition-Structural Heart Module
TeraRecon Inc.
Sourced from FDA AI listRadiologyLiverMultiScan (LMSv3)
Perspectum Diagnostics Ltd
Sourced from FDA AI listOphthalmologyCLARUS
Carl Zeiss Meditec, Inc
Sourced from FDA AI listRadiologyAquilion ONE (TSX-305A/6) V8.9 with AiCE
Canon Medical Systems Corporation
Sourced from FDA AI listCardiologyAcumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences, LLC
Sourced from FDA AI listCardiologyphysIQ Heart Rhythm and Respiratory Module
physIQ, Inc
Sourced from FDA AI listRadiologyVUNO Med-DeepBrain
VUNO Inc.
Sourced from FDA AI listRadiologyRayCare 2.3
RaySearch Laboratories AB (publ)
Sourced from FDA AI listRadiologyQuantib ND
Quantib BV
Sourced from FDA AI listRadiologyLung Vision System
Body Vision Medical Ltd.
Sourced from FDA AI listRadiologyBone VCAR (BVCAR)
GE Medical Systems SCS
Sourced from FDA AI listCardiologyStudy Watch
Verily Life Sciences LLC
Sourced from FDA AI listRadiologyMRCP+ v1.0
Perspectum Diagnostics Ltd
Sourced from FDA AI listCardiologyRhythmAnalytics
Biofourmis Singapore Pte. Ltd.
Sourced from FDA AI listanesthesiologyd-Nav System
Hygieia, Inc
Sourced from FDA AI listRadiologyCARA System
Cara Medical, Ltd.
Sourced from FDA AI listRadiologySecond Opinion® BLE
Pearl Inc.
Sourced from FDA AI listCardiologyeMurmur ID
CSD Labs GmbH
Sourced from FDA AI listCardiologyLoop System
Spry Health, Inc.
Sourced from FDA AI listRadiologyAmCAD-UO
AmCad BioMed Corporation
Sourced from FDA AI listCardiologyPreemptiveAI Clinical SDK
Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Sourced from FDA AI listlaboratory_medicineAthelas One
Athelas Inc.
Sourced from FDA AI listRadiologyVivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listResults powered by Typesense.