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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Medtronic, Inc.
Sourced from FDA AI listRadiologySIGNA 7.0T
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyHYPER AiR
Shanghai United Imaging Healthcare Co.,Ltd.
Sourced from FDA AI listRadiologyCT Cardiomegaly
Innolitics, LLC
Sourced from FDA AI listRadiologyOptellum Virtual Nodule Clinic, Optellum software, Optellum platform
Optellum Ltd
Sourced from FDA AI listRadiologyMaxFOV 2
GE Medical Systems, LLC.
Sourced from FDA AI listRadiologySubtleMR
Subtle Medical, Inc.
Sourced from FDA AI listRadiologyMAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyAquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyViz HDS, Viz Volume Plus, Viz ICH+
Viz.ai, Inc.
Sourced from FDA AI listRadiologyImbio RV/LV Software
Imbio, LLC
Sourced from FDA AI listRadiologyQUIBIM Precision Prostate (qp-Prostate)
QUIBIM S.L.
Sourced from FDA AI listRadiologyAquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyAI Metrics
AI Metrics, LLC
Sourced from FDA AI listRadiologyHepaFat-AI
Resonance Health Analysis Services Pty Ltd
Sourced from FDA AI listRadiologyVantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyEchoGo Pro
Ultromics Ltd
Sourced from FDA AI listCardiologyVital Signs
Oxehealth Limited
Sourced from FDA AI listRadiologyHepatica v1 (Hepatica v1.0.0)
Perspectum Ltd.
Sourced from FDA AI listRadiologyAquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Canon Medical Systems Corporation
Sourced from FDA AI listCardiologyCLEWICU System (ClewICUServer and ClewICUnitor)
CLEW Medical Ltd.
Sourced from FDA AI listRadiologyBrainInsight
Hyperfine Research, Inc
Sourced from FDA AI listRadiologySynapse 3D, Synapse 3D Base Tools v6.1
Fujifilm Corporation
Sourced from FDA AI listOrthopedicsSignature ONE System
Orthosoft Inc. (d/b/a) Zimmer CAS
Sourced from FDA AI listResults powered by Typesense.