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 1,304FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1304 devices
CLEWICU System (ClewICUServer and ClewICUnitor)
CLEW Medical Ltd.
Sourced from FDA AI listOrthopedicsSignature ONE System
Orthosoft Inc. (d/b/a) Zimmer CAS
Sourced from FDA AI listRadiologySynapse 3D, Synapse 3D Base Tools v6.1
Fujifilm Corporation
Sourced from FDA AI listRadiologyBrainInsight
Hyperfine Research, Inc
Sourced from FDA AI listCardiologyVital Signs
Oxehealth Limited
Sourced from FDA AI listRadiologyQUIBIM Precision Prostate (qp-Prostate)
QUIBIM S.L.
Sourced from FDA AI listRadiologyVantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyAI Metrics
AI Metrics, LLC
Sourced from FDA AI listRadiologyEchoGo Pro
Ultromics Ltd
Sourced from FDA AI listRadiologyAquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyHepaFat-AI
Resonance Health Analysis Services Pty Ltd
Sourced from FDA AI listRadiologyAquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyHepatica v1 (Hepatica v1.0.0)
Perspectum Ltd.
Sourced from FDA AI listRadiologyFastStroke, CT Perfusion 4D
GE Medical Systems SCS
Sourced from FDA AI listlaboratory_medicineLensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
Bonraybio Co., Ltd.
Sourced from FDA AI listRadiologyA View LCS
Coreline Soft Co., Ltd.
Sourced from FDA AI listRadiologyPROView
GE Medical Systems SCS
Sourced from FDA AI listlaboratory_medicineCellaVision DC-1, CellaVision DC-1 PPA
CellaVision AB
Sourced from FDA AI listCardiologyKardiaAI
AliveCor, Inc.
Sourced from FDA AI listCardiologyStethee Pro 1, Stethee Pro Software System
M3DICINE Pty Ltd.
Sourced from FDA AI listlaboratory_medicineX100 with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs LTD.
Sourced from FDA AI listRadiologyLiverMultiScan
Perspectum LTD
Sourced from FDA AI listRadiologySIGNA Sprint Select
Ge Medical Systems, LLC
Sourced from FDA AI listRadiologySIGNA Bolt
Ge Medical Systems, LLC
Sourced from FDA AI listResults powered by Typesense.