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
uAI Easy Triage ICH
Shanghai United Imaging Intelligence Co., Ltd.
Sourced from FDA AI listRadiologyCuraRad-ICH
CuraCloud Corp.
Sourced from FDA AI listRadiologysyngo.CT Lung CAD
Siemens Medical Solutions, Inc
Sourced from FDA AI listRadiologyRed Dot
Behold.AI Technologies Limited
Sourced from FDA AI listRadiologyEchoConfidence (USA)
Mycardium AI Limited
Sourced from FDA AI listRadiologyBriefCase-Quantification
Aidoc Medical, Ltd.
Sourced from FDA AI listRadiologyBlineSlide
Deep Breathe, Inc.
Sourced from FDA AI listgastroenterology_urologyMaestro System (REF100)
Moon Surgical
Sourced from FDA AI listRadiologyTempus Pixel
Arterys, Inc.
Sourced from FDA AI listRadiologySMART PCFD
Disior Ltd
Sourced from FDA AI listRadiologyQLAB Advanced Quantification Software
Philips Healthcare
Sourced from FDA AI listRadiologyOverjet CBCT Assist
Overjet, Inc.
Sourced from FDA AI listRadiologybrAIn Shoulder Positioning
Avatar Medical
Sourced from FDA AI listRadiologyMAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyPhilips CT 3500
Philips Healthcare (Suzhou) Co., Ltd
Sourced from FDA AI listRadiologyEchoGo Core
Ultromics Ltd
Sourced from FDA AI listlaboratory_medicineAPAS Independence with Urine Analysis Module
Clever Culture Systems AG
Sourced from FDA AI listRadiologyMammoScreen BD
Therapixel
Sourced from FDA AI listRadiologyVoxel Dosimetry (00859873006226)
Hermes Medical Solutions AB
Sourced from FDA AI listRadiologyRho
16 Bit Inc
Sourced from FDA AI listRadiologyuOmnispace.MR
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyPowerLook Tomo Detection V2 Software
iCAD Inc.
Sourced from FDA AI listRadiologyCINA-iPE
Avicenna.AI
Sourced from FDA AI listRadiologyTruSPECT Processing Station
Spectrum Dynamics Medical, Ltd.
Sourced from FDA AI listResults powered by Typesense.