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
Al-Rad Companion (Musculoskeletal)
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyAVIEW LCS
Coreline Soft Co., Ltd
Sourced from FDA AI listRadiologySonoVision Ultrasound Imaging System
Tissue Differentiation Intelligence, LLC
Sourced from FDA AI listCardiologySafeBeat Rx App
SafeBeat Rx, Inc.
Sourced from FDA AI listRadiologyuMR 780
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listRadiologyAutomated Aortic Stenosis Software (AutoAS)
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Sourced from FDA AI listRadiologySIGNA Premier
GE Healthcare (GE Medical Systems, LLC)
Sourced from FDA AI listCardiologyBodyGuardian Remote Monitoring System
Preventice Technologies, Inc.
Sourced from FDA AI listRadiologyAquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologydensitas densityai
Densitas, Inc.
Sourced from FDA AI listRadiologyBiograph Vision, Biograph mCT Family of PET/CTs
Siemens Medical Solutions USA, Inc
Sourced from FDA AI listRadiologyBiograph Horizon
Siemens Medical Solution USA, Inc.
Sourced from FDA AI listNeurologySpineAR SNAP (SyncAR Spine)
Surgical Theater, Inc.
Sourced from FDA AI listRadiologyEthos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Varian Medical Systems, Inc.
Sourced from FDA AI listRadiologyBroncholab
Fluidda Inc.
Sourced from FDA AI listRadiologyicobrain-ctp
Icometrix NV
Sourced from FDA AI listRadiologyMRCAT brain
Philips Medical Systems MR Finland
Sourced from FDA AI listCardiologyStudy Watch with Irregular Pulse Monitor
Verily Life Sciences LLC
Sourced from FDA AI listRadiologyAuto Positioning
GE Hangwei Medical Systems, Co., Ltd.
Sourced from FDA AI listCardiologyKneevoice Cartilage Evaluation System (750-3600-001)
Kneevoice, Inc.
Sourced from FDA AI listRadiologyAV Cardiac CT
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyLOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listCardiologyMIMOSA Imager
MIMOSA Diagnostics Inc
Sourced from FDA AI listlaboratory_medicineSight OLO
Sight Diagnostics Ltd.
Sourced from FDA AI listResults powered by Typesense.