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
CaRi-Plaque
Caristo Diagnostics Ltd.
Sourced from FDA AI listanesthesiologyTipTraQ (TTQ001)
PranaQ Pte. Ltd.
Sourced from FDA AI listOrthopedicsMyShoulder Planner (5.3SSWPL)
Medacta International S.A.
Sourced from FDA AI listgeneral_plastic_surgeryCo-Ablation System with Sterile Co-Ablation Probe
Hygea Medical Technology Co., Ltd.
Sourced from FDA AI listRadiologyBunkerhill AVC
BunkerHill Health
Sourced from FDA AI listclinical_toxicologyPATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE
PATHWORK DIAGNOSTICS
Sourced from FDA AI listRadiologyVivid T9/Vivid T8
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listgastroenterology_urologyMAGENTIQ-COLO (ME-APDS)
Magentiq Eye LTD
Sourced from FDA AI listNeurologyClearPoint System (Software Version 3.0)
ClearPoint Neuro, Inc.
Sourced from FDA AI listNeurologyARVIS® Shoulder
Kico Knee Innovation Company Pty Ltd
Sourced from FDA AI listRadiologyRapid Neuro3D
iSchemaView, Inc.
Sourced from FDA AI listRadiologyDigital Color Doppler Ultrasound System (P60 Series)
Sonoscape Medical Corp.
Sourced from FDA AI listRadiologyPrenuvo Body Composition
Prenuvo
Sourced from FDA AI listRadiologyuCT 550
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listObstetrics / GynecologyPeriCALM Patterns 3.0
PeriGen, Inc.
Sourced from FDA AI listRadiologyuCT 780
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyRadify Triage
Envisionit DeepAI Ltd
Sourced from FDA AI listRadiologySecond Opinion CC
Pearl Inc.
Sourced from FDA AI listNeurologyFLASH EVD System (10-0002)
7D Surgical ULC
Sourced from FDA AI listRadiologyAquilion ONE (TSX-308A/3) V1.5
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyLightning Viewer
Nexsys Electronics Inc. dba Medweb
Sourced from FDA AI listRadiologyMSKai
MSKai
Sourced from FDA AI listRadiologyuMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Shanghai United Imaging Healthcare Co.,Ltd.
Sourced from FDA AI listRadiologyIQ-UIP
Imbio, Inc.
Sourced from FDA AI listResults powered by Typesense.