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
MammoScreen® (5)
Therapixel
Sourced from FDA AI listRadiologyuCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyqXR-BT
Qure.ai Technologies
Sourced from FDA AI listRadiologyLVivo Seamless
DiA Imaging Analysis Ltd
Sourced from FDA AI listRadiologyAl-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyEnhanced Boundary for PCCT
Ge Medical Systems, LLC
Sourced from FDA AI listRadiologySecond Opinion
Pearl Inc.
Sourced from FDA AI listCardiologyIM007
Implicity, Inc.
Sourced from FDA AI listRadiologyFlightPlan for Liver
GE Medical Systems SCS
Sourced from FDA AI listRadiologyAlturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Sourced from FDA AI listRadiologySwoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
Sourced from FDA AI listRadiologySoteria.AI
Omega Medical Imaging, LLC
Sourced from FDA AI listRadiologyHeartFocus
Deski
Sourced from FDA AI listRadiologyBrainomix 360 Hyperdensity
Brainomix Limited
Sourced from FDA AI listRadiologySubtlePET
Subtle Medical, Inc.
Sourced from FDA AI listRadiologyVersana Premier
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologyV8 Diagnostic Ultrasound System
Samsung Medison CO., LTD.
Sourced from FDA AI listRadiologyDiscovery MI Gen2
GE Medical Systems, LLC.
Sourced from FDA AI listRadiologyIntelligent NR
Canon Inc.
Sourced from FDA AI listRadiologyHERA W9, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyRayStation 11.0
RaySearch Laboratories AB (publ)
Sourced from FDA AI listRadiologyAI Segmentation
Varian Medical Systems, Inc.
Sourced from FDA AI listRadiologyAuto Lung Nodule Detection
Samsung Electronics Co.,Ltd.
Sourced from FDA AI listRadiologyRBknee
Radiobotics ApS
Sourced from FDA AI listResults powered by Typesense.