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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
RayStation 11B
RaySearch Laboratories AB (publ)
Sourced from FDA AI listRadiologyINT Contour
Carina Medical LLC
Sourced from FDA AI listRadiologyUltrasound Workspace (UWS 6.0)
Philips Ultrasound LLC
Sourced from FDA AI listRadiologyMAGNETOM Vida with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVoluson P6, Voluson P8
GE Healthcare
Sourced from FDA AI listRadiologyRevolution Ascend
GE Healthcare Japan Corporation
Sourced from FDA AI listRadiologyMicro C Medical Imaging System, M01
OXOS Medical, Inc.
Sourced from FDA AI listRadiologyqXR-Detect
Qure.Ai Technologies
Sourced from FDA AI listRadiologySIGNA Hero
GE Healthcare (GE Medical Systems, LLC)
Sourced from FDA AI listRadiologyDeep Learning Image Reconstruction
GE Medical Systems, LLC.
Sourced from FDA AI listRadiologyQuantib ND
Quantib B.V.
Sourced from FDA AI listRadiologySIGNA Prime
GE Healthcare (Tianjin) Company Limited
Sourced from FDA AI listRadiologyPrecise Image
Philips Medical Systems Nederland, B.V.
Sourced from FDA AI listRadiologyEclipse II with Smart Noise Cancellation
Carestream Health, Inc.
Sourced from FDA AI listRadiologyuCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
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 listRadiologyCydar EV (Series B) and Cydar EV Maps
Cydar Ltd.
Sourced from FDA AI listRadiologyqXR-BT
Qure.ai Technologies
Sourced from FDA AI listRadiologyUNiD Spine Analyzer
MEDICREA International, Inc.
Sourced from FDA AI listRadiologySecond Opinion
Pearl Inc.
Sourced from FDA AI listRadiologySwoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
Sourced from FDA AI listRadiologySubtlePET
Subtle Medical, Inc.
Sourced from FDA AI listRadiologySoteria.AI
Omega Medical Imaging, LLC
Sourced from FDA AI listResults powered by Typesense.