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
OrthoNext Platform System
Orthofix Srl
Sourced from FDA AI listRadiologyStrain AI (SAI001)
Exo Inc
Sourced from FDA AI listRadiologySubtleSYNTH (1.x)
Subtle Medical, Inc.
Sourced from FDA AI listNeurologyOTS Hip
Ortoma AB
Sourced from FDA AI listRadiologyHealthJOINT
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyAI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.
Sourced from FDA AI listNeurologyREMI-AI Rapid Detection Module (REMI-AI RDM)
Epitel, Inc
Sourced from FDA AI listRadiologyqER
Qure.ai Technologies
Sourced from FDA AI listRadiologyDrAid for Liver Segmentation
VinBrain Joint Stock Company
Sourced from FDA AI listRadiologyEchoMeasure
iCardio.ai
Sourced from FDA AI listRadiologyiCAS-LV
HighRAD Ltd.
Sourced from FDA AI listgastroenterology_urologyGI Genius
Cosmo Artificial Intelligence - AI, LTD
Sourced from FDA AI listRadiologyuOmnispace.CT
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listRadiologyPIUR tUS Infinity
PIUR Imaging GmbH
Sourced from FDA AI listCardiologyeCARTv5 Clinical Deterioration Suite (eCART)
AgileMD, Inc.
Sourced from FDA AI listNeurologyAlignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Brainlab AG
Sourced from FDA AI listRadiologyCaption Guidance
Bay Labs, Inc.
Sourced from FDA AI listRadiologySMART Bun-Yo-Matic X-Ray
Disior Ltd
Sourced from FDA AI listRadiologyImbio PHA (4.0.0)
Imbio, Inc
Sourced from FDA AI listRadiologyLVivo IQS
DiA Imaging Analysis Ltd.
Sourced from FDA AI listRadiologyAuto Segmentation
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyAquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyCareverse CoronaryDoc (Careverse CoronaryDoc)
Careverse Technology Pte. Ltd.
Sourced from FDA AI listCardiologyLoss of Pulse Detection
Fitbit
Sourced from FDA AI listResults powered by Typesense.