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
CLARUS (700)
Carl Zeiss Meditec, Inc.
Sourced from FDA AI listRadiologyRayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
RaySearch Laboratories AB (PUBL)
Sourced from FDA AI listRadiologyHi-D Imaging 4TAVR
Hi-D Imaging AG
Sourced from FDA AI listRadiologyTribusConnect
TribusMed Beheer BV
Sourced from FDA AI listRadiologyV5med Lung AI
V5med Inc.
Sourced from FDA AI listRadiologyRayvolve LN
AZmed
Sourced from FDA AI listNeurologyEarliPoint System
EarliTec Diagnostics
Sourced from FDA AI listOrthopedicsGoLIF! Lumbar Interbody Fusion System
GetSet Surgical, SA
Sourced from FDA AI listclinical_toxicologyTissue of Origin Test Kit-FFPE
Cancer Genetics, Inc.
Sourced from FDA AI listRadiologyHeartFocus (V.1.1.1)
Deski
Sourced from FDA AI listanesthesiologyAirmod
Heroic Faith International Ltd.
Sourced from FDA AI listRadiologyDEEPECHO
DeepEcho
Sourced from FDA AI listRadiologyChestView US
Gleamer SAS
Sourced from FDA AI listRadiologyaiCockpit AI Viewer
Fovia, Inc.
Sourced from FDA AI listRadiology3DXR
GE Medical Systems SCS
Sourced from FDA AI listdentalCEREC Ortho Software
Dentsply Sirona
Sourced from FDA AI listNeurologyxvision Spine system
Augmedics Ltd.
Sourced from FDA AI listRadiologyAmCAD-UV
AmCad BioMed Corporation
Sourced from FDA AI listOtherTriton System
GAUSS SURGICAL INC.
Sourced from FDA AI listRadiologyBetter Diagnostics Caries Assist (BDCA) Version 1.0
Better Diagnostics AI Corp
Sourced from FDA AI listRadiologyQuickRad
Aikenist Technologies Pvt Ltd
Sourced from FDA AI listNeurologyFalcon HST
Compumedics Limited
Sourced from FDA AI listRadiologyNAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVivid iq
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listResults powered by Typesense.