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
BoneMRI v1.6
MRIguidance B.V.
Sourced from FDA AI listNeurologyBrainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
Brainlab AG
Sourced from FDA AI listRadiologyViz LVO ContaCT
Viz.ai, Inc.
Sourced from FDA AI listRadiologyQOCA® image Smart RT Contouring System
Quanta Computer Inc.
Sourced from FDA AI listgastroenterology_urologyEW10-EC02 Endoscopy Support Program
FUJIFILM Corporation
Sourced from FDA AI listCardiologyStudy Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Verily Life Sciences LLC
Sourced from FDA AI listRadiologyFerriSmart Analysis System
Resonance Health Analysis Services Pty Ltd
Sourced from FDA AI listanesthesiologySleep Apnea Feature
Samsung Electronics Co., Ltd
Sourced from FDA AI listRadiologyEchoPAC Software Only, EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologySyngo Carbon Clinicals (VA41)
Siemens Healthineers AG
Sourced from FDA AI listRadiologyPIUR tUS inside
PIUR Imaging GmbH
Sourced from FDA AI listRadiologySaige-Density
DeepHealth, Inc.
Sourced from FDA AI listRadiologyFractureDetect (FX)
Imagen Technologies, Inc.
Sourced from FDA AI listRadiologyOnQ Neuro
CorTechs Labs, Inc
Sourced from FDA AI listRadiologyAnnalise Enterprise
Annalise-AI
Sourced from FDA AI listgastroenterology_urologyGI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listanesthesiologyTyto Insights for Rhonchi Detection
Tyto Care , Ltd.
Sourced from FDA AI listRadiologySecond Opinion® 3D
Pearl, Inc.
Sourced from FDA AI listRadiologyClarius Median Nerve AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyRayvolve PTX-PE
AZmed
Sourced from FDA AI listRadiologySaige-Dx
DeepHealth, Inc
Sourced from FDA AI listRadiologyTeraRecon Cardiac.Chambers.MR (1.0.0)
TeraRecon,Inc.
Sourced from FDA AI listRadiologyTranspara (2.1.0)
ScreenPoint Medical B.V.
Sourced from FDA AI listRadiologyProFound Detection (V4.0)
iCAD, Inc.
Sourced from FDA AI listResults powered by Typesense.