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
Careverse CoronaryDoc (Careverse CoronaryDoc)
Careverse Technology Pte. Ltd.
Sourced from FDA AI listRadiologyV5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listCardiologyLoss of Pulse Detection
Fitbit
Sourced from FDA AI listCardiologyGlobal Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC
Sourced from FDA AI listRadiologyHepaFatSmart (V2.0.0)
Resonance Health Analysis Services Pty Ltd
Sourced from FDA AI listRadiologyTAIMedImg DeepMets
Taiwan Medical Imaging Co., Ltd.
Sourced from FDA AI listRadiologyRadiography 7300 C
Philips Medical Systems DMC GmbH
Sourced from FDA AI listCardiologySamsung ECG Monitor Application with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd
Sourced from FDA AI listRadiologyPhilips CT 3500
Philips Healthcare (Suzhou) Co., Ltd
Sourced from FDA AI listRadiologyMAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listCardiologyEmpatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Empatica S.R.L.
Sourced from FDA AI listCardiologyIrregular Rhythm Notification Feature (IRNF)
Apple Inc.
Sourced from FDA AI listRadiologyUltrasound System 2300
BK Medical Aps
Sourced from FDA AI listRadiologyRadioLens v1.0
Synapsica
Sourced from FDA AI listRadiologySOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologySalix Coronary Plaque (V1.0.0)
Artrya Limited
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 listRadiologyACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
Siemens Medical Solutions, USA, Inc.
Sourced from FDA AI listRadiologySoteria E-View
Omega Medical Imaging, LLC
Sourced from FDA AI listOphthalmologyEyeArt v2.2.0
Eyenuk, Inc.
Sourced from FDA AI listPathologyxT CDx
Tempus Labs, Inc.
Sourced from FDA AI listRadiologyBriefCase
Aidoc Medical, Ltd.
Sourced from FDA AI listRadiologyAngioWaveNet
Angiowave Imaging, Inc.
Sourced from FDA AI listRadiologyACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listResults powered by Typesense.