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
Rayvolve
AZmed SAS
Sourced from FDA AI listRadiologyHealthVCF
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologySee-Mode Augmented Reporting Tool, Thyroid (SMART-T)
See-Mode Technologies Pte. Ltd.
Sourced from FDA AI listRadiologyPreview Shoulder
Genesis Software Innovations
Sourced from FDA AI listRadiologyAnnalise Enterprise
Harrison-AI Medical Pty, Ltd.
Sourced from FDA AI listRadiologyJBS-LVO
JLK, Inc.
Sourced from FDA AI listRadiologycmTriage
CureMetrix, Inc
Sourced from FDA AI listRadiologyAnnalise Enterprise CXR Triage Trauma
Annalise-AI Pty Ltd
Sourced from FDA AI listRadiologySaige-Dx
DeepHealth, Inc.
Sourced from FDA AI listgeneral_plastic_surgeryDermaSensor
DermaSensor Inc.
Sourced from FDA AI listCardiologyFFRct
HEARTFLOW, INC.
Sourced from FDA AI listCardiologySteth IO
STRATOSCIENTIFIC, INC.
Sourced from FDA AI listgastroenterology_urologyCADDIE
Odin Medical Limited
Sourced from FDA AI listRadiologyBriefCase-Triage
Aidoc Medical , Ltd.
Sourced from FDA AI listRadiologyARTAssistant
Manteia Technologies Co., Ltd.
Sourced from FDA AI listRadiologyVentripoint Medical System Plus (VMS+) 4.0
Ventripoint Diagnostics Ltd.
Sourced from FDA AI listOphthalmologyNotal Vision Home Optical Coherence Tomography (OCT) System
Notal Vision Inc
Sourced from FDA AI listNeurologyBrainScope Ahead 100
BRAINSCOPE COMPANY, INC
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 listRadiologyDeepContour (V1.0)
Wisdom Technologies., Inc.
Sourced from FDA AI listRadiologyQP-Brain®
Quibim S.L.
Sourced from FDA AI listRadiologyBraveCX
Bering Ltd
Sourced from FDA AI listlaboratory_medicineKidneyIntelX.dkd
Renalytix AI, Inc.
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 listResults powered by Typesense.