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
InferRead Lung CT.AI
Beijing Infervision Technology Co.,Ltd.
Sourced from FDA AI listRadiologyRed Dot
Behold.AI Technologies Limited
Sourced from FDA AI listRadiologyCritical Care Suite
GE Medical Systems, LLC.
Sourced from FDA AI listRadiologyAccipiolx
MaxQ-Al Ltd.
Sourced from FDA AI listRadiologyVELYS Hip Navigation
Depuy Ireland UC
Sourced from FDA AI listRadiologyCDM Insights
Oxford Brain Diagnostics Ltd
Sourced from FDA AI listRadiologySonix Health
Ontact Health Co., Ltd.
Sourced from FDA AI listRadiologyMEDO ARIA
Medo.ai
Sourced from FDA AI listCardiologyFFRangio
CathWorks Ltd
Sourced from FDA AI listRadiologyKoios DS for Breast
Koios Medical, Inc.
Sourced from FDA AI listNeurologyOnera SleepMap (SLEEPMAP)
Onera B.V.
Sourced from FDA AI listRadiologyWorkflow Box
Mirada Medical Ltd.
Sourced from FDA AI listgeneral_plastic_surgeryDUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Dilon Medical Technologies, Ltd.
Sourced from FDA AI listRadiologyOverjet Dental Assist
Overjet, Inc.
Sourced from FDA AI listCardiologyAnalytic for Hemodynamic Instability (AHI)
Fifth Eye Inc.
Sourced from FDA AI listRadiologyAccipiolx
MaxQ Al Ltd.
Sourced from FDA AI listRadiologyRapid ICH
iSchemaView Incorporated
Sourced from FDA AI listRadiologyAccuContour
Xiamen Manteia Technology LTD.
Sourced from FDA AI listNeurologyNuVasive Pulse System
NuVasive, Incorporated
Sourced from FDA AI listRadiologySeg Pro V3 (RT-300)
Ever Fortune.Ai, Co., Ltd.
Sourced from FDA AI listgastroenterology_urologyDeep Capsule® (Deep Capsule US)
Digestaid - Artificial Intelligence Development SA
Sourced from FDA AI listRadiologyuAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.
Sourced from FDA AI listRadiologyImagio Breast Imaging System
Seno Medical Instruments, Inc.
Sourced from FDA AI listRadiologyHealthVCF
Zebra Medical Vision Ltd.
Sourced from FDA AI listResults powered by Typesense.