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
AiORTA - Plan v2.0
ViTAA Medical Solutions, Inc.
Sourced from FDA AI listRadiologyAxial3D Insight
Axial Medical Printing Limited
Sourced from FDA AI listRadiologyClarius Bladder AI
Clarius Mobile Health Corp.
Sourced from FDA AI listCardiologySignalHF (IM008)
Implicity Inc.
Sourced from FDA AI listRadiologyVelacur
Sonic Incytes
Sourced from FDA AI listgastroenterology_urologyGI Genius
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listRadiologyDV. Target
Deepvoxel INC
Sourced from FDA AI listRadiologyAI-Rad Companion Prostate MR
Siemens Medical Solutions USA Inc.
Sourced from FDA AI listRadiologyHealthMammo
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyNinesAI
Nines, Inc.
Sourced from FDA AI listRadiologyAccuContour
Xiamen Manteia Technology LTD.
Sourced from FDA AI listRadiologyHealthPNX
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyTranspara
ScreenPoint Medical BV
Sourced from FDA AI listRadiologyWorkflow Box
Mirada Medical Ltd.
Sourced from FDA AI listRadiologyOsteoDetect
Imagen Technologies, Inc.
Sourced from FDA AI listclinical_toxicologyTissue of Origin Test Kit-FFPE
Cancer Genetics, Inc.
Sourced from FDA AI listgeneral_plastic_surgeryDUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Dilon Medical Technologies, Ltd.
Sourced from FDA AI listRadiologyAplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Canon Medical Systems Corporation
Sourced from FDA AI listNeurologyAlignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Brainlab AG
Sourced from FDA AI listRadiologyArterys MICA
Arterys Inc.
Sourced from FDA AI listRadiologyECHELON Synergy MRI System
FUJIFILM Healthcare Corporation
Sourced from FDA AI listanesthesiologyHuxley SANSA Home Sleep Apnea Test (1000-00)
Huxley Medical
Sourced from FDA AI listRadiologyHealthPPT
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyOnQ Neuro
CorTechs Labs, Inc
Sourced from FDA AI listResults powered by Typesense.