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
Rooti Rx ECG Event Recorder, Rooti Link APP Software
Rooti Labs Ltd.
Sourced from FDA AI listRadiologycNeuro cMRI
Combinostics Oy
Sourced from FDA AI listRadiologyInfinitt PACS 7.0
Infinitt Healthcare Co.,Ltd.
Sourced from FDA AI listRadiologyAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Canon Medical Systems Corporation
Sourced from FDA AI listCardiologyPeerbridge Cor(TM) System
Peerbridge Health INc.
Sourced from FDA AI listlaboratory_medicineAdvanced RBC Application
Cella Vision AB
Sourced from FDA AI listgeneral_plastic_surgeryNEVISENSE
SCIBASE AB
Sourced from FDA AI listCardiologyCardioLogs ECG Analysis Platform
Cardiologs Technologies
Sourced from FDA AI listRadiologySmartTarget
SmartTarget, Ltd.
Sourced from FDA AI listRadiologyQuantra
HOLOGIC, INC.
Sourced from FDA AI listRadiologyBladderScan Prime PLUS System
Verathon Incorporated
Sourced from FDA AI listRadiologyClarius Ultrasound System
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyNeuroQuant
CorTechs Labs, Inc
Sourced from FDA AI listRadiologysyngo Application Software
Siemens Medical Solutions, USA, Inc.
Sourced from FDA AI listCardiologyTyto Stethoscope (G3)
Tyto Care , Ltd.
Sourced from FDA AI listRadiologyPhotonova Spectra, Photonova Spectra Select
Ge Medical Systems, LLC
Sourced from FDA AI listCardiologySPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
SPECTRALMD, INC.
Sourced from FDA AI listRadiologyLOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listlaboratory_medicineOne Drop Blood Glucose Monitoring System
AgaMatrix, Inc.
Sourced from FDA AI listRadiologyQVCAD System
QView Medical, Inc.
Sourced from FDA AI listCardiologyTyto Stethoscope
Tyto Care Ltd.
Sourced from FDA AI listRadiologyClearRead CT
RIVERAIN TECHNOLOGIES, LLC
Sourced from FDA AI listRadiologyPixelShine
ALGOMEDICA
Sourced from FDA AI listCardiologyFFRct
HEARTFLOW, INC.
Sourced from FDA AI listResults powered by Typesense.