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
NEVISENSE
SCIBASE AB
Sourced from FDA AI listRadiologyPhotonova Spectra, Photonova Spectra Select
Ge Medical Systems, LLC
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 listCardiologyTyto Stethoscope (G3)
Tyto Care , Ltd.
Sourced from FDA AI listRadiologyContour+ (MVision AI Segmentation)
MVision AI Oy
Sourced from FDA AI listCardiologyPeerbridge Cor(TM) System
Peerbridge Health INc.
Sourced from FDA AI listRadiologyClearView cCAD
ClearView Diagnostics Inc.
Sourced from FDA AI listCardiologyTyto Stethoscope
Tyto Care Ltd.
Sourced from FDA AI listRadiologyArterys Cardio DL
ARTERYS INC.
Sourced from FDA AI listRadiologyLVivo Software Application
DIACARDIO, LTD.
Sourced from FDA AI listCardiologyReveal LINQ
Medtronic, Inc.
Sourced from FDA AI listlaboratory_medicineOne Drop Blood Glucose Monitoring System
AgaMatrix, Inc.
Sourced from FDA AI listRadiologyCT CoPilot
ZEPMED, LLC.
Sourced from FDA AI listRadiologyPixelShine
ALGOMEDICA
Sourced from FDA AI listRadiologyClearRead CT
RIVERAIN TECHNOLOGIES, LLC
Sourced from FDA AI listRadiologySaige-Dx
DeepHealth, Inc.
Sourced from FDA AI listRadiologyQVCAD System
QView Medical, Inc.
Sourced from FDA AI listRadiologyIRISeg
Intuitive Surgical, Inc.
Sourced from FDA AI listRadiologyBunkerhill Contrast CAC
BunkerHill Health
Sourced from FDA AI listRadiologyUltraSight Guidance
Ultrasight , Ltd.
Sourced from FDA AI listRadiologyLiverMultiScan (v6.0)
Perspectum, Ltd.
Sourced from FDA AI listRadiologyQuantib Brain 1
QUANTIB BV
Sourced from FDA AI listRadiologySIGNA Prime Elite
GE Medical Systems, LLC
Sourced from FDA AI listResults powered by Typesense.