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
Assert-IQ (DM5100)
Abbott Medical
Sourced from FDA AI listRadiologyCT VScore+
Canon Medical Informatics, Inc.
Sourced from FDA AI listRadiologyPrecise Position
Philips Healthcare (Suzhou) Co., Ltd.
Sourced from FDA AI listRadiologyOEC One CFD
Ge Hualun Medical Systems Co. , Ltd.
Sourced from FDA AI listRadiology7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Esaote, S.P.A.
Sourced from FDA AI listRadiologySynapse 3D Base Tools (V7.2)
Fujifilm Corporation
Sourced from FDA AI listRadiologyCartesion Prime (PCD-1000A/3) V10.21
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyFetal EchoScan (v1.2)
Brightheart
Sourced from FDA AI listRadiologyLOGIQ E10s
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyFibresolve (with PCCP)
Imvaria, Inc.
Sourced from FDA AI listRadiologySugarBug (1.x)
Bench7, Inc.
Sourced from FDA AI listRadiologyMAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd.
Sourced from FDA AI listRadiologyLOGIQ E10
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyAutoDensity
Eos Imaging
Sourced from FDA AI listRadiologyDeepHealth ProstateAI
Quantib B.V.
Sourced from FDA AI listRadiologyDTX Studio Assist
Nobel Biocare C/O Medicim NV
Sourced from FDA AI listRadiologySecond Opinion® Panoramic
Pearl, Inc.
Sourced from FDA AI listRadiologyCeevra Reveal 3+
Ceevra, Inc.
Sourced from FDA AI listRadiologyBunkerhill MAC
Bunkerhill Health
Sourced from FDA AI listRadiologyVisage Breast Density
Visage Imaging GmbH
Sourced from FDA AI listRadiologyX9 Ultrasound System
X9, Inc.
Sourced from FDA AI listRadiologyViz Subdural+, Viz SUBDURAL PLUS
Viz.ai, Inc.
Sourced from FDA AI listRadiologyAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
Canon Medical Systems Corporation
Sourced from FDA AI listNeurologyxvision Spine system
Augmedics, Ltd.
Sourced from FDA AI listResults powered by Typesense.