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
Assert-IQ (DM5100)
Abbott Medical
Sourced from FDA AI listRadiologyNeosoma Brain Mets
Neosoma, Inc.
Sourced from FDA AI listRadiologyLumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Sourced from FDA AI listCardiologyIRNF App
Apple Inc.
Sourced from FDA AI listRadiologyVBrain-OAR
Vysioneer Inc.
Sourced from FDA AI listRadiologyBioticsAI
Bioticsai, Inc.
Sourced from FDA AI listanesthesiologySANSA HSAT
Huxley Medical
Sourced from FDA AI listRadiologyFetal EchoScan (v1.2)
Brightheart
Sourced from FDA AI listanesthesiologyPersonalized Therapy Comfort Settings (PTCS)
ResMed Corp
Sourced from FDA AI listRadiologyCartesion Prime (PCD-1000A/3) V10.21
Canon Medical Systems Corporation
Sourced from FDA AI listRadiologyCT VScore+
Canon Medical Informatics, Inc.
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 listPathologyGenius Digital Diagnostics System with the Genius Cervical AI algorithm
Hologic Inc.
Sourced from FDA AI listRadiologyUs2.v1
eko.ai Pte. Ltd. d/b/a Us2.ai
Sourced from FDA AI listgastroenterology_urologyGI Genius
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listRadiologyPrecise Position
Philips Healthcare (Suzhou) Co., Ltd.
Sourced from FDA AI listgastroenterology_urologyGastric Alimetry
Alimetry , Ltd.
Sourced from FDA AI listRadiologyCeevra Reveal 3+
Ceevra, Inc.
Sourced from FDA AI listRadiologyMAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd.
Sourced from FDA AI listRadiologyDTX Studio Assist
Nobel Biocare C/O Medicim NV
Sourced from FDA AI listRadiologyAutoDensity
Eos Imaging
Sourced from FDA AI listRadiologySecond Opinion® Panoramic
Pearl, Inc.
Sourced from FDA AI listRadiologySugarBug (1.x)
Bench7, Inc.
Sourced from FDA AI listResults powered by Typesense.