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
CVI42
CIRCLE CARDIOVASCULAR IMAGING INC
Sourced from FDA AI listRadiologyVoluson Expert 18; Voluson Expert 20; Voluson Expert 22
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologycvi42 Coronary Plaque Software Application
Circle Cardiovascular Imaging, Inc.
Sourced from FDA AI listRadiologyTrue Definition DL
Ge Healthcare Japan Corporation
Sourced from FDA AI listCardiologySENSICARDIAC
DIACOUSTIC MEDICAL (PTY)
Sourced from FDA AI listRadiologyALPHAPOINT IMAGING SOFTWARE
RADLOGICS, INC.
Sourced from FDA AI listRadiologyMAGNETOM Amira; MAGNETOM Sempra
Siemens Medical Solutions USA Inc.
Sourced from FDA AI listNeurologyStealth AXiS Cranial clinical application
Medtronic Navigation, Inc.
Sourced from FDA AI listCardiologySENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
Sourced from FDA AI listlaboratory_medicineUNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
BECKMAN COULTER, INC.
Sourced from FDA AI listRadiologyYSIO MAX
SIEMENS MEDICAL SOLUTIONS USA, INC.
Sourced from FDA AI listRadiologyCLEARREAD +CONFIRM
RIVERAIN TECHNOLOGIES
Sourced from FDA AI listlaboratory_medicineMALDI BIOTYPER CA (MBT-CA) SYSTEM
BRUKER DALTONICS, INC
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Medical Solutions U.S.A.
Sourced from FDA AI listRadiologyVantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation
Sourced from FDA AI listObstetrics / GynecologyLUMA CERVICAL IMAGING SYSTEM
SPECTRA SCIENCE
Sourced from FDA AI listgeneral_plastic_surgeryMELAFIND
STRATA SKIN SCIENCES, INC.
Sourced from FDA AI listlaboratory_medicineCELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
CELLAVISION AB
Sourced from FDA AI listlaboratory_medicineCELLAVISION DM96 WITH THE BODY FLUID APPLICATION
CELLAVISION AB
Sourced from FDA AI listCardiologyVISENSIA
OBS MEDICAL
Sourced from FDA AI listRadiologysyngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyIB NEURO, VERSION 1.0
IMAGING BIOMETRICS, LLC
Sourced from FDA AI listRadiologysyngo.CT Coronary Cockpit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyDELTAVIEW MODEL 2.1
RIVERAIN MEDICAL GROUP,LLC
Sourced from FDA AI listResults powered by Typesense.