Cardiology AI medical devices
A neutral, evidence-based catalogue of cardiology AI medical devices. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.
prolaio eVO2peak Module (Version 1.0)
Prolaio, Inc.
Sourced from FDA AI listCardiologyCardioVision
Icardio.Ai
Sourced from FDA AI listCardiologyECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
Sourced from FDA AI listCardiologyCorVista System with PH Add-On
Analytics for Life, Inc.
Sourced from FDA AI listCardiologyEchoGo Amyloidosis (1.0)
Ultromics Limited
Sourced from FDA AI listCardiologyAcumen Assisted Fluid Management (AFM) Software Feature
Edwards Lifesciences, LLC
Sourced from FDA AI listCardiologyTempus ECG-AF
Tempus AI, Inc.
Sourced from FDA AI listCardiologyAPPRAISE-HRI
The Surgeon General, Department of the Army (TSG-DA)
Sourced from FDA AI listCardiologyeCARTv5 Clinical Deterioration Suite (eCART)
AgileMD, Inc.
Sourced from FDA AI listCardiologyCLEWICU System
Clew Medical Ltd.
Sourced from FDA AI listCardiologyZEUS System
iRhythm Technologies, Inc.
Sourced from FDA AI listCardiologyZEUS System (Zio Watch)
iRhythm Technologies, Inc.
Sourced from FDA AI listCardiologyLoss of Pulse Detection
Fitbit
Sourced from FDA AI listCardiologyEmpatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Empatica S.R.L.
Sourced from FDA AI listCardiologySamsung ECG Monitor Application with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd
Sourced from FDA AI listCardiologyIrregular Rhythm Notification Feature (IRNF)
Apple Inc.
Sourced from FDA AI listCardiologyStudy Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
Verily Life Sciences LLC
Sourced from FDA AI listCardiologyGlobal Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC
Sourced from FDA AI listCardiologyCleerly ISCHEMIA
Cleerly, Inc
Sourced from FDA AI listCardiologyAvive Automated External Defibrillator (AED) System
Avive Solutions, Inc.
Sourced from FDA AI listCardiologyEko Analysis Software
Eko Devices Inc
Sourced from FDA AI listCardiologyDEEPVESSEL FFR
KeyaMed NA Inc.
Sourced from FDA AI listCardiologyOxehealth Vital Signs
Oxehealth Limited
Sourced from FDA AI listCardiologyCorVista® System
CorVista Health, Inc.
Sourced from FDA AI listCardiologyAHI System
Fifth Eye Inc.
Sourced from FDA AI listCardiologyFEops HEARTguide
FEops NV
Sourced from FDA AI listCardiologySaranas Early Bird Bleed Monitoring System
Saranas Inc.
Sourced from FDA AI listCardiologyGili Pro BioSensor (also known as Gili BioSensor System)
ContinUse Biometrics Ltd.
Sourced from FDA AI listCardiologyAtrial Fibrillation History Feature
Apple Inc.
Sourced from FDA AI listCardiologySOZO
ImpediMed Limited
Sourced from FDA AI listCardiologyViz HCM
Viz.ai, Inc.
Sourced from FDA AI listCardiologyFFRangio
CathWorks Ltd
Sourced from FDA AI listCardiologyAnalytic for Hemodynamic Instability (AHI)
Fifth Eye Inc.
Sourced from FDA AI listCardiologyVivio® LVEDP System
Avicena, LLC
Sourced from FDA AI listCardiologyECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
Sourced from FDA AI listCardiologyJewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Element Science, Inc.
Sourced from FDA AI listCardiologyAcumen Hypotension Prediction Index (HPI) Feature Software
Edwards Lifesciences LLC
Sourced from FDA AI listCardiologyPersonalized Physiology Analytics Engine software
VGBio, Inc (DBA PhysIQ)
Sourced from FDA AI listCardiologySignalHF (IM008)
Implicity Inc.
Sourced from FDA AI listCardiologyeMurmur Heart AI
Csd Labs
Sourced from FDA AI listCardiologyAssert-IQ (DM5100)
Abbott Medical
Sourced from FDA AI listCardiologyIRNF App
Apple Inc.
Sourced from FDA AI listCardiologyBunkerhill ECG-EF
BunkerHill Health
Sourced from FDA AI list