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.

Cardiology

Caption AI

GE HealthCare (Caption Health)

CEFDAHCTGA

Real-time deep-learning guidance that coaches any clinician through the 10 standard transthoracic echocardiographic views — providing over 90 types of probe-movement instructions and a live Quality Meter — enabling nurses and non-sonographers to acquire diagnostic-quality cardiac ultrasound studies without prior echocardiography training.

Cardiology

HeartFlow FFRCT Analysis

HeartFlow, Inc.

CEFDAUKCA

Patient-specific 3-D computational fluid dynamics model of the coronary circulation, derived from standard coronary CT angiography (CCTA) DICOM data, that yields a colour-coded fractional flow reserve (FFRCT) map across the coronary tree — enabling non-invasive, lesion-level physiological assessment of haemodynamically significant stenosis without adenosine stress or invasive catheterisation.

Cardiology

KardiaAI

AliveCor, Inc.

FDATGA

Deep-neural-network software platform that interprets short ECG recordings from AliveCor's Kardia family of personal and point-of-care electrocardiogram devices. From a 30-second single- or six-lead trace, KardiaAI returns an instant rhythm determination — atrial fibrillation, normal sinus rhythm, bradycardia, tachycardia and, since the 2020 second-generation clearance, sinus rhythm with premature ventricular contractions, with supraventricular ectopy, or with wide QRS. Determinations are advisory: positive or unclassified results route to a clinician, and the algorithm makes no treatment decision.

Cardiology

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Anumana, Inc.

FDA

Software-as-a-medical-device deep-learning algorithm that analyses standard 12-lead electrocardiogram voltage-time data to detect signals associated with pulmonary hypertension, notifying clinicians of patients who may warrant further diagnostic evaluation. Cleared by the FDA in March 2026 under a new pulmonary-hypertension-specific product code (SAT), it is the first algorithm cleared for PH detection from a standard 12-lead ECG — a deliberately low-barrier input, since 12-lead ECGs are already acquired routinely across primary care, cardiology and emergency settings.

Cardiology

Zio (ZEUS System)

iRhythm Technologies, Inc.

CEFDAPMDA

Deep-learned ECG analysis system (ZEUS) behind the Zio family of wear-and-return ambulatory cardiac monitors. A single-lead patch records up to 14 days of continuous ECG; the ZEUS deep neural network classifies the full recording into rhythm classes, and certified cardiographic technicians curate the algorithm output into a clinician-facing report. The underlying network was shown in Nature Medicine (2019) to match or exceed averaged cardiologist performance on 12 rhythm classes. FDA-cleared across five 510(k)s since 2018, CE-marked under the EU MDR, and approved in Japan.

Cardiology

Us2.ai

Eko.ai Pte. Ltd. (Us2.ai)

CEFDAHCPMDATGA

Software that reads a standard transthoracic echocardiogram and returns a full structured report — chamber volumes, ejection fraction, global longitudinal strain and diastolic-function measurements — without a sonographer or cardiologist tracing the images by hand. The whole study is analysed automatically from the DICOM loops, with no manual selection of which view is which, positioning the tool as a workflow accelerant for the measurement-and-reporting step of an echo rather than a diagnostic verdict.

Cardiology

Hypertension Notification Feature (HTNF)

Apple Inc.

CEFDAHCTGA

Over-the-counter software feature on Apple Watch that scores optical pulse (photoplethysmography) signals collected in the background with a machine-learning model and, when the scores across a 30-day period form a pattern suggestive of hypertension, notifies the wearer to confirm with a blood-pressure cuff and a clinician. It never reports a blood pressure. Its cleared use is adults aged 22 and over with no prior hypertension diagnosis, not during pregnancy, and the labelling states that the absence of a notification does not mean the absence of hypertension.

Cardiology

FFRangio System

CathWorks (a Medtronic company)

CEFDAPMDA

Software that computes fractional flow reserve for the entire coronary tree from the routine angiogram already acquired in the catheterisation lab — no pressure wire, no hyperaemic drug, no additional imaging. From angiographic projections the system reconstructs a 3D model of the coronary arteries and derives FFRangio values from simulated blood-flow information, giving the interventional cardiologist lesion-level physiology while the patient is still on the table.

Cardiology

Eko Murmur Analysis Software (EMAS)

Eko Health (Eko Devices)

FDA

Cloud-based machine-learning software that analyses heart sounds — and ECG signals when available — recorded with Eko electronic stethoscopes. EMAS detects whether a murmur is present and characterises it, identifying S1 and S2, murmur timing, and whether a murmur is innocent or structural. It is decision support for the examining clinician, cleared for adult and paediatric patients; its output is not a sole means of diagnosis.

Cardiology

Cardiologs

Philips (Cardiologs Technologies)

CEFDA

Cloud-based software that reads ambulatory electrocardiograms with a deep neural network. Cardiologs ingests recordings from Holter monitors, patches, event recorders and other single- or multi-lead devices, detects and labels heartbeats, measures rhythm and produces a draft report for a clinician to review and sign. It is a decision-support tool, not an autonomous diagnostician: the interpreting professional edits and validates every report.

Cardiology

PCWP Analysis Software

Cardiosense, Inc.

FDA

Prescription software that noninvasively estimates pulmonary capillary wedge pressure (PCWP) and identifies whether a patient's PCWP is above or below 18 mmHg, for patients diagnosed with heart failure with reduced ejection fraction (HFrEF) and NYHA class II, III or IV symptoms. It reads seismocardiogram, electrocardiogram and photoplethysmogram signals captured by the company's CardioTag chest-worn sensor and returns the estimate to a qualified healthcare professional, who uses it alongside other standard of care parameters, the patient's history, symptoms and other diagnostic tests. The granting order states that patient management decisions should not be made solely on its results.

Cardiology

Cardio AI (Tempus Pixel Cardio)

Arterys (Tempus AI)

CEFDAHC

Cloud-native cardiac MRI post-processing that automates ventricular segmentation and function quantification — biventricular volumes, ejection fraction, mass and, in later versions, flow and tissue-characterisation maps. The deep-learning contours are editable: the software proposes measurements that the reading clinician reviews and corrects, so it is decision-support rather than an autonomous reader. Now marketed under Tempus as Tempus Pixel Cardio, with Arterys Inc. remaining the FDA applicant of record.

Cardiology

Cleerly Coronary Analysis

Cleerly, Inc.

CEFDAUKCA

Analysis of coronary CT angiograms that segments and quantifies atherosclerotic plaque — total volume, per-vessel burden and composition (calcified, non-calcified, low-attenuation) — grades stenosis, and, in the ISCHEMIA module, predicts the vessel-level functional significance of a lesion. The FDA has cleared two distinct products under this line: Cleerly Labs (plaque and stenosis quantification) and Cleerly ISCHEMIA (a machine-learned ischaemia estimate). Four US 510(k) clearances; no CE mark or other international authorisation was verifiable in this review.

Cardiology

EchoGo Heart Failure

Ultromics

CEFDAUKCA

Cloud-based echocardiography AI that auto-calculates ejection fraction and detects heart-failure with preserved ejection fraction (HFpEF) from a single apical four-chamber view.

Cardiology

EchoNext

Pathwai, Inc.

Editorial summaryCardiology

Global Hypoperfusion Index (GHI) Algorithm

Edwards Lifesciences, LLC

Sourced from FDA AI listCardiology

Acumen Hypotension Prediction Index (HPI) Feature Software

Edwards Lifesciences LLC

Sourced from FDA AI listCardiology

Rooti Rx ECG Event Recorder, Rooti Link APP Software

Rooti Labs Ltd.

Sourced from FDA AI listCardiology

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

Samsung Electronics Co., Ltd

Sourced from FDA AI listCardiology

InVision Precision Cardiac Amyloid

InVision Medical Technology Corporation

Sourced from FDA AI listCardiology

IRNF App

Apple Inc.

Sourced from FDA AI listCardiology

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati

Element Science, Inc.

Sourced from FDA AI listCardiology

SignalHF (IM008)

Implicity Inc.

Sourced from FDA AI listCardiology

FFRct

HEARTFLOW, INC.

Sourced from FDA AI listCardiology

Steth IO

STRATOSCIENTIFIC, INC.

Sourced from FDA AI listCardiology

CLEWICU System

Clew Medical Ltd.

Sourced from FDA AI listCardiology

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

Verily Life Sciences LLC

Sourced from FDA AI listCardiology

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

Edwards Lifeciences, LLC

Sourced from FDA AI listCardiology

CorVista System with PH Add-On

Analytics for Life, Inc.

Sourced from FDA AI listCardiology

prolaio eVO2peak Module (Version 1.0)

Prolaio, Inc.

Sourced from FDA AI listCardiology

Gili Pro BioSensor (also known as “Gili BioSensor System”)

ContinUse Biometrics Ltd.

Sourced from FDA AI listCardiology

CardioVision

Icardio.Ai

Sourced from FDA AI listCardiology

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

Anumana, Inc.

Sourced from FDA AI listCardiology

SOZO

ImpediMed Limited

Sourced from FDA AI listCardiology

EchoGo Amyloidosis (1.0)

Ultromics Limited

Sourced from FDA AI listCardiology

Tempus ECG-AF

Tempus AI, Inc.

Sourced from FDA AI listCardiology

APPRAISE-HRI

The Surgeon General, Department of the Army (TSG-DA)

Sourced from FDA AI listCardiology

eCARTv5 Clinical Deterioration Suite (“eCART”)

AgileMD, Inc.

Sourced from FDA AI listCardiology

Loss of Pulse Detection

Fitbit

Sourced from FDA AI listCardiology

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

Empatica S.R.L.

Sourced from FDA AI listCardiology

Irregular Rhythm Notification Feature (IRNF)

Apple Inc.

Sourced from FDA AI listCardiology

FEops HEARTguide

FEops NV

Sourced from FDA AI listCardiology

Cleerly ISCHEMIA

Cleerly, Inc

Sourced from FDA AI listCardiology

Eko Analysis Software

Eko Devices Inc

Sourced from FDA AI listCardiology

AHI System

Fifth Eye Inc.

Sourced from FDA AI listCardiology

DEEPVESSEL FFR

KeyaMed NA Inc.

Sourced from FDA AI listCardiology

CorVista® System

CorVista Health, Inc.

Sourced from FDA AI listCardiology

Saranas Early Bird Bleed Monitoring System

Saranas Inc.

Sourced from FDA AI list

Other specialties