HeartLung AI-CVD®

by HeartLung Corporation  · Based in United States → — Advancing AI-enabled, CT-based opportunistic screening and early disease detection.
Cardiology Internal Medicine preventive-medicine

Regulatory Status Disclosed

Overview

HeartLung AI-CVD® is an FDA-cleared, opportunistic AI-powered quantitative imaging tool designed to assist physicians in assessing cardiovascular and multisystem risks. Leveraging existing CT scans, AI-CVD® automatically provides anatomical and density-based measurements that can reveal early indicators of various health conditions.

The tool integrates seamlessly into clinical workflows, analyzing non-gated, non-contrast CT scans (such as those performed for lung cancer screening or other indications) to extract valuable data. This opportunistic screening approach allows for the identification of at-risk patients without requiring additional imaging procedures or radiation exposure, making it a highly efficient and patient-friendly solution.

For physicians, AI-CVD® offers a powerful adjunct to traditional diagnostic methods, providing objective, reproducible measurements that can inform preventative strategies and personalized treatment plans. Its ability to detect subtle changes in cardiovascular structures and tissue densities can lead to earlier interventions and improved patient outcomes across a range of specialties.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated CT-derived measurements
  • Opportunistic screening from existing CT scans
  • Quantitative anatomical analysis
  • Density-based risk assessment
  • FDA-cleared for cardiovascular and multisystem risks
  • Non-gated, non-contrast CT analysis
  • Integration into clinical workflows

Use Cases

  • Early detection of cardiovascular disease
  • Risk stratification for heart disease
  • Identification of patients for preventative interventions
  • Assessment of multisystem health risks from CT scans
  • Population health screening for at-risk individuals
  • Enhancing diagnostic capabilities in radiology and cardiology

What Physicians Need to Know

Cardiac CT/MRI Analysis
HeartLung AI-CVDu00ae is an FDA-cleared, AI-powered platform that extracts opportunistic screening information from cardiac or lung CT scans. It provides automated CT-derived anatomical and density-based measurements for clinician review. The platform analyzes existing chest and abdominal CT scans without additional imaging, radiation, contrast, or workflow disruption. It includes FDA-cleared modules for coronary artery calcium (CAC) scoring, aortic wall calcium, aortic valve calcium, mitral valve calcium, cardiac chamber volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung attenuation analysis, liver attenuation analysis, bone mineral density, and muscle-fat composition. AI-CVDu2122 can measure the size of the aorta and pulmonary artery, which are key indicators of cardiovascular health, helping in early detection of conditions like pulmonary hypertension or aneurysms. It also quantifies liver fat, identifying individuals at risk for cardiometabolic events. The platform can measure thoracic vertebral bone density from CAC scans, which is an important marker for osteoporosis and is independently associated with increased CVD risk. AI-CVDu00ae also includes AutoChamberu2122, an AI-powered tool that detects enlarged cardiac chambers and left ventricular hypertrophy on non-contrast chest CT scans, including low-dose CT used for lung cancer screening and contrast-enhanced coronary CT angiography (CCTA). This AI-based LV volume from CAC scans predicts heart failure over 15 years as accurately as MRI. The platform also offers AutoBMDu2122, an FDA 510(k) cleared, DEXA-equivalent, CT-based opportunistic osteoporosis screening technology.
Arrhythmia Detection Accuracy
AI-enabled Left Atrial Volumetry, a component of AI-CVDu2122, predicts atrial fibrillation earlier and outperforms conventional clinical models. Studies using HeartLung.AI's FDA-cleared AutoChamberu2122 technology within the AI-CVDu00ae platform have shown that routine non-gated, non-contrast chest CT can assess atrial fibrillation risk with performance comparable to dedicated ECG-gated cardiac CT and manually measured echocardiography.
Heart Failure Risk Prediction
AI-CVDu00ae helps physicians predict heart failure, atrial fibrillation, stroke, total CVD, CVD death, and all-cause mortality. AI-driven analysis of cardiac chamber volumes, including the left atrium (LA), left ventricle (LV), right atrium (RA), and right ventricle (RV), provides actionable insights into heart failure and atrial fibrillation risk. Enlarged LA volume strongly predicts AF and stroke, while LV hypertrophy correlates with HF and coronary artery disease. AI-based LV volume from CAC scans predicts heart failure over 15 years as accurately as MRI. This AI CT metric, when added to models with traditional risk factors, significantly improved heart failure risk prediction and outperformed NT-proBNP and CAC score in reclassifying individuals. Myosteatosis, characterized by fat infiltration into skeletal muscle and measured by AI from CAC scans, has shown strong predictive value for heart failure, atrial fibrillation, and coronary heart disease.
Coronary Artery Assessment
AI-CVDu00ae extends beyond coronary artery calcium (CAC) score and coronary artery disease. It includes FDA-cleared modules for coronary artery calcium (CAC) scoring, aortic wall calcium, and aortic valve calcium. HeartLung's coronary calcium solutions include AutoCACu2122, an automated Agatston-1.0 CAC scoring platform, and AI-CACu2122 / Agatston-2.0, an AI-native approach designed to detect and quantify early, subtle, or lower-burden coronary calcium that may be underestimated by conventional scoring. AI-CACu2122 significantly enhances the prediction of cardiovascular events beyond traditional CAC scoring.
AHA/ACC Guideline Alignment
HeartLung strongly supports the 2026 ACC/AHA Multisociety Guideline on the Management of Dyslipidemia, which formally recognizes opportunistic detection of coronary artery calcium (CAC) on routine noncardiac CT scans, including the use of validated artificial intelligence algorithms. HeartLung urges healthcare systems to align with these guidelines by implementing AI-based CAC detection on all eligible CT scans and integrating cardiovascular reporting into routine workflows. The American Heart Association (AHA) has also released a Scientific Statement recognizing AI-enabled opportunistic detection of coronary artery calcium (CAC) on routine chest CT scans as an emerging cornerstone for cardiovascular disease prevention, citing HeartLung Technologiesu2013led studies as seminal evidence.
Physician Tip

Leverage AI-CVDu00ae to transform routine CT scans into comprehensive cardiovascular and multisystem health assessments, identifying hidden risks for heart failure, atrial fibrillation, stroke, and coronary heart disease, as well as osteoporosis, fatty liver disease, and myosteatosis. Utilize the automated measurements of cardiac chambers, calcium scores, and other biomarkers to enhance risk stratification and guide early interventions. The platform's ability to analyze non-gated, non-contrast CT scans makes it a powerful tool for opportunistic screening, maximizing the value of existing imaging data without additional patient burden. Integrate the AI-generated reports into your workflow to streamline patient identification for further diagnostic testing, monitoring, or preventive action.

HeartLung AI-CVDu00ae is a cloud-based platform that requires no new hardware or local software installation. Hospitals and imaging centers can connect their PACS to the HeartLung.AI cloud or manually upload scans. The platform delivers AI-generated DICOM and PDF reports. Your practice can install the HeartLung gateway and receive AutoChamberu2122 AI reports directly in your PACS. The system is designed for rapid AI turnaround, providing results within minutes of sending a scan to the AutoChamberu2122 AI cloud. HeartLung's technologies, including AutoChamberu2122 and AutoBMDu2122, are integrated within the AI-CVDu00ae platform. HeartLung is also expanding beyond CT with upcoming AI-CXR and AI-ECG capabilities. HeartLung has partnered with 3DR Labs to integrate opportunistic AI tools for bone and cardiac health, expanding 3DR's AI Labs ecosystem.

Details

Category Cardiology AI, Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Unknown
Free TrialUnknown
DeploymentCloud-based
Mobile App1
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Preventive Medicine, Pulmonology, Radiology

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Press & Coverage

HeartLung Corporation
FDA Clears HeartLung's AI-CVDu00ae, Enabling the Broadest Opportunistic Cardiovascular & Multisystem CT Screening Platform
HeartLung Corporation announced FDA 510(k) clearance for its AI-CVDu00ae platform, an AI-powered quantitative imaging tool that extracts clinically relevant cardiovascular and systemic measurements from existing chest and abdominal CT scans without additional imaging, radiation, contrast, or workflow disruption.
2026-01
AuntMinnie.com
FDA clears HeartLung's AI-CVD platform
HeartLung has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI-CVD platform, which automates the extraction of cardiovascular and systemic measurements from existing CT scans.
2026-01
EIN Presswire (via FirstWord HealthTech)
HeartLung Technologies Sets New Milestone with Nine Accepted Abstracts at AHA 2025 Showcasing the Power of AI-CVDu2122
HeartLung Technologies announced a record-setting presence at the American Heart Association (AHA) Scientific Sessions 2025, with nine peer-reviewed studies accepted for presentation, highlighting breakthroughs from its AI-CVDu2122 platform.
2025-10
EIN Presswire
HeartLung AI-CVDu00ae Investigator Dr. Reza Mirjalili Wins SCCT 2026 Rapid-Fire Award for AI-CVDu00ae Heart Failure Prediction
Dr. Seyed Reza Mirjalili won the SCCT 2026 Rapid-Fire Award for his presentation on the AI-CVD-HF heart failure prediction model, which leverages coronary artery calcium (CAC) scans.
2026-01
EIN Presswire
Study Shows AI-CVDu00ae Outperforms Diabetes in Predicting Heart Failure Risk
HeartLung Corporation announced the publication of a new study in the American Journal of Preventive Cardiology, demonstrating that AI-CVDu00ae outperforms diabetes in predicting heart failure risk.
2026-05
EIN Presswire
HeartLung.AI Marks Unprecedented Scientific Milestone with 10 Presentations at ESC Congress 2026
HeartLung.AI announced it will present ten abstracts at the ESC Congress 2026, highlighting AI advances in cardiovascular imaging, risk prediction, and preventive care from routine CT scans.
2026-08
HeartLung.AI
AI-enabled left atrial volumetry in coronary artery calcium scans (AI-CAC) predicts atrial fibrillation as early as one year, improves CHARGE-AF, and outperforms NT-proBNP: - HeartLung.AI
A study published in the Journal of Cardiovascular Computed Tomography in April 2024 concluded that AI-CAC LA volume predicted atrial fibrillation as early as one year and significantly improved risk classification compared to CHARGE-AF Risk Score and NT-proBNP.
2024-04
ReachMD
FDA-Cleared AI Medical Device Tracker
HeartLung's AI-CVD analyzes chest CT scans to automatically detect and quantify cardiovascular disease markers, including coronary artery calcium, a strong predictor of future cardiac events, by extracting information from existing CTs.
2026-05

Videos

Product demos, reviews, and walkthroughs for HeartLung AI-CVD®.

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Frequently Asked Questions

HeartLung AI-CVDu00ae is an FDA-cleared, AI-powered quantitative imaging platform that analyzes existing CT scans to provide automated measurements for various cardiovascular and systemic conditions. It helps cardiologists by enabling early detection, risk stratification, and preventive intervention for conditions like coronary heart disease, heart failure, atrial fibrillation, and stroke, utilizing scans already performed for other indications.
HeartLung AI-CVDu00ae offers a comprehensive suite of measurements including coronary artery calcium (CAC) scoring, aortic and mitral valve calcium, cardiac chamber volumetry, epicardial fat volumetry, and aorta and pulmonary artery sizing. These measurements extend beyond traditional CAC scoring to predict risks for heart failure, atrial fibrillation, and stroke.
Yes, HeartLung AI-CVDu00ae is FDA-cleared (510(k) K252029) and designed for opportunistic screening, meaning it extracts valuable data from CT scans already being performed without requiring additional imaging, radiation, contrast, or workflow disruption. It integrates by converting routine imaging into a multi-disease prevention platform.
While traditional methods like dedicated ECG-gated cardiac CT and echocardiography are used for cardiac assessment, HeartLung AI-CVDu00ae differentiates itself by opportunistically extracting information from *existing* non-cardiac CT scans. It aims to provide a broader, more cost-effective, and less burdensome approach to early detection compared to some contrast-enhanced CT angiography (CCTA) AI solutions that focus primarily on plaque analysis.
HeartLung AI-CVDu00ae is an opportunistic screening tool and does not provide diagnostic interpretation or risk prediction on its own; rather, it provides measurements for clinician review. It is not intended to replace dedicated diagnostic workups like echocardiography or cardiac MRI, which remain essential for dynamic assessments of ejection fraction, valves, and hemodynamics.
Millions of CT scans are performed annually, yet many critical cardiovascular and cardiometabolic findings often go unmeasured or unreported. HeartLung AI-CVDu00ae helps close this gap by automatically extracting quantitative imaging biomarkers from these routine CT scans and converting them into physician-facing reports to support earlier detection and intervention.
While specific pricing details are not publicly available in the provided search results, HeartLung.AI emphasizes that its AI-CVDu00ae platform aims to provide greater clinical value from existing scans without additional cost or radiation to the patient. Some imaging centers offer AI-enhanced CT screening packages that include AI-CVDu00ae analysis for a single price.

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Suggest an Edit → | Report an issue | Last Verified: 2026-09-17 | First Added: 2026-09-17
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