AI-CVD

by HeartLung Corporation  · Based in United States → — Advancing AI-enabled, CT-based opportunistic screening and early disease detection.
Cardiology Pulmonology Radiology
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Regulatory Status Disclosed

Overview

AI-CVD® by HeartLung Corporation is an FDA-cleared, AI-powered quantitative imaging platform designed for opportunistic screening of cardiovascular and multisystem diseases. It automatically extracts clinically relevant anatomical and density-based measurements from existing chest and abdominal CT scans, without requiring additional imaging, radiation, contrast, or workflow disruption.

The platform transforms routine diagnostic imaging into a powerful, scalable engine for early detection and prevention, enabling healthcare providers to identify hidden risks for conditions such as coronary heart disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, and diabetes.

AI-CVD® integrates multiple FDA-cleared technologies, including AutoChamber™ for detecting enlarged cardiac chambers and AutoBMD™ for opportunistic bone mineral density measurement, offering a comprehensive approach to population-scale preventive imaging.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated CT-derived anatomical and density-based measurements
  • Opportunistic screening from existing chest and abdominal CT scans
  • No additional imaging, radiation, contrast, or workflow disruption
  • Coronary Artery Calcium (CAC) scoring
  • Aortic wall, aortic valve, and mitral valve calcium analysis
  • Cardiac chamber volumetry (Left Atrium, Left Ventricle, Right Atrium, Right Ventricle)
  • Epicardial fat volumetry
  • Aorta and pulmonary artery sizing
  • Lung attenuation analysis
  • Liver attenuation analysis (for fatty liver disease)
  • Bone mineral density and muscle-fat composition (myosteatosis)
  • Integration of AutoChamberu2122 and AutoBMDu2122 technologies
  • Generates a comprehensive 'cardiovascular digital twin'

Use Cases

  • Early detection and prevention of cardiovascular disease
  • Opportunistic screening for lung cancer and emphysema/COPD
  • Identification of osteoporosis risk from routine CT scans
  • Detection of fatty liver disease and cardiometabolic abnormalities
  • Risk stratification for heart failure, atrial fibrillation, and stroke
  • Population-scale preventive imaging and value-based care initiatives

What Physicians Need to Know

Cardiac CT/MRI Analysis
AI-CVD is an FDA-cleared AI platform that extracts opportunistic screening information from cardiac or lung CT scans. It performs automated CT-derived anatomical and density-based measurements. Key modules include coronary artery calcium (CAC) scoring, aortic wall, aortic valve, and mitral valve calcium assessment, cardiac chamber volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung attenuation analysis, liver attenuation analysis, and bone mineral density and muscle-fat composition.
Arrhythmia Detection Accuracy
The tool provides insights into atrial fibrillation (AFib) risk through AI-driven analysis of cardiac chamber volumes from CT scans.
Heart Failure Risk Prediction
AI-CVD significantly enhances cardiovascular disease (CVD) risk stratification, including the prediction of heart failure, atrial fibrillation, stroke, total CVD, CVD death, and all-cause mortality. Its AI-driven analysis of cardiac chamber volumes offers actionable insights into heart failure risk. The AI-CVD-HF model, utilizing AI-derived features from CAC scans, demonstrated superior heart failure prediction with a 10-year AUC of 0.83 compared to PREVENT-HF.
Coronary Artery Assessment
AI-CVD extends beyond traditional coronary artery calcium (CAC) scoring and coronary artery disease assessment. It includes FDA-cleared modules for CAC scoring, as well as the evaluation of aortic wall calcium, aortic valve calcium, and mitral valve calcium, identifying hidden heart risks for early intervention.
AHA/ACC Guideline Alignment
AI-CVD is an FDA-cleared platform, indicating clinical validation. Its capability for opportunistic screening and early identification of cardiovascular risks, including coronary heart disease, heart failure, atrial fibrillation, and stroke, aligns with preventive care strategies emphasized by major cardiology guidelines.
Physician Tip

AI-CVD offers a powerful, opportunistic screening approach by leveraging existing cardiac or lung CT scans to uncover hidden cardiovascular and systemic risks without additional imaging or radiation. Physicians can utilize its comprehensive quantitative measurements and risk stratification capabilities to identify patients at risk for conditions like heart failure, atrial fibrillation, and coronary artery disease, enabling earlier intervention and personalized prevention strategies. The platform's ability to analyze various anatomical and density-based measurements, including cardiac chamber volumes and calcifications, provides a more holistic view of patient health.

AI-CVD functions as an AI-powered quantitative imaging platform, designed to integrate with existing CT scan workflows. It processes echocardiograms in real time, automatically generating complete reports with minimal user intervention. It extracts and quantifies cardiovascular and other systemic measurements from routine chest and abdominal CT scans, enhancing CVD risk stratification by integrating imaging disease measures.

Details

Category Cardiology AI
Pricing Contact for pricing
DeploymentCloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

AI-CVD® received U.S. Food and Drug Administration (FDA) 510(k) clearance (K252029) on January 12, 2026. It is cleared as an AI-powered quantitative imaging platform for opportunistic cardiovascular and multisystem CT screening, encompassing ten FDA-cleared opportunistic measurement domains.
Integrations
EHR Not specified
Specialties Cardiology, Pulmonology, Radiology

What the Web Says

AI-CVD, developed by HeartLung.AI, is an AI-powered tool designed to predict cardiovascular disease risk using chest X-rays. Reviews highlight its potential to improve early detection and risk stratification, particularly in primary care settings, by leveraging existing imaging data.

Overall: Positive

Strengths

  • Utilizes readily available chest X-rays, avoiding new imaging costs.
  • Potential for early detection of cardiovascular disease.
  • Aids in risk stratification for better patient management.
  • Integrates into existing clinical workflows.
  • Non-invasive and accessible screening method.
  • May reduce healthcare disparities by increasing access to screening.

Limitations

  • Relatively new technology, long-term efficacy and impact still being studied.
  • Requires validation across diverse populations and healthcare systems.
  • Potential for over-diagnosis or false positives, leading to unnecessary follow-ups.
  • Integration challenges with various Electronic Health Record (EHR) systems.
  • Physician reliance on AI tools may lead to reduced critical thinking.
  • Data privacy and security concerns with AI processing patient images.

Based on reviews from: HeartLung.AI website, Healthcare IT news articles, Medical journal pre-prints and studies, Physician forums and discussions, Tech review sites (general AI in healthcare)

Last updated: 2026-07-18

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Press & Coverage

PRWeb
FDA Clears HeartLung's AI-CVDu00ae, Enabling the Broadest Opportunistic Cardiovascular & Multisystem CT Screening Platform
HeartLung Corporation announced FDA clearance of AI-CVDu00ae, an AI-powered quantitative imaging platform that transforms routine CT scans into a comprehensive multi-disease prevention platform for cardiovascular and systemic measurements. This clearance positions AI-CVDu00ae as the most comprehensive FDA-cleared opportunistic screening platform for CT imaging, addressing missed opportunities to detect silent diseases.
2026-01
AuntMinnie
FDA clears HeartLung's AI-CVD platform
HeartLung received 510(k) clearance from the FDA for its AI-CVD platform, which automates the extraction of cardiovascular and systemic measurements from existing chest and abdominal CT scans without additional procedures. The company states that AI-CVD can be applied to nearly 40 million CT scans annually in the U.S., aiding in the assessment of risks for various diseases like coronary heart disease and stroke.
2026-01
EIN Presswire
Study Shows AI-CVDu00ae Outperforms Diabetes in Predicting Heart Failure Risk
HeartLung Corporation published a study in the American Journal of Preventive Cardiology demonstrating that its AI-CVD AutoChamber module can identify left atrial enlargement, left ventricular enlargement, and increased left ventricular mass from routine coronary artery calcium scans. These AI-derived findings are independently associated with incident heart failure, even outperforming diabetes in predicting risk.
2026-05
Signify Research
Multi-Condition Clearances, Regulation Updates and Funding - Signify Research
HeartLung received FDA clearance for AI-CVD, an opportunistic screening platform that extracts cardiovascular, metabolic, and skeletal risk insights from routine CT scans. This article also discusses broader US-FDA regulatory updates, including proposals for streamlined pathways for radiology AI and clarifications on LLM-based tools.
2026-02
BMJ Open Diabetes Research & Care
AI-enabled opportunistic measurement of liver steatosis in coronary artery calcium scans predicts cardiovascular events and all-cause mortality: an AI-CVD study within the Multi-Ethnic Study of Atherosclerosis (MESA)
This study investigates a new AI-CVD algorithm for opportunistic measurement of liver steatosis from CAC scans, finding that a higher liver attenuation index is associated with increased incidence of cardiovascular disease, stroke, and all-cause mortality over 15 years. The AI-CVD suite of software modules enables opportunistic screening for multiple disorders in chest CT scans.
2025-04
The National Law Review
HeartLung Announces USPTO Issuance of Foundational AI-CVD Patent and Allowance for Vasa Vasorum Inflammation Imaging
HeartLung Corporation announced the issuance of U.S. Patent No. 12,620,494, titled u201cPredicting adverse health risk based on CT scan images and AIu2013enabled cardiovascular structure volumetry,u201d strengthening its intellectual property in AI-enabled preventive imaging. This patent protects core innovations behind using routine CT scans to uncover hidden heart disease.
2026-05
Circulation: Cardiovascular Imaging (American Heart Association)
AI-Derived LA Volume Index, LA/RA and LA/LV Volume Ratios From Coronary Artery Calcium Scans Predict Long-Term Atrial Fibrillation and Stroke
This study, part of the AI-CVD initiative, evaluated the predictive value of AI-derived left atrial volume index and related chamber ratios from routine CAC scans for incident atrial fibrillation and stroke. The findings suggest that these AI-derived metrics significantly improve reclassification beyond established risk scores.
2026-04
EIN News
Two HeartLung.AI Studies Show Routine Chest CT Assesses Cardiac Risk Like Dedicated Cardiac CT and Echocardiography
HeartLung.AI announced the acceptance of two studies demonstrating that AI can extract clinically meaningful cardiac chamber measurements from routine non-gated, non-contrast chest CT scans. These studies, utilizing the FDA-cleared AutoChamberu2122 technology within the AI-CVDu00ae platform, show comparable performance to dedicated cardiac CT and echocardiography in assessing heart failure and atrial fibrillation risk.
2026-07

Videos

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

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Frequently Asked Questions

AI-CVD tools can be integrated by analyzing existing imaging data, such as echocardiograms or CT scans, or electronic health record (EHR) data to provide risk stratification, assist in diagnosis, or predict outcomes. These tools often function as decision support systems, flagging potential issues or insights for physician review rather than replacing clinical judgment.
AI-CVD solutions, especially those for diagnosis or treatment recommendations, require regulatory clearance as medical devices (e.g., FDA in the US, CE Mark in Europe). Physicians must verify the product's regulatory status and ensure it adheres to data privacy regulations like HIPAA, as these systems often process sensitive patient data.
Traditional methods like the Framingham Risk Score, ASCVD Risk Estimator, and comprehensive physician-led clinical judgment based on patient history, physical exams, and standard diagnostic tests are primary alternatives. These might be preferred when AI data input is insufficient, or for patients with atypical presentations not well-represented in AI training data.
Pricing models for AI-CVD platforms often include subscription fees, per-study charges, or tiered licensing based on practice size or usage volume. ROI can be demonstrated through improved diagnostic accuracy, earlier intervention, reduced readmissions, optimized resource allocation, and potentially better patient outcomes, though direct reimbursement for AI use is still evolving.
Key limitations include potential biases in training data leading to reduced accuracy in diverse populations, the 'black box' nature of some algorithms making interpretability difficult, and the critical need for high-quality, standardized data input. AI also lacks the ability to fully integrate a patient's clinical factors like history and lifestyle, and over-reliance could risk 'deskilling' physicians.
Physicians should expect robust clinical validation studies demonstrating the AI-CVD tool's accuracy, sensitivity, and specificity in relevant patient populations, ideally published in peer-reviewed journals. Evidence should also address generalizability across diverse cohorts and demonstrate a clear clinical benefit or improved workflow efficiency in prospective studies.

Compare AI-CVD

VS
AI-CVD vs PMcardio
Cardiology AI Adjacent · 65/100
Both AI-powered tools focus on cardiology, but they utilize different diagnostic modalities. AI-CVD leverages existing CT scans for opportunistic screening of cardiovascular and multisystem diseases, while PMcardio interprets…
VS
AI-CVD vs EchoNext
Cardiology AI Adjacent · 65/100
AI-CVD and EchoNext are adjacent competitors, both focused on early detection of cardiovascular disease but utilizing different diagnostic modalities. AI-CVD leverages existing CT scans for opportunistic screening, providing…
VS
AI-CVD vs KardiaPro
Cardiology AI Adjacent · 60/100
AI-CVD focuses on opportunistic screening for cardiovascular and multisystem diseases using existing CT scans to detect hidden health risks. KardiaPro, on the other hand, is a remote patient…
VS
AI-CVD vs Tyto Stethoscope
Cardiology AI Adjacent · 65/100
AI-CVD is an AI-powered quantitative imaging platform that screens for cardiovascular and multisystem diseases using existing CT scans, focusing on early detection of hidden risks through automated measurements.…

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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