HeartLung Technologies' AutoChamber AI Receives FDA Breakthrough Device Designation for Cardiac Chamber Volumetry

HeartLung Technologies (search)Search term has announced that its AI-enabled Automated Cardiac Chambers Volumetry (AutoChamber (search)Search drug) has received Breakthrough Device designation and marketing authorization from the U.S. Food and Drug Administration (FDA). This AI tool is designed for early detection of heart disease (search)Search disease and other conditions through analysis of cardiac chamber volumes.

How AutoChamber AI Works

AutoChamber (search)Search drug AI reports the volume of cardiac chambers and left ventricular wall mass using non-contrast computed tomography (CT) scans, including heart scans for coronary artery calcium (CAC) score and lung scans for lung cancer (search)Search disease screening. It also functions with coronary CT angiography (CCTA) scans. The AI takes approximately 15-20 seconds to process and flag patients, generating a quantitative imaging report with percentiles and cutoff points to guide physician action.

Clinical Significance

According to Dr. Morteza Naghavi, founder and president of HeartLung Technologies (search)Search term, AutoChamber (search)Search drug AI can evaluate the risk of heart failure (search)Search disease, atrial fibrillation (search)Search disease, and stroke (search)Search disease by adding its analysis to thoracic CT scans. Dr. David Yankelevitz, professor of radiology at Icahn School of Medicine at Mount Sinai Hospital, noted the potential for adding this AI to lung cancer (search)Search disease screening programs, as these patients are at high risk for cardiovascular events. The AI creates a quantitative imaging report with appropriate percentiles and cutoff points that help physicians to take necessary actions.

Supporting Data and Studies

HeartLung Technologies (search)Search term presented several studies to the FDA comparing AI-enabled CT measurements with cardiac MRI, contrast-enhanced cardiac CT, NT-proBNP, CHARGE-AF Risk Score, ASCVD Pooled Cohort Equation, and PREVENT Risk Scores. These studies indicated that AutoChamber (search)Search drug AI outperformed traditional epidemiological risk scores and predicted heart failure (search)Search disease, atrial fibrillation (search)Search disease, and stroke (search)Search disease comparably to cardiac MRI and contrast-enhanced CT scans.

Impact on Healthcare

The "Breakthrough" value of AutoChamber (search)Search drug AI lies in its ability to screen millions of CT scans done for other reasons, helping doctors detect high-risk patients for cardiovascular disease (CVD) and sudden cardiac death (SCD). Dr. Nathan Wong, a professor of medicine and epidemiology at University of California, Irvine, emphasized the potential for identifying individuals at increased risk who could benefit from earlier intervention. Dr. Anthony Reeves, professor of electrical engineering and computer vision at Cornell University, noted that AI-enabled algorithms like AutoChamber can fill the gap in radiologists' ability to efficiently visualize and quantitatively evaluate relevant diagnostic image features without imposing extra work.

Future Directions

HeartLung Technologies (search)Search term is also developing AI-CAC (search)Search drug and AI-CVD (search)Search drug, which combine coronary artery plaque calcification and cardiac chambers volume analysis to advance preventive cardiology. The company's broader goal is to build autonomous AI for early detection of heart disease (search)Search disease, lung cancer (search)Search disease, osteoporosis (search)Search disease, and fatty liver disease (search)Search disease.