HeartLung Technologies’ AutoChamber Gains FDA Clearance for Rapid CAD Detection in Chest CT Scans

 A Houston-based AI company has earned FDA 510(k) clearance for AutoChamber, software designed to assess chest CT scans for coronary artery disease (CAD) and other serious heart conditions. AutoChamber quickly analyzes CT images, including those for coronary artery calcium (CAC) and lung cancer screening, delivering a report in 15-20 seconds that estimates cardiac chamber volume and flags irregularities.

AutoChamber is also compatible with coronary CT angiography (CCTA) scans, aiding in the detection of heart failure, atrial fibrillation, and stroke risks—conditions not typically found in standard CT scans. Experts highlight its potential to assess cardiovascular risk for millions who get chest CTs for non-cardiac reasons, allowing for earlier intervention.

Previously awarded the FDA breakthrough device designation, AutoChamber has received prioritized support, underscoring its innovation and potential impact on patient outcomes.

AutoChamber is an AI-powered, cloud-based software developed by HeartLung Technologies, designed to automate the measurement of cardiac chamber volumes and left ventricular wall mass using chest CT scans. This tool enables physicians to detect cardiomegaly in asymptomatic patients, facilitating early intervention to prevent adverse events such as stroke, congestive heart failure (CHF), and atrial fibrillation (AF).

Key Features of AutoChamber:

• Automated Measurements: AutoChamber provides estimates of cardiac volume, individual cardiac chamber volumes, and left ventricular wall mass from both non-contrast and contrast-enhanced chest CT scans.

• Detection Capabilities: The software automatically identifies enlarged heart conditions, including enlarged left atrium (LA), left ventricle (LV), right atrium (RA), right ventricle (RV), and left ventricular hypertrophy (LVH). It also reports the cardiothoracic ratio (CTR).'

• Opportunistic Screening: AutoChamber analyzes existing chest CT scans, allowing for opportunistic detection of life-threatening conditions in asymptomatic patients without the need for additional imaging procedures.

• Rapid Processing: The software processes scans in approximately 5 to 15 seconds, delivering quick results to healthcare providers.

• Integration and Accessibility: AutoChamber functions as a post-processing tool within a Picture Archiving and Communication System (PACS) environment, requiring no additional hardware or capital investment. It is designed for easy implementation without a learning curve or calibration phantom.