HeartLung Technologies has achieved a significant milestone with its AutoChamber AI, securing both FDA Breakthrough Device designation and marketing authorization. This marks the first opportunistic AI designed to aid in the detection of heart disease using existing CT scans, potentially impacting millions of patients. The AI is designed to analyze standard thoracic CT scans, including lung scans and coronary artery calcium (CAC) scoring, to identify risks associated with heart failure, atrial fibrillation, and stroke – conditions that often go unreported in routine assessments.
Opportunistic Detection of Asymptomatic Heart Disease
AutoChamber AI leverages deep learning algorithms to analyze chest CT scans, which are frequently performed for various diagnostic purposes such as lung cancer screening and CAC scoring. By integrating AutoChamber AI into CAC scans, HeartLung aims to introduce AI-CAC and AI-CVD, advancing preventive cardiology by analyzing both coronary artery plaque calcification and cardiac chamber volumes.
According to Dr. Morteza Naghavi, founder and president of HeartLung Technologies, this technology can opportunistically screen millions of CT scans done for other reasons and help doctors detect high-risk patients for cardiovascular disease (CVD) and sudden cardiac death (SCD). This makes AutoChamber a cost-effective solution for physicians and the healthcare system.
Clinical Validation and Performance
HeartLung 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 demonstrated that AutoChamber AI outperformed traditional epidemiological risk scores and predicted heart failure, atrial fibrillation, and stroke comparably to cardiac MRI and contrast-enhanced CT scans.
Dr. David Yankelevitz, professor of radiology at Icahn School of Medicine at Mount Sinai Hospital, highlighted the potential of this technology, stating, "This is a real breakthrough that can help save many lives from unexpected stroke and heart failure. We plan to add this AI to our lung cancer screening population who are high risk for cardiovascular events."
Integration and Reporting
The AI processes scans in approximately 15-20 seconds, generating a quantitative imaging report with percentiles and cutoff points to guide physician decision-making. The report is designed to be patient-friendly, featuring color-coded percentiles and snapshots of heart chambers for easy visualization and understanding.
Dr. Anthony Reeves, professor of electrical engineering and computer vision at Cornell University, noted, "There is a lot of useful information in a heart or lung CT scan that is not currently reported because radiologists are unable to visualize or quantitatively evaluate them. AI-enabled algorithms like AutoChamber can fill this gap without imposing extra work on radiologists."
Future Implications
The FDA Breakthrough Device designation is reserved for medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. This designation expedites the development, assessment, and review process, ensuring timely access to innovative technologies for patients and healthcare providers.
HeartLung Technologies also received FDA clearance for AutoBMD, an AI-powered opportunistic bone density measurement test that works on any CT scan of the chest and abdomen to help doctors quickly identify patients who are having accelerated bone loss and are at risk of cracks, compressions or fractures in their bones which can be deadly in the elderly population.
HeartLung Technologies aims to expand its AI solutions for early detection of preventable deaths from heart disease, lung cancer, osteoporosis, and fatty liver disease. The company's focus is on leveraging existing CT scans to identify and address these conditions in their early stages.
