FDA Clears HeartLung's AI-CVD Platform for Comprehensive Opportunistic Screening Across Multiple Disease Domains
核心洞察
HeartLung Corporation (搜索) received FDA 510(k) clearance for AI-CVD (搜索), the most comprehensive opportunistic screening platform for CT imaging, enabling automated detection of cardiovascular and systemic disease risks from routine scans.
The platform integrates ten FDA-cleared measurement modules including coronary artery calcium (搜索) scoring, cardiac chamber (搜索) volumetry, and bone mineral density analysis, applicable to nearly 40 million CT scans performed annually in the United States.
AI-CVD (搜索) transforms routine diagnostic imaging into a multi-disease prevention platform by extracting clinically relevant measurements from existing chest and abdominal CT scans without requiring additional radiation or workflow disruption.
HeartLung Corporation (搜索) announced U.S. Food and Drug Administration (FDA) clearance of AI-CVD (搜索)®, its flagship AI-powered quantitative imaging platform, under 510(k) K252029, marking what the company describes as a major inflection point in preventive medicine and opportunistic screening. The clearance positions AI-CVD® as the most comprehensive FDA-cleared opportunistic screening platform available for CT imaging.
The platform enables automated extraction of clinically relevant cardiovascular and systemic measurements from existing chest and abdominal CT scans without requiring additional imaging, radiation, contrast, or workflow disruption. FDA-cleared AI-CVD (搜索)® can be applied to nearly 40 million CT scans performed annually in the United States, representing approximately half of all CT scans, and up to 80 million scans when including head and extremity imaging.
Comprehensive Multi-Domain Screening Capabilities
AI-CVD (搜索)® is an opportunistic, AI-powered quantitative imaging tool that provides automated CT-derived anatomical and density-based measurements for clinician review. Using these quantitative imaging measurements and clinical evaluation, healthcare providers can investigate patients who are unaware of their risk of coronary heart disease (搜索), heart failure (搜索), atrial fibrillation (搜索), stroke (搜索), osteoporosis (搜索), liver steatosis (搜索), diabetes (搜索), and other adverse health conditions that may warrant follow-up.
The platform includes FDA-cleared modules for ten measurement domains: coronary artery calcium (搜索) (CAC) scoring, aortic wall calcium, aortic valve calcium, mitral valve calcium, cardiac chamber (搜索) volumetry, epicardial fat (搜索) volumetry, aorta and pulmonary artery sizing, lung attenuation analysis, liver attenuation analysis, and bone mineral density and muscle-fat composition. All volumetric measurements are adjusted for body surface area and reported in absolute values and population-based percentiles, referenced to the Multi-Ethnic Study of Atherosclerosis (搜索) (MESA) and Framingham Heart Study (FHS).
Clinical Expert Perspectives
"For decades, medicine has waited for patients to declare disease. AI-CVD (搜索)® allows us to find disease while it is still silent—using scans that already exist," said Dr. Morteza Naghavi, Founder and President of HeartLung Corporation (搜索). "This FDA clearance represents a fundamental shift: CT is no longer just diagnostic imaging—it becomes a scalable, opportunistic prevention platform capable of identifying risk across the heart, lungs, bones, liver, and metabolism in a single pass."
The platform builds on established cardiovascular imaging foundations, as noted by Scientific Advisory Board members. "Coronary calcium revealed long ago that atherosclerosis (搜索) begins well before symptoms," said Arthur Agatston, MD, Clinical Professor of Medicine at Florida International University and developer of the Agatston Coronary Calcium Score. "AI-CVD (搜索)® extends that insight by enabling systematic identification of patients who are unaware of their cardiovascular risk—using CT scans that already exist."
David Yankelevitz, MD, Professor of Radiology at Icahn School of Medicine at Mount Sinai and Co-Principal Investigator of IELCAP, emphasized the value extraction potential: "Modern CT contains far more clinically meaningful information than we traditionally extract. AI-CVD (搜索)® allows clinicians to leverage routine CT scans responsibly and efficiently, without adding imaging burden. That is exactly how opportunistic screening should be done and we are now entering the new domain of comprehensive screening."
Addressing Systemic Disease Detection
The platform reflects growing recognition that cardiovascular disease (搜索) rarely exists in isolation. "By integrating quantitative measurements across the heart, vasculature, lungs, liver, bone, and body composition, AI-CVD (搜索)® provides a scientifically grounded framework to identify individuals who may benefit from closer evaluation across multiple disease domains," said Zahi Fayad, PhD, Professor of Radiology and Medicine and Director of the BioMedical Engineering and Imaging Institute at Icahn School of Medicine at Mount Sinai.
Robert Kloner, MD, PhD, Director of the Cardiovascular Research Institute at Huntington Medical Research Institutes and Professor of Medicine at the Keck School of Medicine of USC, highlighted the clinical impact: "Many of the most serious cardiovascular and metabolic conditions progress silently for years. This AI allows identification of structural abnormalities that the human eye may otherwise miss, hence helping to bring hidden risk into clinical focus, enabling informed decisions about further evaluation and prevention."
Evolution of Preventive Care
Nathan D. Wong, PhD, MPH, FACC, FAHA, FNLA, MASPC, Professor of Medicine and Director of the Heart Disease Prevention Program at University of California, Irvine, noted the limitations of current prevention strategies: "Primary prevention has long depended on risk factors and probability scores, yet we continue to see cardiovascular events in patients who were never identified as high risk. Quantitative CT findings—such as markedly elevated coronary calcium and enlargement of cardiac chambers, particularly the left atrium and ventricle—directly reveal underlying disease burden. AI-CVD (搜索)® provides a scalable, FDA-cleared pathway to incorporate these objective phenotypes into preventive care, representing a necessary evolution of modern prevention."
Opportunistic Implementation Strategy
Unlike traditional screening programs that require dedicated exams, referrals, and reimbursement pathways, AI-CVD (搜索)® operates as an opportunistic add-on to CT scans already being performed for other clinical indications, including lung cancer screening CT, coronary calcium scans, diagnostic chest CT, coronary CT angiography (CCTA), CT pulmonary angiography (CTPA), and abdominal and pelvic CT.
Regulatory Significance
With this clearance, HeartLung now holds FDA authorization across ten opportunistic screening indications within a single AI platform, positioning AI-CVD (搜索)® as a foundational technology for population-scale preventive imaging. The company has previously received FDA Breakthrough Device Designation and FDA 510(k) clearance for AutoChamber (搜索)™ and AutoBMD (搜索)™, which are now integrated within the AI-CVD® platform.
The platform is designed to transform routine diagnostic imaging into what the company describes as a powerful, scalable engine for early detection and prevention, addressing what it characterizes as one of healthcare's most persistent failures—missed opportunities to detect silent disease before irreversible events occur.