FDA Grants Approval for HeartLung’s AI-CVD® to Transform Cardiovascular Screening
HOUSTON, Jan. 16, 2026 — HeartLung Corporation has announced that its AI-CVD®, a cutting-edge AI-driven quantitative imaging platform, has received clearance from the U.S. Food and Drug Administration (FDA) under the regulatory 510(k) process (K252029). This approval significantly enhances preventive healthcare by offering the most extensive opportunistic cardiovascular screening capabilities available within the CT imaging landscape.
The AI-CVD® platform is designed to extract essential cardiovascular and systemic measurements from existing chest and abdominal CT scans, impacting nearly 40 million CT scans conducted annually in the U.S. This innovative tool facilitates the identification of hidden health risks without requiring additional scans, radiation exposure, or disruption to existing workflows.
Key Features of AI-CVD®
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Comprehensive Screening: The platform enables healthcare providers to assess risks related to several conditions, including:
- Coronary heart disease
- Heart failure
- Atrial fibrillation
- Stroke
- Osteoporosis
- Liver steatosis
- Diabetes
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Wide-Ranging Applications: AI-CVD® features ten FDA-cleared measurement domains, including coronary artery calcium (CAC) scoring and lung attenuation analysis, thus allowing for an integrated approach to patient evaluation.
Dr. Morteza Naghavi, Founder and President of HeartLung Corporation, emphasized that this advancement marks a pivotal moment in identifying "silent diseases" such as cardiovascular conditions. By utilizing existing CT scans, AI-CVD® presents a proactive strategy in detecting these conditions long before they escalate into serious health issues.
Experts in the field, including Dr. Arthur Agatston, a pioneer in cardiovascular imaging, support the revolutionary implications of AI-CVD®. By harnessing this technology, clinicians can discover underlying health risks that traditional methods may overlook.
Furthermore, this platform aligns with the ongoing shift in healthcare towards proactive, early detection, and value-based care, tapping into the untapped potential within existing imaging resources.
Now officially cleared for use, AI-CVD® is positioned to redefine preventive healthcare, fostering a comprehensive approach that transcends traditional imaging and healthcare practices.
