FDA Clears HeartLungs AI-CVD®, Enabling the Broadest Opportunistic Cardiovascular & Multisystem CT Screening Platform
Summary
HeartLung announced FDA 510(k) clearance for AI-CVD, its AI-powered quantitative imaging platform, establishing an FDA-cleared opportunistic CT screening solution. The platform automatically extracts ten multisystem CT-derived measurements (cardiac, vascular, pulmonary, liver, bone, and body composition) from routine chest and abdominal scans without additional imaging or workflow disruption. HeartLung says AI-CVD can be applied to roughly 40 million U.S. CT scans annually (up to 80 million including head and extremity scans), enabling large-scale early detection and prevention. The clearance integrates previous FDA-cleared modules (AutoChamber, AutoBMD) into a unified system that provides quantitative insights for clinician review rather than diagnostic interpretation.
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