Prevencio Receives FDA Breakthrough Device Designation for HART CADhs, Its Artificial Intelligence-driven Blood Test for Obstructive Coronary Artery Disease
KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular diagnostics, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its HART CADhs® test. This designation recognizes HART CADhs as an innovative technology for identifying obstructive coronary artery disease (CAD)—a condition responsible for significant morbidity and mortality. The designation is reserved for technologies that offer significant advantages over existing solutions and address unmet medical needs.
HART CADhs is the only AI-based multi-protein blood test capable of accurately detecting blockage in the heart’s arteries. By combining multiple cardiac proteins with proprietary machine learning algorithms, HART CADhs delivers actionable insight through a simple, non-invasive blood draw, bridging critical diagnostic gaps in current cardiovascular care.
