FDA gives AI-powered blood test for obstructive CAD breakthrough device designation
Kirkland-based Prevencio has earned FDA breakthrough device designation for its HART CADhs test, an AI-powered, multi-protein blood test for detecting obstructive coronary artery disease.
HART CADhs is a multi-protein test that includes advanced AI algorithms capable of detecting signs of obstructive coronary artery disease (CAD) in heart patients. The test received its designation as part of the FDA’s breakthrough devices program, which fast-tracks promising medical technologies that could significantly improve patient care and outcomes.
Prevencio’s achievement underscores Washington state’s leadership in AI-driven diagnostics and cardiovascular innovation.