Prevencio’s HART CADhs Test Gains FDA Breakthrough Device Designation

Revolutionizing Heart Health with AI

Prevencio, Inc., based in Kirkland, Washington, has made headlines by securing the FDA Breakthrough Device Designation for its HART CADhs® test. This cutting-edge blood test utilizes artificial intelligence to accurately identify obstructive coronary artery disease (CAD), a significant health issue leading to high morbidity and mortality rates.

Prevencio HART CADhs Test

Receiving this prestigious designation from the U.S. Food and Drug Administration underscores the innovative nature of the HART CADhs test. This breakthrough technology aims to transform how healthcare professionals diagnose CAD, which often goes undetected until serious complications arise. With the support of the FDA, Prevencio is poised to enhance cardiovascular diagnostics significantly.