July 29, 2026 — Caristo Diagnostics has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for CaRi-Heart, the first and only technology authorized in the U.S. to quantify coronary inflammation from routine coronary CT angiography (CCTA). Coronary artery disease (CAD) is the world's leading cause of death.1 Coronary inflammation is a key driver of CAD and plaque formation, and increases the risk of heart attack. "We've spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque," said Ron Blankstein, M.D., Harvard Medical School and Brigham and Women's Hospital. "And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard CCTA, or calcium scoring alone. The analysis also generates the CaRi-Heart Risk score, a personalized estimate of a patient's risk of cardiovascular mortality over 10 years.