What You Should KnowOxford spin-out Caristo Diagnostics has secured FDA De Novo authorization for CaRi-Heart®, making it the first and only technology authorized in the U.S. to quantify coronary inflammation from routine Coronary CT Angiography (CCTA). Pericoronary Fat Attenuation and CPT Billing ArchitectureSpun out of the University of Oxford, Caristo’s AI platform quantifies pericoronary fat attenuation directly from routine CCTA scans, offering U.S. clinicians a non-invasive method to measure active coronary inflammation. Combines the FAI-Score™ with anatomical plaque metrics and patient demographics to produce the CaRi-Heart® Risk Score—a personalized 10-year estimate of cardiovascular mortality. “We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” stated Ron Blankstein, M.D., of 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.”