Caristo Diagnostics has received U.S. Food and Drug Administration (FDA) De Novo authorization for CaRi-Heart, its AI technology that quantifies coronary inflammation from routine coronary CT angiography (CCTA) scans.
CaRi-Heart detects inflammation-related changes in the fat surrounding the coronary arteries, quantifying them as a fat attenuation index score, according to the company. The analysis also generates a CaRi-Heart Risk score, estimating a patient's 10-year cardiovascular mortality risk.
The American Medical Association’s Category III Current Procedural Terminology (CPT) codes 0992T and 0993T are applicable for CaRi-Heart, effective since January 1, 2026, the company noted. Caristo said it plans to begin commercial launch of the technology in the U.S. this quarter, with expansion planned for the fourth quarter of 2026. The company's CaRi-Plaque, which provides quantitative plaque analysis, has also received FDA clearance.
