FDA Authorizes CaRi-Heart to Quantify Coronary Inflammation

Caristo Diagnostics announced that the FDA granted De Novo authorization to CaRi-Heart, an artificial intelligence (AI)-based technology that quantifies coronary inflammation from routine coronary computed tomography angiography (CCTA). The company described CaRi-Heart as the first technology authorized in the United States for this purpose.

The technology analyzes inflammation-related changes in the fat surrounding coronary arteries and expresses them as a fat attenuation index score (FAI-Score), Caristo’s proprietary biomarker of coronary inflammation. The analysis also generates the CaRi-Heart Risk score, which estimates a patient’s risk of cardiovascular mortality over 10 years.

Caristo said the tool is intended to add an assessment of coronary inflammation to the information provided by standard CCTA or coronary calcium scoring. According to Caristo, CaRi-Heart has been validated in large independent populations, with findings published in peer-reviewed journals. The technology is also supported by the Oxford Risk Factors and Non-invasive Imaging (ORFAN) study, a coronary CT registry that aims to include long-term outcomes from as many as 250,000 patients worldwide. CaRi-Heart is already available in Europe, Switzerland, the United Kingdom, and Australia.

Caristo plans to begin the US commercial launch of CaRi-Heart during the third quarter of 2026 and expand availability during the fourth quarter. The company also said the American Medical Association assigned Category III Current Procedural Terminology codes 0992T and 0993T, which are applicable to CaRi-Heart and took effect January 1, 2026.

Source: Caristo Diagnostics. Caristo Diagnostics’ CaRi-Heart coronary inflammation technology authorized by US FDA. News release. Caristo Diagnostics; July 29, 2026. Accessed July 31, 2026.