Reading Inflammation From Perivascular Fat: CaRi-Heart Receives FDA De Novo Authorization

Coronary computed tomography angiography (CCTA) is adept at detecting vascular narrowing and plaque, but may not capture inflammatory risk that is still developing. Caristo Diagnostics’ CaRi-Heart has now received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA), seeking to read subtle changes in tissue surrounding blood vessels from the same images and add another layer of risk information for patients who have not yet developed significant obstruction.

CaRi-Heart uses artificial intelligence to analyze imaging characteristics of fat surrounding the coronary arteries and calculates a Fat Attenuation Index Score (FAI Score) to quantify changes associated with coronary inflammation. The company says the system also combines imaging and clinical information to generate a personalized risk score estimating the likelihood of dying from cardiovascular disease over the next 10 years. The analysis can use CCTA images already obtained in clinical care, with no additional scan required for the software; however, this does not eliminate the radiation and contrast agent required when the patient originally undergoes CCTA.

The authorization was granted through the De Novo pathway under application number DEN250042, meaning the FDA established a classification and regulatory framework for a novel low- to moderate-risk medical device lacking an appropriate existing predicate device. It differs from the 510(k) clearance, K242240, previously obtained for another Caristo product, CaRi-Plaque: the latter focuses on quantitative analysis of coronary plaque, while the former brings inflammation and long-term risk assessment into the same CCTA image. The company plans to begin commercial rollout in the United States in the third quarter of 2026 and expand availability in the fourth quarter.

One of the main bodies of evidence supporting CaRi-Heart comes from the University of Oxford-led ORFAN study. The multicenter longitudinal study, published in *The Lancet* in 2024, included 40,091 patients who underwent CCTA for clinical indications at eight UK hospitals, with a median follow-up of 2.7 years. The study showed that pericoronary inflammation scores were associated with cardiac death and major cardiovascular events and retained predictive information after accounting for traditional risk factors and the extent of coronary artery disease. This supports the tool’s prognostic stratification capabilities, but the study remains primarily based on observational associations and external model validation and cannot directly prove that changing treatment based on the score reduces myocardial infarction or death.

Clinical utility is being further evaluated in the prospective CARE-CCTA study. Trial registry information indicates that the study plans to enroll approximately 15,000 people at multiple community imaging centers in Michigan and compare whether physicians change patient management before and after reviewing CaRi-Heart results, including initiating or adjusting preventive treatment, providing lifestyle recommendations, and referring patients to cardiology. The primary endpoint is the proportion of management decisions that change, rather than cardiovascular events or death. Therefore, even if the results show that physicians adjust management more often, further studies will still be needed to confirm whether those changes produce actual health benefits.

FDA authorization moves coronary inflammation from a research imaging marker into the U.S. healthcare market, but it is not the endpoint for demonstrating clinical benefit. Key questions ahead include performance across different populations and scanning equipment, reliability when image quality is poor, insurance coverage, and how risk scores should be translated into consistent treatment thresholds. Without clear evidence in these areas, adding another risk number could also lead to overtreatment, additional testing, or patient anxiety.