The artificial intelligence platform analyzes routine coronary CT angiography to estimate patients’ 10-year cardiovascular risk.
The US Food and Drug Administration (FDA) granted De Novo authorization to Caristo Diagnostics for its CaRi-Heart technology, which quantifies coronary inflammation from routine coronary CT angiography, according to a company press release.
Coronary artery disease is the leading cause of death globally, and coronary inflammation is a primary driver of the disease and plaque formation. Nearly 50% of first-time heart attacks occur in patients classified as low-risk under traditional cardiovascular risk assessment methods, the company says in a release. The technology is designed to identify hidden inflammation to provide clinicians with insights for earlier intervention and personalized treatment.
“We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” says Ron Blankstein, MD, Harvard Medical School and Brigham and Women’s Hospital, in a release. “And now for the first time, clinicians can specifically measure coronary inflammation, obtaining a more complete picture of cardiovascular risk compared to standard coronary CT angiography, or calcium scoring alone.”
Caristo Diagnostics will begin the commercial launch of the technology in the US this quarter and expand during the fourth quarter of 2026. The American Medical Association has assigned Category III Current Procedural Terminology codes 0992T and 0993T for the technology, which became effective Jan 1, 2026.
“With CaRi-Heart’s authorization, we begin a new era of cardiovascular care in the US, and we thank the FDA for its thoughtful review throughout the De Novo authorization process,” says Steve Deitsch, CEO of Caristo Diagnostics, in a release. He notes that the milestone is the result of more than a decade of “groundbreaking” work by the company’s co-founders at the University of Oxford, clinical research partners, and the entire Caristo team.
The technology uses artificial intelligence to detect inflammation-related changes in the fat surrounding the coronary arteries. It quantifies these changes as a fat attenuation index score, which serves as a biomarker of coronary inflammation. The analysis also generates a risk score that provides a personalized estimate of a patient’s risk of cardiovascular mortality over 10 years.
The platform is part of a portfolio that includes the company’s previously cleared technology, CaRi-Plaque, for quantitative plaque analysis. Using both technologies, clinicians receive a “comprehensive” cardiovascular risk assessment to improve patient outcomes, according to the press release.
The technology has been validated in large independent populations and is supported by the Oxford Risk Factors And Non-invasive imaging study. This coronary CT registry aims to include long-term outcomes data from up to 250,000 patients worldwide. The technology is also available in Europe, Switzerland, Australia, and the United Kingdom.
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