Caristo Diagnostics has announced that the US Food and Drug Administration (FDA) has granted de novo authorisation for its CaRi-Heart technology for the quantification of coronary inflammation from routine coronary CT angiography (CCTA).
CaRi-Heart unmasks previously hidden inflammation and provides clinicians with actionable insights, enabling earlier intervention and personalised treatments for patients, the company says of the technology.
Developed from research conducted at the University of Oxford (Oxford, UK), CaRi-Heart’s flagship technology uses artificial intelligence (AI) to detect inflammation-related changes in the fat surrounding the coronary arteries and quantify them as a fat attenuation index score (FAI-Score). The analysis also generates a CaRi-Heart risk score, a personalised estimate of a patient’s risk of cardiovascular mortality over 10 years.
“We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” said Ron Blankstein (Harvard Medical School and Brigham and Women’s Hospital, Boston USA). “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. It is exciting to see Caristo’s long-awaited, pioneering solution available in the USA.”
Caristo will begin the commercial launch of CaRi-Heart in the USA this quarter and expand during Q4 2026. The American Medical Association has assigned Category III Current Procedural Terminology (CPT) codes 0992T and 0993T, which are applicable for CaRi-Heart, effective since 1 January.
“With CaRi-Heart’s authorisation, we begin a new era of cardiovascular care in the USA, and we thank the FDA for its thoughtful review throughout the de novo authorisation process,” said Steve Deitsch, CEO of Caristo Diagnostics. “This milestone is the result of more than a decade of groundbreaking work by our co-founders at the University of Oxford, clinical research partners, and the entire Caristo team. We have started building our commercial infrastructure to bring this first-of-its-kind technology to US physicians to help prevent the devastating impacts of coronary artery disease.”
CaRi-Heart is Caristo’s flagship technology, part of its growing portfolio of solutions for cardiovascular disease management. The company’s FDA-cleared CaRi-Plaque provides quantitative plaque analysis. CaRi-Heart is also available in Europe, Switzerland, UK, and Australia.
