Caristo Diagnostics, a specialist in AI technologies for cardiovascular disease, has received De Novo authorisation from the US Food and Drug Administration (FDA) for CaRi-Heart, the first technology authorised in the US to quantify coronary inflammation from routine coronary CT angiography (CCTA)
Coronary artery disease (CAD) is the world’s leading cause of death, with coronary inflammation acting as a key driver of CAD and plaque formation, and increasing the risk of heart attack. Almost 50% of first-time heart attacks occur in people classified as ‘low-risk’ with traditional cardiovascular risk assessment. CaRi Heart reveals previously hidden inflammation and provides actionable insights to enable earlier intervention and personalised treatments for patients.
Ron Blankstein, Harvard Medical School and Brigham and Women’s Hospital, said, “We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque. 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 US.”
Caristo will begin the commercial launch of CaRi-Heart in the US this quarter, with plans to expand in 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 January 1, 2026.
Steve Deitsch, CEO of Caristo Diagnostics, said, “With CaRi-Heart’s authorisation, we begin a new era of cardiovascular care in the US, and we thank the FDA for its thoughtful review throughout the De Novo authorisation process. 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 CAD.”
CaRi-Heart is Caristo’s flagship technology, part of a portfolio of solutions for cardiovascular disease management. Caristo’s FDA-cleared CaRi-Plaque provides quantitative plaque analysis. Clinicians can receive a comprehensive cardiovascular risk assessment by using both technologies, enabling more accurate care and improved health outcomes.
Developed from research at the University of Oxford, CaRi-Heart’s technology utilises advanced AI to detect inflammation-related changes in the fat surrounding the coronary arteries and quantify them as a fat attenuation index score (FAI-Score), Caristo’s validated proprietary biomarker of coronary inflammation. The analysis also produces the CaRi-Heart Risk score, an estimate of a patient’s risk of cardiovascular mortality over 10 years.
CaRi-Heart has been validated in independent populations and published in peer-reviewed journals, including The Lancet. CaRi-Heart is supported by the Oxford Risk Factors and Non-invasive Imaging Study (ORFAN), the world’s largest coronary CT registry that aims to include long-term outcomes data from up to 250,000 patients globally. CaRi-Heart is also available in Europe, Switzerland, the UK, and Australia.
