FDA Grants De Novo Authorization for Coronary Inflammation Quantification Technology

July 29, 2026 — Caristo Diagnostics has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for CaRi-Heart, the first and only technology authorized in the U.S. to quantify coronary inflammation from routine coronary CT angiography (CCTA).

Coronary artery disease (CAD) is the world's leading cause of death.¹ Coronary inflammation is a key driver of CAD and plaque formation, and increases the risk of heart attack. Nearly 50% of first-time heart attacks occur in people classified as "low-risk" with traditional cardiovascular risk assessment.² CaRi-Heart unmasks previously hidden inflammation and provides clinicians with actionable insights, enabling earlier intervention and personalized treatments for patients.

"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, M.D., Harvard Medical School and Brigham and Women's Hospital. "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 U.S."

Caristo will begin the commercial launch of CaRi-Heart in the U.S. 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 Jan. 1, 2026.

FDA Authorization

"With CaRi-Heart's authorization, we begin a new era of cardiovascular care in the U.S., and we thank the FDA for its thoughtful review throughout the De Novo authorization 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 U.S. physicians to help prevent the devastating impacts of CAD."

CaRi-Heart is Caristo's flagship technology, part of a growing portfolio of solutions for cardiovascular disease management. The company's FDA-cleared CaRi-Plaque provides quantitative plaque analysis. With both technologies, clinicians receive a comprehensive cardiovascular risk assessment, enabling more accurate care and improved health outcomes for patients.

Developed from research at the University of Oxford, CaRi-Heart's flagship technology uses 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 generates the CaRi-Heart Risk score, a personalized estimate of a patient's risk of cardiovascular mortality over 10 years. CaRi-Heart has been validated in large independent populations and published in leading 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 worldwide. CaRi-Heart is also available in Europe, Switzerland, the United Kingdom, and Australia.

1. Palaniappan LP, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Committee. 2026 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2026 Mar 3;153(9):e275-e906. doi: 10.1161/CIR.0000000000001412. Epub 2026 Jan 21. PMID: 41562125.
2. Mueller AS, et al. Limitations of Risk- and Symptom-Based Screening in Predicting First Myocardial Infarction. JACC Adv. 2025 Dec;4(12 Pt 2):102361. doi: 10.1016/j.jacadv.2025.102361. Epub 2025 Nov 18. PMID: 41260145; PMCID: PMC12666810.