The US Food and Drug Administration (FDA) has granted De Novo authorization for CaRi-Heart, the first and only technology authorized in the United States to quantify coronary inflammation from routine coronary CT angiography (CCTA). Caristo Diagnostics announced the authorization on July 29, 2026. The technology generates a personalized 10-year cardiovascular mortality risk estimate alongside standard CCTA findings.1
Coronary artery disease remains the world's leading cause of death, and coronary inflammation drives plaque formation and heart attack risk beyond what calcium scoring or CCTA alone can capture. Nearly half of first-time heart attacks occur in patients classified as low-risk by traditional cardiovascular risk assessment. CaRi-Heart addresses this gap by extracting an inflammation signal already present in CT scans clinicians routinely order.1,2
“We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” Ron Blankstein, MD, Harvard Medical School and Brigham and Women’s Hospital, said in a statement. “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.”1
CaRi-Heart applies AI analysis to CCTA images to detect inflammation-related changes in the fat surrounding the coronary arteries. The technology quantifies these changes as the fat attenuation index score, Caristo's proprietary biomarker of coronary inflammation. From this score, the platform generates the CaRi-Heart Risk score, a personalized estimate of a patient's 10-year cardiovascular mortality risk.1
The FDA authorization proceeded through the De Novo pathway, reserved for novel low-to-moderate-risk devices without an existing predicate. Caristo built its regulatory submission on validation data from large independent patient populations, with supporting results published in The Lancet.1
The company also draws on the Oxford Risk Factors and Non-invasive Imaging study, an ongoing coronary CT registry designed to incorporate long-term outcomes data from up to 250,000 patients worldwide. Caristo describes CaRi-Heart as a first-of-its-kind measurement, developed from more than a decade of research originating at the University of Oxford.1
CaRi-Heart clinical impact, CPT coding, and US rollout
The American Medical Association assigned Category III Current Procedural Terminology codes 0992T and 0993T for CaRi-Heart, effective since January 1, 2026, giving practices a coding pathway ahead of commercial rollout. Caristo plans to launch CaRi-Heart commercially in the United States this quarter and expand availability through the fourth quarter of 2026.1
The technology joins CaRi-Plaque, Caristo's FDA-cleared quantitative plaque analysis tool, allowing clinicians to pair inflammation and plaque burden data from a single CCTA acquisition. Together, the two technologies give physicians a fuller cardiovascular risk picture than plaque or calcium data alone can provide.1
“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,” Steve Deitsch, chief executive officer of Caristo, said in a statement. “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.”1
Caristo is building out its US commercial infrastructure to support the CaRi-Heart and CaRi-Plaque portfolio as adoption expands beyond its existing international markets.1
References
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;153(9):e275-e906. doi:10.1161/CIR.0000000000001412
Mueller AS, et al. Limitations of risk- and symptom-based screening in predicting first myocardial infarction. JACC Adv. 2025;4(12 Pt 2):102361. doi:10.1016/j.jacadv.2025.102361
