FDA Grants De Novo Authorization for AI-Based Coronary Inflammation Quantification from CCTA Exams

The Food and Drug Administration (FDA) has granted a De Novo classification for the AI-enabled CaRi-Heart software, which enables quantification of coronary inflammation that may signal elevated cardiovascular risks, even in patients with low or zero coronary artery calcium (CAC) scoring.¹

Caristo Diagnostics, the developer of CaRi-Heart, said the software detects inflammation-related changes in the fat surrounding the coronary arteries with subsequent quantification via a fat attenuation index score (FAI score). The proprietary biomarker of coronary inflammation, derived from coronary computed tomography angiography (CCTA) scans, provides individualized cardiovascular mortality risk over a 10-year period, according to the company.

In a recent study presented at the Society of Cardiovascular Computed Tomography (SCCT) conference and involving over 19,000 patients and a 6.7-year median follow-up period, researchers found striking results with the FAI score in patients with CAC scores < 10.² Those in the top decile (>90th centile) of FAI scores had an approximately 13-fold higher cardiovascular (CV) mortality risk compared to those below the 25th centile, while those in the top decile of FAI score derived from non-contrast CT had an approximately eightfold higher risk, according to the research.

In a recent interview with Diagnostic Imaging, lead study author Kenneth Chan, MBBS, discussed the ability of the CaRi-Heart software’s FAI score to improve risk stratification in patients with low or zero CAC scores, and the potential of garnering this data from non-contrast CTs.³

“It's potentially applicable in the screening setting for primary prevention, because the non-contrast scan is usually lower cost with no needles and no contrast, which is better for the patient. If they're already getting the calcium score, we can also extract information to complement the risk assessment, really enhancing the power of cardiac CT for screening of cardiovascular risk,” noted Dr. Chan, a Clinical Research Fellow in Cardiology within the Division of Cardiovascular Medicine at the University of Oxford in Oxford, England.

In a statement about the FDA De Novo authorization for the CaRi-Heart software, Ron Blankstein, MD, emphasized the importance of timely assessment of coronary inflammation.

“We’ve spent decades building the scientific case that coronary inflammation is an important contributor to the development and progression of coronary plaque,” said Dr. Blankstein, the director of cardiac CT and associate director of the cardiovascular imaging program at Brigham and Women’s Hospital in Boston. “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 Diagnostics noted that the Category III Current Procedural Terminology (CPT) codes 0992T and 0993T are applicable for use of the CaRi-Heart software.

References

1. Caristo Diagnostics. Caristo Diagnostics’ CaRi-Heart® coronary inflammation technology authorized by U.S. FDA. PR Newswire. Available at: https://www.prnewswire.com/news-releases/caristo-diagnostics-cari-heart-coronary-inflammation-technology-authorized-by-us-fda-302837657.html . Published July 29, 2026. Accessed July 29, 2026.

2. Chan K, Gissier MC, Sobirov I, et al. Quantifying coronary inflammation on contrast or non-contrast cardiac CT enhances CV risk stratification beyond coronary calcium score and plaque volume. Presented at the Society of Cardiovascular Computed Tomography (SCCT) conference, July 9-12, 2026, San Diego. Available at: https://cattendee.abstractsonline.com/meeting/21508/meeting-info .

3. Hall J. Study: AI measurement of coronary inflammation from CT scans can identify high CV risk patients with low or zero CAC scores. Available at: https://www.diagnosticimaging.com/view/study-ai-measurement-coronary-inflammation-ct-scans-identify-high-cv-risk-patients-with-low-or-zero-cac-scores . Published July 25, 2026. Accessed July 29, 2026.