FDA Grants De Novo Authorization to Caristo's CaRi-Heart, First AI-Powered Coronary Inflammation Quantification Technology
核心洞察
The FDA has granted De Novo authorization to Caristo Diagnostics (搜索)' CaRi-Heart (搜索), the first U.S.-authorized technology to quantify coronary inflammation from routine CCTA scans.
CaRi-Heart (搜索) uses advanced AI to detect inflammation-related changes in perivascular fat, generating a proprietary FAI-Score and a personalized 10-year cardiac mortality risk estimate.
Research shows nearly 50% of first-time heart attacks occur in people classified as "low-risk," and patients without obstructive CAD account for two-thirds of MACE and cardiac deaths.
Caristo Diagnostics (搜索) announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for CaRi-Heart (搜索), making it the first and only technology authorized in the United States to quantify coronary inflammation from routine coronary CT angiography (CCTA). The authorization marks a significant milestone in cardiovascular risk assessment, addressing a long-standing blind spot in traditional diagnostic approaches.
Coronary artery disease (搜索) (CAD) remains the world's leading cause of death. Coronary inflammation is a key driver of CAD and plaque formation, increasing the risk of heart attack. Critically, nearly 50% of first-time heart attacks occur in people classified as "low-risk" with traditional cardiovascular risk assessment. CaRi-Heart (搜索) aims to unmask this previously hidden inflammation, providing clinicians with actionable insights that enable earlier intervention and personalized treatment strategies.
"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., of 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."
How CaRi-Heart (搜索) Works
Developed from research at the University of Oxford, CaRi-Heart (搜索) employs advanced artificial intelligence to detect inflammation-related changes in the fat surrounding the coronary arteries. These changes are quantified 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.
The technology has been validated in large independent populations and published in leading peer-reviewed journals, including The Lancet. CaRi-Heart (搜索) is supported by the Oxford Risk Factors And Non-invasive imaging study (ORFAN), the world's largest coronary CT registry, which aims to include long-term outcomes data from up to 250,000 patients worldwide.
Clinical Evidence and Unmet Need
Traditional CCTA images the heart and coronary arteries to detect narrowed or blocked vessels. Patients diagnosed with obstructive CAD undergo treatment to clear blockages. However, people with clear arteries can still suffer heart attacks and other major adverse cardiac events (MACE). Traditional tools have been unable to identify high-risk patients without obstructive CAD.
A U.K. study of Caristo's technology, which enrolled more than 40,000 people undergoing CCTA at eight U.K. hospitals and tracked them for a median of 2.7 years, found that patients without obstructive CAD accounted for two-thirds of MACE and total cardiac deaths. The Caristo tool successfully differentiated patients at very high risk of cardiac mortality and MACE from those at low or medium risk by combining a score based on inflammation-induced radiological changes, plaque burden, and the patient's risk factors to assign individuals to one of three risk categories.
Commercial Launch and Reimbursement
Caristo will begin the commercial launch of CaRi-Heart (搜索) 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 and have been effective since January 1, 2026.
"With CaRi-Heart (搜索)'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 (搜索). "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."
Deitsch, who joined Caristo as CEO in April, brings experience gained as CFO of OrganOx, which was acquired by Terumo for $1.5 billion during his tenure. The company has been building out its commercial infrastructure in preparation for the U.S. launch.
A Growing Portfolio
CaRi-Heart (搜索) 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. CaRi-Heart is also available in Europe, Switzerland, the United Kingdom, and Australia.