Caristo Diagnostics' CaRi-Heart® Receives FDA Approval to Transform Cardiovascular Care

Caristo Diagnostics' CaRi-Heart® Technology Achieves FDA Approval

In a groundbreaking move for cardiovascular healthcare, Caristo Diagnostics has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for their cutting-edge technology, CaRi-Heart®. This revolutionary system is the first of its kind in the United States to measure coronary inflammation via routine coronary CT angiography (CCTA), making it a vital tool for assessing cardiovascular risk and guiding personalized treatment strategies.

Coronary artery disease (CAD) remains the leading cause of mortality worldwide, with coronary inflammation being a significant catalyst in its development. Disturbingly, approximately 50% of first-time heart attack victims fall into the 'low-risk' category according to traditional cardiovascular assessments. By utilizing CaRi-Heart®, clinicians can identify this hidden inflammation and gain actionable insights, leading to timely interventions and enhanced management of cardiovascular health.

Dr. Ron Blankstein from Harvard Medical School emphasized the transformative impact of the CaRi-Heart® technology in the clinical setting, stating that for the first time, practitioners can accurately quantify coronary inflammation, thereby gaining a comprehensive understanding of their patients' cardiovascular risks beyond what standard CCTA or calcium scoring alone can provide.

The commercial launch of CaRi-Heart® is slated to begin in the U.S. this quarter, with plans for expansion in the fourth quarter of 2026. Importantly, the American Medical Association has designated Category III Current Procedural Terminology (CPT®) codes that are applicable for CaRi-Heart®, effective from January 1, 2026, facilitating its integration into clinical practice.

Steve Deitsch, CEO of Caristo Diagnostics, expressed his enthusiasm for this advancement, stating, "With CaRi-Heart's authorization, we are initiating a new era of cardiovascular care in the U.S., and we are grateful to the FDA for their thorough review process." He credits the achievement to over a decade of dedicated research by the company's co-founders at the University of Oxford, alongside collaborative efforts from clinical research partners and the Caristo team. This innovative technology aims to mitigate the serious impacts of coronary artery disease through early detection and proactive healthcare approaches.

CaRi-Heart® represents the flagship offering from Caristo, complementing their other FDA-cleared solution, CaRi-Plaque®, which facilitates quantitative plaque analysis. Together, these technologies empower healthcare providers with a holistic cardiovascular assessment, paving the way for precision medicine and improved patient outcomes.

Developed using advanced AI principles, CaRi-Heart® detects inflammation in the fat surrounding the coronary arteries and evaluates it using a fat attenuation index score (FAI-Score™), which is a proprietary biomarker. Furthermore, it also generates a personalized CaRi-Heart® Risk score that estimates a patient's cardiovascular mortality risk over the span of a decade.

Extensive validation studies have bolstered the credibility of CaRi-Heart®, with findings published in respected peer-reviewed journals, including The Lancet, and supported by the Oxford Risk Factors And Non-invasive imaging study (ORFAN), which is the largest coronary CT registry aiming to include long-term data from up to 250,000 patients globally.

Caristo Diagnostics was formed as a spin-out from the prestigious University of Oxford and has rapidly positioned itself as a leader in AI technologies for cardiovascular disease management. The firm strives to improve healthcare quality by identifying hidden risks of heart disease and providing tools that facilitate early intervention before clinical symptoms arise. As a testament to its innovation and potential, Caristo was recognized as a 2026 Technology Pioneer by the World Economic Forum.

To learn more about Caristo Diagnostics and its pioneering CaRi-Heart® technology, visit Caristo's official website and follow them on social media platforms for updates and insights into cardiovascular innovation.