-- New CPT codes mark a major step toward making Caristo's
CaRi-Heart®--the first AI-powered tool to detect coronary inflammation
from routine CT scans--available in everyday clinical care
-- Rewriting the rules of cardiac risk assessment, Caristo moves beyond
anatomy to reveal the biological drivers of heart disease, helping
doctors predict and prevent life-threatening events before symptoms or
structural changes appear
-- With support from medical societies including the American College of
Cardiology, Caristo achieved CPT approval well ahead of the CaRi-Heart
market launch schedule, accelerating its path from research to
real-world impact
STAMFORD, Conn., April 8, 2025 /PRNewswire/ -- Caristo Diagnostics [https://www.caristo.com/], on a mission to transform the diagnosis and treatment of cardiovascular disease, today announced that the American Medical Association's (AMA) CPT Editorial Panel has approved new Category III CPT® codes for AI-assisted perivascular fat analysis--the foundational capability behind Caristo's flagship CaRi-Heart® technology. The CPT approval marks a critical milestone on CaRi-Heart's path to U.S. clinical adoption and reimbursement, laying the groundwork for broader payer adoption once FDA clearance is achieved. The codes also confirm CaRi-Heart's use on both newly acquired and historical cardiac CT scans, opening the door to proactive, AI-driven risk assessment at scale.
https://mma.prnewswire.com/media/2054669/5255104/Caristo_Logo.jpg [https://mma.prnewswire.com/media/2054669/5255104/Caristo_Logo.jpg]
Heart disease remains the leading cause of death in the U.S. [https://abcnews.go.com/Health/heart-disease-remains-leading-cause-death-us-new/story?id=118136223#:~:text=Heart%20disease%20remains%20the%20leading,for%20which%20data%20is%20available.], yet many heart attacks strike people whose arteries look 'normal' on standard imaging scans. That's because traditional imaging only detects visible plaques that cause narrowings or blockages--it can't see the invisible, biological forces that make heart attacks more likely. Coronary inflammation, a hidden but treatable driver of disease, destabilizes plaque and triggers deadly cardiac events [https://www.nature.com/articles/s41419-024-07166-8] with little or no warning. While statins and anti-inflammatory medications help slow progression, doctors have lacked a precise, widely available way to measure and track coronary inflammation itself. By unlocking this missing piece, Caristo's AI-powered analysis of perivascular fat--now recognized with an AMA-approved CPT code--opens a new frontier in preventive cardiology, enabling doctors to intervene before it's too late.
"This is a huge leap forward in the fight against heart disease, and a major validation that AI-powered coronary inflammation analysis belongs in routine care," said Frank Cheng, CEO of Caristo Diagnostics. "With CPT approval, we are laying the foundation for a future where every at-risk American has access to precision risk assessment, moving heart care from late-stage intervention to truly preventive medicine."
The newly approved CPT codes (X409T and add-on code X434T) will be published on the AMA website by July 2025 and will be effective on January 1, 2026.
A landmark 2024 Lancet study [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00596-8/fulltext] proved that Caristo's CaRi-Heart technology can reveal hidden, high-risk markers of CAD progression -- predicting heart attacks up to a decade before they strike [https://www.prnewswire.com/news-releases/the-lancet-publishes-results-from-worlds-largest-coronary-ct-registry-showing-new-ai-technology-can-predict-cardiac-events-due-to-coronary-inflammation-at-least-10-years-in-advance-302159431.html]. CaRi-Heart uses advanced AI to analyze perivascular fat captured in standard coronary CT angiography (CCTA) scans. The technology reveals hidden coronary inflammation--a powerful but previously invisible predictor of heart attacks. Its proprietary FAI-Score(TM) and CaRi-Heart Risk Score give clinicians and patients a personalized assessment of cardiac mortality risk, informing earlier and more targeted treatment decisions. The CaRi-Heart technology is currently limited to research use in the United States.
Typically less than half of CPT applications are approved, and Caristo's success came well ahead of the CaRi-Heart market launch schedule, a feat made possible by strong support from medical societies such as the American College of Cardiology (ACC) and a growing clinical consensus that coronary inflammation is a modifiable and mission-critical risk factor for heart attack prevention.
In its public comment supporting the CPT application, the ACC wrote:
"The proposed service does more than characterizing tissue as it includes patient [risk] factors and provides a comprehensive risk assessment approach that ensures that the analysis is contextualized within the broader clinical picture, enhancing patient management decisions. The use of this service - the pericoronary fat attenuation index - shows great promise in risk stratification for preventive cardiology."
About Caristo Diagnostics
Caristo Diagnostics is a global leader in AI-powered heart disease detection. A spinout from the University of Oxford, Caristo's award-winning technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear. Backed by leading hospitals and scientists, Caristo is on a mission to save lives through early detection and personalized prevention. For more information, visit caristo.com [https://caristo.com/]. Find Caristo online on LinkedIn [https://www.linkedin.com/company/11841038/admin/], YouTube, [https://www.youtube.com/@caristodiagnostics] and X [https://mobile.twitter.com/CaristoHeart].
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View original content:https://www.prnewswire.co.uk/news-releases/ama-approves-cpt-codes-for-caristos-ai-powered-heart-disease-risk-stratification-and-prevention-technology-302422182.html [https://www.prnewswire.co.uk/news-releases/ama-approves-cpt-codes-for-caristos-ai-powered-heart-disease-risk-stratification-and-prevention-technology-302422182.html]
Photo: https://mma.prnewswire.com/media/2054669/5255104/Caristo_Logo.jpg CARISTO DIAGNOSTICSCONTACT: Frank Cheng | +1(203) 889-5487 info@caristo.com
