- 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, 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.
Heart disease remains the leading cause of death in the U.S., 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 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 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. 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 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. Find Caristo online on LinkedIn, YouTube, and X.
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