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Circle CVI Announces FDA Clearance for cvi42 | Plaque for Coronary Artery Disease Evaluation

October 29, 2025

CALGARY, CANADA, OCTOBER 29, 2025 – Circle Cardiovascular Imaging Inc. (Circle CVI), a global leader in cardiovascular imaging solutions, today announced that its cvi42 | Plaque solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is now available for clinical use in the United States. This innovative, AI-enabled solution allows clinicians to perform comprehensive coronary plaque analysis directly on-premise, enhancing diagnostic workflows and patient care.


“The clearance of cvi42 | Plaque marks a significant advancement for cardiology departments and imaging centers,” stated Erkan Akyuz, CEO of Circle CVI. “As a secure, on-premise solution, it allows for the evaluation of coronary artery disease without the need to send patient data to an external reading service. This provides clinicians with greater control over their data, improved study processing times, and enhanced workflow efficiency.”


The AI-enabled technology within cvi42 | Plaque delivers fast, accurate, and reproducible results for quantifying total, calcified, and non-calcified plaque. This detailed analysis supports more precise risk stratification and helps inform personalized treatment plans.


“With the new cvi42 | Plaque, I now have immediate and interactive control over my anatomic coronary CCTA imaging analysis,” said Dr. James Thompson, DO, Adult Congenital Heart Disease at Johns Hopkins All Childrens. “Circle CVI truly comes full circle — continuing to invest, innovate, and impress by advancing imaging applications and enhancing our cardiac CTA workflow.



This is foundational to CCTA’s front-line role in cardiovascular disease prevention, driving early translational impact and transformative patient care. Empowering early detection of the high-risk plaque attack.”


Medicare now covers AI-enabled coronary plaque analysis from CCTA with a Category III CPT code, 0625T, and national payment set at $950under recent policy updates, alongside higher base payments for the underlying CCTA exam.With cvi42 | Plaque, cardiac imaging sites can retainmost of the reimbursement, rather than outsourcing analysis and reimbursement to external providers.


AI-enabled coronary plaque analysis has been assigned a permanent Category I CPT code, 75XX6, which takes effect in January 2026. This new code, replacing previous Category III codes,facilitates national pricing and enables physician reimbursement; the AMA’s update signifies that plaque quantification is now recognized as standard clinical care in cardiovascular medicine.


cvi42 | Plaque integrates seamlessly into existing CT workflows and is compatible with all major vendor systems, providing a complete solution for cardiac imaging teams. The FDA clearance reinforces Circle CVI's commitment to delivering innovative, reliable, and user-friendly solutions that empower clinicians to provide the best possible care for their patients.


Discover how Circle CVI’s cvi42|Plaque can elevate your practice. Visit https://www.circlecvi.com/get-started to learn more and book a demo today.

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January 20, 2026
Coverage unlocks reimbursable AI plaque quantification, advancing coronary risk assessment in everyday cardiology practice. Highlights New permanent Category I CPT code 75577 for AI-enabled coronary plaque analysis took effect January 1, 2026 Major payers, including Aetna, alongside UnitedHealthcare, Cigna, Humana, and others, now cover AI-enabled coronary plaque analysis, extending access to tens of millions of commercially insured patients Circle’s FDA-cleared, on-premise cvi 42 |Plaque solution integrates directly into CCTA workflows, giving physicians hands-on control of AI plaque analysis and retains more of the plaque analysis reimbursement Calgary, Alberta – Circle Cardiovascular Imaging Inc. (Circle CVI), the market leader in cardiovascular imaging postprocessing, announced that clinical practices using its FDA 510(k)-cleared cvi 42 with AI-enabled plaque analysis solution are well positioned to benefit from newly activated reimbursement for AI-enabled coronary plaque analysis under permanent Category I CPT code 75577, effective January 1, 2026. Major insurance companies have also announced that they are also reimbursing the costs of this analysis. New Category I CPT Codes Now in Effect Beginning January 1, 2026, AIdriven quantification and characterization of coronary atherosclerotic plaque derived from coronary CT angiography (CCTA) is reimbursed under a permanent Category I CPT code, 75577, replacing prior Category III codes. This transition enables nationally valued payment for quantitative plaque assessment across hospital outpatient departments, imaging centers, and physician offices. Growing Payer Support for AI Plaque Analysis Major commercial payers, including Aetna, UnitedHealthcare, Cigna, Humana, and others, now cover AI-based quantitative coronary plaque analysis , extending access to tens of millions of commercially insured patients and building on prior Medicare coverage decisions. This expanding reimbursement is expected to accelerate adoption of CCTA-based plaque assessment. AMA/ACC Guidance on When to Use Plaque Analysis In December 2025, a major scientific statement published in the Journal of the American College of Cardiology : Cardiovascular Imaging provided consensus recommendations on how and when to use quantitative coronary plaque analysis (QCPA) in practice. Their recommendations stated that among patients who have visual evidence of plaque on coronary CTA, adding QCPA may be useful for enhancing risk assessment and guiding the initiation or intensification of preventive therapies. CCTA’s Emerging Role as a Primary CAD Modality Recent analyses from cardiovascular imaging experts highlight how CCTA, augmented by AI-enabled plaque analysis, is poised to become the foundational imaging modality for the diagnosis and management of coronary artery disease. As reimbursement stabilizes and technology matures, CCTA is increasingly viewed as the frontline test that can characterize both stenosis and atherosclerotic burden, informing preventive strategies long before invasive procedures are required. cvi42|Plaque: FDA-cleared, On-premise AI for Coronary Plaque cvi 42 |Plaque, cleared by the U.S. FDA in late 2025, is an on-premise, AI-enabled coronary plaque analysis module that integrates directly into existing cvi 42 and CCTA workflows. The software automatically segments the coronary lumen and vessel wall, quantifies plaque burden and composition, and generates structured lesion- and vessel-level metrics to support risk stratification, preventive therapy decisions, and revascularization planning. Because the solution runs locally, image data, AI processing, and reporting remain within the institution’s environment, giving physicians interactive control over contouring and final interpretation while allowing programs to retain a larger share of reimbursement compared with outsourced, cloud only services. Localized AI and Circle’s Elevate Pricing Advantage “With the new Category I CPT code for coronary plaque analysis now in effect, and the major insurance players reimbursing plaque analysis, the economics and clinical evidence are finally aligned,” said Chris Bazinet, Chief Commercial Officer at Circle CVI. “cvi 42 |Plaque gives practices an on-premise, FDA-cleared AI solution that fits directly into their existing CCTA workflows, enabling guideline consistent plaque reporting, improved risk stratification, and better capture of the reimbursement now available for quantitative coronary plaque analysis.” cvi 42 |Plaque is available as part of the broader cvi 42 platform for cardiac CT and MR. Clinical sites interested in implementing AI-enabled coronary plaque analysis can contact Circle to assess readiness, workflow integration, and revenue potential. - ENDS - About Circle Cardiovascular Imaging Circle Cardiovascular Imaging Inc. (Circle CVI) is a Canadian-based company founded in 2007 with a mission to develop innovative software solutions that enhance cardiovascular and cerebrovascular imaging analysis and ultimately improve patient care. Circle’s flagship platform, cvi 42 , delivers best-in-class image reading and reporting tools for quantitative and qualitative assessment of cardiac MR, cardiac CT, vascular CT, and neuro CT. At the core of Circle’s work is a relentless commitment to empowering healthcare providers with advanced, intuitive tools that lead to better healthcare outcomes. This passion for innovation, rooted in both medicine and technology, drives Circle’s global impact and fuels a culture of excellence. Today, millions of medical imaging exams each year—across 1,700+ hospitals in over 90 countries—are interpreted using Circle’s cvi 42 platform.​ For media inquiries, please contact: marketing@circlecvi.com