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

CALGARY, Alberta, Oct. 29, 2025 (GLOBE NEWSWIRE) -- 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, Director of Adult Congenital Heart Disease at Johns Hopkins. “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 $950 under recent policy updates, alongside higher base payments for the underlying CCTA exam. With cvi42 | Plaque, cardiac imaging sites can retain most 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.

David Wilson
david.wilson@circlecvi.com

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/940e82f4-e7c0-4852-b34f-4dfb569a02c2