FDA Clears Circle CVI’s On-Premise AI Tool for Coronary Plaque Analysis

Circle Cardiovascular Imaging Inc. (Circle CVI) has received FDA 510(k) clearance for its latest innovation, cvi42 | Plaque—an AI-powered, on-premise software solution designed to streamline and enhance coronary plaque analysis directly within clinical environments. With this clearance, the tool becomes available for use across the United States, offering a new level of autonomy and precision for cardiac imaging teams.

Unlike cloud-based platforms that require external processing, cvi42 | Plaque enables clinicians to perform detailed coronary computed tomography angiography (CCTA) analysis entirely in-house. The system identifies and quantifies total plaque burden, including calcified and non-calcified deposits, offering reproducible results that support early detection and improved risk assessment for coronary artery disease.

“The clearance of cvi42 | Plaque marks a significant advancement for cardiology departments and imaging centers,” said 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 tool's AI algorithms are designed to deliver high-speed, high-accuracy results, aiding in more personalized care strategies. Dr. James Thompson, DO, a specialist in Adult Congenital Heart Disease at Johns Hopkins All Children’s Hospital, highlighted its clinical value: “With the new cvi42 | Plaque, I now have immediate and interactive control over my anatomic coronary CCTA imaging analysis. 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.”

The launch comes amid changing reimbursement policies that now favor on-site AI-based plaque analysis. A Category III CPT code (0625T) with a $950 national Medicare payment has already been established, allowing imaging centers to bill directly for AI-assisted plaque quantification. More notably, a permanent Category I CPT code (75XX6) will take effect in January 2026. This transition reflects broader clinical acceptance and paves the way for standard physician reimbursement, solidifying plaque analysis as part of routine cardiovascular care.

By enabling cardiac imaging providers to maintain control over both workflow and billing, cvi42 | Plaque minimizes reliance on third-party services, potentially maximizing both efficiency and revenue. The system is also vendor-agnostic and integrates smoothly with existing CT platforms, making it adaptable to a wide variety of imaging environments.

This FDA clearance marks another step in Circle CVI’s mission to provide flexible, forward-thinking solutions that align with evolving clinical needs. With cvi42 | Plaque, cardiovascular teams are equipped with a tool that not only enhances diagnostic precision but also aligns with the latest reimbursement and care delivery models in cardiac imaging.