FDA clears new AI-enabled coronary plaque analysis software
Circle Cardiovascular Imaging (Circle CVI), a Canadian medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its new artificial intelligence (AI)-powered platform for coronary CT angiography (CCTA) evaluations.
cvi42 | Plaque uses the company’s advanced AI algorithms to assess a patient’s CCTA results and provide a comprehensive analysis of any coronary plaques. This helps care teams deliver personalized treatment plans that minimize risk and get the patient the exact care they need.
“With the new cvi42 | Plaque, I now have immediate and interactive control over my anatomic coronary CCTA imaging analysis,” James Thompson, DO, director of adult congenital heart disease at Johns Hopkins Medicine, said in a statement. “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 clearance of cvi42 | Plaque marks a significant advancement for cardiology departments and imaging centers,” added 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.”
AI-enabled coronary plaque assessments have gained significant momentum thanks to the success of companies such as Heartflow, Cleerly and Elucid. In fact, the American Medical Association recently issued a brand new Category I CPT code for the use of technologies that quantify coronary plaque buildup in imaging results and identify signs of coronary artery disease. The new code, known as 75XX6 until it receives a full number, goes into effect in January 2026.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.