Circle CVI positions cvi42 for TAVR volume surge after CMS ruling
Circle Cardiovascular Imaging (Circle CVI) has moved quickly to position its cvi42 platform as an operational answer to the volume pressures created by a landmark coverage expansion from the US Centers for Medicare and Medicaid Services. On 10 September 2026, CMS finalised a new national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) that extends Medicare reimbursement to patients with asymptomatic severe aortic stenosis, a category previously excluded from routine coverage.
The policy shift follows the EARLY TAVR trial, which showed that early intervention in asymptomatic patients reduced a composite of death, stroke, or heart failure hospitalisation to 15.2%, compared with 24.2% under clinical surveillance. The FDA had already expanded its TAVR indication earlier in 2026 on the back of that evidence. CMS's NCD also removes coverage-with-evidence-development requirements for symptomatic patients, though those requirements remain in place for the newly covered asymptomatic cohort. The updated policy further codifies the heart team requirement: every case review must involve at least one cardiac surgeon and one interventional cardiologist with aortic valve experience.
What the coverage change means for imaging
The immediate operational consequence is a larger and more complex patient evaluation funnel. Every TAVR candidate requires a detailed pre-procedural CT workup covering aortic annulus sizing, coronary height assessment, calcification mapping, and iliofemoral access route analysis. Asymptomatic patients are often younger and face decades of valve durability questions, raising the stakes on planning accuracy. Circle CVI argues that programmes will need to process significantly more studies with the same imaging staff, making automation a practical necessity rather than a premium feature.
cvi42, the company's unified cardiovascular imaging platform, is deployed in more than 2,100 hospitals across more than 90 countries. The company says it covers the full structural heart pathway, including TAVR planning, transcatheter mitral valve replacement, and left atrial appendage occlusion planning, within a single software environment. Chief executive Erkan Akyuz said the platform was built to make imaging "faster, more consistent, and more scalable, so heart teams can turn expanded coverage into expanded access."
Chief medical officer Kevin Steel, DO, framed the clinical argument more directly: "As coverage expands to asymptomatic patients, imaging carries even more of the decision-making weight. Our goal with cvi42 is to give heart teams reproducible, quantitative answers in minutes, so clinical confidence scales as fast as case volume."
Market context and competitive landscape
The structural heart imaging software market has grown steadily alongside the expansion of TAVR programmes globally. Circle CVI competes in a space that includes both standalone cardiac CT planning tools and broader enterprise imaging platforms from larger radiology software vendors. The company's argument for platform consolidation, replacing separate cardiac MR, cardiac CT, and interventional planning point solutions with a single environment, reflects a wider industry trend toward reducing imaging IT complexity in large health systems.
The CMS ruling is significant because it is expected to bring TAVR into a broader range of hospitals, not only the high-volume quaternary centres that have historically dominated the procedure. Community hospitals and regional heart programmes building out structural heart services will face steeper learning curves and thinner imaging team bench depth, conditions that favour standardised, automated workflows. Whether Circle CVI can convert that tailwind into market share will depend on how quickly new and expanding programmes make software procurement decisions as the NCD takes effect.
The company will host a live webinar on 23 September 2026 covering the pre-procedural TAVR pathway under the finalised coverage policy, featuring a guest cardiovascular imaging specialist from Humana Centerwell in Orlando.