FDA approves Circle's new cardiac CT function module

The U.S. Food and Drug Administration (FDA) has granted 510(k) premarket approval to Circle Cardiovascular Imaging's cardiac CT Function software application.

The approval is Circle's sixth 510(k) for advanced cardiac image postprocessing software, according to the firm. It coincides with the company's cvi42 v6.1 release, which includes machine-learning AI enhancements and upgrades for coronary analysis, aortic valve cusp point detection, integrated reporting, and web viewer capabilities.

Cvi42 features tools that help clinicians quantify cardiac function and flow, visualize tissue abnormalities, automatically characterize and quantify plaque within the coronary arteries, and conduct preprocedural planning for transcatheter aortic valve replacement and transcatheter mitral valve replacement.

Circle plans to unveil the enhanced cvi42 Core CT platform at the Society for Cardiovascular Computed Tomography (SCCT)'s annual meeting in Washington, DC, in July.