Company Spotlight: Circle CVI cvi42 Coronary Plaque - Automating AI Plaque Quantification

We unpack the FDA 510(k) summary for Circle Cardiovascular Imaging's cvi42 Coronary Plaque Software Application. This episode explores the device's machine learning validation numbers, its specific plaque measurements, and how it compares to its predicate devices for cardiac CT analysis.

Key points

• The cvi42 Coronary Plaque module is a Software as a Medical Device that uses AI to help physicians quantify coronary plaque on CCTA scans.
• Validation testing showed a 0.99 Pearson Correlation Coefficient for calcified plaque compared to expert annotators, though the correlation for low-attenuation plaque was lower at 0.74.
• The software measures volumes and burdens for calcified, non-calcified, and low-attenuation plaque, along with metrics like the Remodeling Index.
• Clearance was based on substantial equivalence to two predicate devices: Circle's own cvi42 Auto and Cleerly Labs.
• The 510(k) summary does not disclose the exact number of patients or scans used in the validation dataset, noting only that 100% came from US sources.

Source: FDA 510(k) summary K251027: cvi42 Coronary Plaque Software Application (Circle Cardiovascular Imaging) - U.S. Food and Drug Administration, 2025

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Circle Cardiovascular Imaging (circlecvi.com) · Product: cvi42 Coronary Plaque Software Application · FDA 510(k) K251027

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-circle-cvi-cvi42-coronary-plaque-automating-ai-plaqu-13c65a