Company Spotlight: Bunkerhill Contrast CAC - Opportunistic Screening on Routine Scans

We unpack the FDA 510(k) summary for Bunkerhill Contrast CAC, an AI tool cleared to opportunistically detect and quantify coronary artery calcium on routine contrast-enhanced chest CTs. We discuss the shift from non-contrast to contrast imaging, the pivotal performance data, and what it means for clinical workflows.

Key points

• Cleared for adults aged 30 years and above to detect and estimate the quantity of coronary artery calcification.
• Specifically designed to analyze non-gated, contrast-enhanced chest CT images, unlike its predicate device which uses non-contrast scans.
• Outputs an estimated volume score in mm3 rather than traditional Agatston units.
• Pivotal testing demonstrated a sensitivity of 0.957 and specificity of 0.929.
• A 50-case bridging study comparing contrast to non-contrast images showed a mean bias of -4.36 mm3.
• The software is intended as adjunctive information only and does not replace the physician's evaluation or the original patient report.

Source: FDA 510(k) summary K260166: Bunkerhill Contrast CAC (BunkerHill Health) - U.S. Food and Drug Administration, 2026

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: BunkerHill Health (bunkerhillhealth.com) · Product: Bunkerhill Contrast CAC · FDA 510(k) K260166

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-bunkerhill-contrast-cac-opportunistic-screening-on-r-dfb2f3