Company Spotlight: Cleerly LABS (v2.0) - AI for Coronary Plaque Analysis

In this episode, we unpack the FDA 510(k) summary for Cleerly LABS (v2.0), an AI tool for analyzing cardiac CT scans. We explore how it separates deep learning vessel segmentation from rule-based measurements, and what its clearance means for cardiology workflows.

Key points

• Cleerly LABS (v2.0) is a web-based software application that uses deep learning to segment coronary arteries from cardiac CT data.
• The final measurements for plaque and stenosis are simple rule-based mathematical calculations, not machine-learning based.
• The FDA clearance (K242338) is based on substantial equivalence to an earlier version (K202280) and did not require new clinical testing.
• The document warns that interpolated data created by the software may make diseased tissue look healthy if the pathology is near or smaller than the scanning resolution.
• The software generates a CORONARY Report, which is explicitly not intended to be the final physician report used in diagnosis.

Source: FDA 510(k) summary K242338: Cleerly LABS (v2.0) (Cleerly) - 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: Cleerly (cleerlyhealth.com) · Product: Cleerly LABS (v2.0) · FDA 510(k) K242338

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-cleerly-labs-v2-0-ai-for-coronary-plaque-analysis-7b8f97