The clearance includes Cleerly PLAQUE, an updated plaque algorithm powered by CONFIRM2 data
DENVER, October 30, 2026 – Cleerly, a leader in advanced cardiovascular imaging analysis, today announced that the U.S. Food and Drug Administration (FDA) has cleared an updated version of Cleerly LABS, the company’s analysis software. The company also received clearance for the latest generation of Cleerly’s PLAQUE algorithm, which is now trained on a more diverse dataset from the CONFIRM2 Registry. CONFIRM2 data enriches the model with approximately 50% female participants and a cohort of 6,550 individuals from 46 countries, supporting broader applicability across patient populations.
These products continue to build on Cleerly’s seamlessly integrated ecosystem to give clinicians and patients comprehensive plaque and stenosis outputs.
“These clearances reflect our commitment to building tools that perform well across the patients clinicians actually see,” said Michal Sofka, Chief Technology Officer at Cleerly. “Informing the plaque algorithm with CONFIRM2 data makes our analysis more broadly applicable, and the efficiency improvements help analysts work through studies more quickly.”
The update will be available to customers in November 2026, along with Cleerly PLAQUE. Users will receive the update automatically, with no action needed.
About Cleerly
Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive CT imaging. Cleerly’s approach is grounded in science, based on millions of images from over 40,000 patients. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: cleerly.com.
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