UnitedHealthcare and Cigna Coverage for Cleerly LABS Advanced Plaque Analysis Begins October 1st

Major Payors Embrace AI-Powered Cardiac Imaging, Expanding Access to Advanced Plaque Analysis

DENVER--(BUSINESS WIRE)--Cleerly, the leader in AI-based advanced cardiovascular imaging, today announced that groundbreaking coverage policies from UnitedHealthcare and Cigna for Cleerly® LABS™ advanced plaque analysis will go into effect on October 1st, 2025. These landmark decisions mark a new era in cardiac care, bringing AI-guided quantitative coronary CT angiography (AI-QCT)/Coronary Plaque Analysis (AI-CPA) within reach of millions of Americans.

Starting October 1st, 2025, patients will have access through streamlined coverage criteria that mirrors Medicare's established local coverage determinations and EviCore’s recently updated guidelines. AI-QCT/AI-CPA using CCTA is considered reasonable and medically necessary as a diagnostic study when:

• The patient has acute or stable chest pain with no known CAD and is eligible for CCTA, AND
• CCTA classifies patient as:
  • Intermediate risk OR
  • CAD-RADS 1, CAD-RADS 2 or CAD-RADS 3, category on CCTA, AND
• Cardiac evaluation is negative or inconclusive for acute coronary syndrome (ACS)

Cleerly LABS’ advanced plaque analysis stands alone as the only AI-based plaque tool with peer-reviewed data comparing it to multiple industry-leading invasive imaging modalities, including intravascular ultrasound (IVUS) with a .96 AUC^1,2 and near-infrared spectroscopy (NIRS) with a .97 AUC¹. Cleerly's advanced plaque analysis was also validated against Level III readers, and an extensive list of post-market published clinical data can be found on cleerlyhealth.com.

"We're witnessing a paradigm shift in how we approach heart disease," said James K. Min, MD, founder and CEO of Cleerly. "With United Healthcare and Cigna recognizing the power of AI-driven advanced plaque analysis in their coverage policies, they are not only embracing innovation, they are helping to redefine standards of care consistent with the latest clinical evidence to improve patient outcomes. Starting October 1st, doctors can base treatment decisions on precise, quantitative plaque data that was previously available only through invasive procedures."

With this coverage breakthrough, more patients will benefit from Cleerly's ability to quantify and characterize coronary plaque noninvasively. The platform's detailed analysis of plaque composition gives cardiologists the specific data they need to personalize and optimize treatment, while helping to avoid the unnecessary risks and costs associated with invasive diagnostic procedures.

Visit www.cleerlyhealth.com to learn more.

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: cleerlyhealth.com.

Omori, Hiroyuki, et al. Determination of lipid-rich plaques by artificial intelligence-enabled quantitative computed tomography using near-infrared spectroscopy as reference. Atherosclerosis, vol. 386, 2023 Data on file