UnitedHealthcare and Cigna Coverage for Cleerly LABS Advanced Plaque Analysis has Started

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

Partner News | Published: Tuesday, October 21, 2025

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Cleerly, the leader in artificial intelligence (AI)-based advanced cardiovascular imaging, recently announced that groundbreaking coverage policies from UnitedHealthcare and Cigna for Cleerly^® LABS™ advanced plaque analysis went into effect on Oct. 1, 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. 

As of Oct. 1, 2025, patients 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 coronary computed tomography angiography (CCTA) is considered reasonable and medically necessary as a diagnostic study when: 

• The patient has acute or stable chest pain with no known coronary artery disease (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  

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 with a .96 AUC1,2 and near-infrared spectroscopy 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 UnitedHealthcare 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 Oct. 1, 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. 

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