Cleerly Secures Broader Reimbursement as Sex-Specific Cardiac Risk Data Gains Traction

Cleerly is in focus this week as the company highlighted broader reimbursement access for its AI-enabled coronary plaque analysis platform. The company says its technology uses non-invasive coronary CT angiography (CCTA) to differentiate between calcified plaque and higher-risk soft, non-calcified plaque that may be missed by traditional tests.

Cleerly reports that its offering is now supported by a new Category I CPT code and expanded insurance coverage, making the service reimbursable for a majority of insured lives in the U.S. This development could ease reimbursement friction for providers, supporting higher clinical adoption, more predictable procedure volumes, and clearer revenue visibility.

The company is also drawing attention to sex-specific insights from its CONFIRM2 cardiovascular study, which includes roughly 50% female participation across 12 countries. Study findings suggest that certain coronary plaque features may be associated with a higher risk of major adverse cardiovascular events in women than in men, underscoring limitations of one-size-fits-all risk models.

Cleerly is positioning its AI-driven CT and CCTA-based capabilities as tools to enable more tailored and equitable cardiovascular risk assessment, particularly in women’s heart health. If clinicians and payers increasingly adopt such nuanced, image-based risk stratification, Cleerly’s technology could gain relevance in evolving guidelines and outcomes-focused care models.

Combined, the expanded reimbursement framework and emphasis on sex-specific risk profiling enhance Cleerly’s competitive stance in AI-enabled cardiac imaging and diagnostics. The week’s developments point to a maturing commercialization environment for the company, with growing clinical validation and payer support potentially underpinning its long-term growth prospects.