Heartflow has secured the US Food and Drug Administration (FDA) 510(k) clearance for the latest version of its Heartflow Plaque Analysis platform.
The updated technology is said to enhance coronary artery disease (CAD) diagnosis with an improved algorithm.
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According to Heartflow, the platform offers advanced 3D visualisation of plaque characteristics and distribution, as well as helps clinicians in making informed care decisions.
US-based health insurance company Cigna has announced nationwide coverage for the Heartflow Plaque Analysis across all its business lines.
Cigna becomes the second national insurer to adopt the coverage, which includes commercial and medicare advantage plans, starting next month.
The move aligns with guidelines from radiology benefit manager EviCore, following UnitedHealthcare’s similar policy update.
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By GlobalDataHeartflow president and CEO John Farquhar said: “Heartflow is proud to lead the way in coronary plaque analysis with our Next Gen platform, delivering the most representative visualisation and context available for assessing patients’ disease and risk.
“Cigna’s decision to cover Heartflow Plaque Analysis is a testament to the power of our technology to positively impact care for its members across the US.”
According to the company, its Plaque Analysis tool is the only FDA-approved AI-powered plaque quantification system, offering a 95% agreement rate with the gold standard intravascular ultrasound (IVUS), based on blinded core lab adjudication.
The new algorithm shows a 21% improvement in plaque detection over the first-generation version, enhancing CAD diagnosis and management capabilities.
The updated platform leverages data from approximately 273,000 patients, offering a significantly larger dataset than existing plaque quantification studies.
Cigna’s updated coverage policy will be applicable for patients experiencing acute or stable chest pain and mild-to-moderate coronary artery narrowing as identified on coronary computed tomography angiography (CTA).
Last year, HeartFlow launched the previous version of its plaque analysis platform, focused on enhancing patient risk assessment in suspected CAD.
