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Heartflow Receives FDA 510(k) Clearance for Next-Gen Heartflow Plaque Analysis Platform
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Heartflow Receives FDA 510(k) Clearance for Next-Gen Heartflow Plaque Analysis Platform
Mar 10, 2026 8:22 PM

04:37 PM EDT, 09/22/2025 (MT Newswires) -- Heartflow ( HTFL ) said late Monday it received US Food and Drug Administration 510(k) clearance for its next-gen Heartflow Plaque Analysis platform featuring an updated algorithm that shows a 21% improvement in plaque detection for better management and diagnosis of coronary artery disease.

The latest technology also comes with an expanded nomogram and offers 3D color-coded visualization of plaque type, distribution, and volume, according to a statement.

The company said the AI-powered platform will be covered by Cigna Group ( CI ) across all lines of its businesses, including commercial and medicare advantage plans, starting Oct. 1.

Heartflow ( HTFL ) shares rose over 2% during after-hours trading.

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