Heartflow Announces FDA 510(k) Clearance and Launch of Next Generation Heartflow Plaque Analysis Platform - HeartFlow (NASDAQ:HTFL)

Heartflow Announces FDA 510(k) Clearance and Launch of Next Generation Heartflow Plaque Analysis Platform - HeartFlow (NASDAQ:HTFL)

MOUNTAIN VIEW, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (NASDAQ:HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and the platform is now available. The technology features an updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualiz…

Hearflow’s next-generation Plaque Analysis algorithm gains US FDA clearance - Cardiovascular News

Heartflow Plaque Analysis Heartflow has received US Food and Drug Administration (FDA) 510(k) clearance for its next-generation Heartflow Plaque Analysis algorithm and the platform is now available. The technology features an updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualisation of plaque type, volume, and distribution. Heartflow also announced that Heartflow Plaque Analysis will be covered by Cigna across all of…

Heartflow secures FDA clearance for updated plaque analysis platform

Heartflow has secured the US Food and Drug Administration (FDA) clearance for the latest version of its Heartflow Plaque Analysis platform.The post Heartflow secures FDA clearance for updated plaque analysis platform appeared first on Medical Device Network.

Cutting Through How AI-Enhanced HeartFlow Plaque Analysis Gains FDA Approval and Cigna Backing to Transform Cardiac C...

'AI in Healthcare: HeartFlow's FDA Approval and Cigna Coverage Marks a Milestone in Cardiac Care' 'By ' In a significant development for the healthcare industry, HeartFlow, a leader in AI-enhanced cardiovascular technology, has recently obtained FDA 510(k) clearance and subsequently launched its next-generation HeartFlow Plaque Analysis platform. This AI-powered system promises to revolutionize the assessment and management of coronary artery di…

Heartflow Receives FDA Clearance for Next-Gen AI Plaque Analysis, Expands Cigna Coverage

What You Should Know:  – Heartflow, a leader in AI technology for coronary artery disease (CAD), has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and platform.  – The technology features an updated algorithm, an expanded nomogram, and advanced 3D color-coded visualization of plaque, empowering clinicians with crucial insights for confident care decisions. In addition, Hear…