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[HEALTH] · United States · 3 sources

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Part of situation: FDA clearance of cardiovascular AI imaging tools (2 clusters)

FDA clears AI-powered cardiovascular imaging software

FDA clearance AI cardiovascular imaging fractional flow reserve coronary CT angiography medical software

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Elucid’s FFR-IQ software. This technology allows for the noninvasive estimation of fractional flow reserve (FFR) from coronary CT angiography (CCTA).

By incorporating coronary anatomy and plaque composition, the software supports individualized assessments and treatment decisions. It aims to help physicians identify patients who require invasive evaluation or revascularization, potentially reducing unnecessary cardiac catheterizations. In the ELUCIDATE FFR-CT study, the software demonstrated a sensitivity of 92.2% and a specificity of 93.1%.

Additionally, Coreline Soft has received FDA clearance for its ‘AVIEW Aorta Metrics,’ marking the company’s 13th approved product.

Entities

Coreline Soft · Elucid · FDA · U.S. Food and Drug Administration

Sources

Coreline Soft receives FDA clearance for ‘AVIEW Aorta Metrics,’ securing 13th approved product [www.thebionews.net]
FDA Clears Elucid's FFR-IQ for Noninvasive FFR-CT Assessment [www.hmpgloballearningnetwork.com]
Radiology Roundup of FDA News: October 18 — October 24 [www.diagnosticimaging.com]