Volpara gets FDA nod for new density uses

By AuntMinnie.com staff writers

January 31, 2019 -- Breast imaging software developer Volpara Solutions has received clearance from the U.S. Food and Drug Administration (FDA) to market an updated version of its VolparaDensity software that is designed to be used with images acquired with SmartCurve paddles from Hologic.

VolparaDensity gives users automated, objective volumetric assessments of breast density, and it assigns tissue a breast density category that correlates to BI-RADS categories. The application is available as a feature in the company's VolparaEnterprise software.

SmartCurve is Hologic's breast stabilization system for providing more comfortable mammograms without negatively affecting image quality, workflow, or dose. The updated version of VolparaDensity that has been cleared by the FDA now more accurately reflects breast density from images acquired with SmartCurve.

The updated version also supports other mammography systems, such as the Mammomat Fusion and Revelation systems from Siemens Healthineers.

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