January 31, 2019 — Volpara Solutions Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for new technologies used in the Volpara Density clinical application for breast density assessment. The updated version of VolparaDensity more accurately reflects breast density from images captured using the Hologic SmartCurve system.
This VolparaDensity update also supports additional breast imaging systems, such as the Siemens Mammomat Fusion and Mammomat Revelation® systems.
As one of the clinical applications within Volpara Enterprise software, VolparaDensity provides radiologists with automated, objective volumetric breast density assessments and a breast density category shown to correlate to the Breast Imaging-Reporting and Data System (BI-RADS) 4th and 5th Editions. It is CE-marked and cleared by the FDA, Health Canada and the TGA.
Women with dense breasts not only have an increased risk of breast cancer but are also impacted by lower mammographic sensitivity that dramatically reduces the chances of early detection. Several large studies have confirmed that as density increases the accuracy of mammography decreases. Thus, women with dense breasts are candidates for additional screening with either ultrasound or magnetic resonance imaging (MRI) depending on their breast density and risk profile.
For more information: www.volparasolutions.com
December 10, 2025 
