Recent FDA Clearance Enhances Breast Density Assessment Performance and Expands the Types of Information Provided to Clinicians
WELLINGTON, NZ, January 30, 2019 – Volpara Solutions, Inc. recently announced that it has received FDA 510(k) clearance for technologies used in the Volpara®Density™ clinical application, the benchmark in 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 BI-RADS 4th and 5th Editions. With more than 100 peer-reviewed papers and more than 250 publications, VolparaDensity is the most clinically validated breast density assessment software in the world. It is CE-marked and cleared by the FDA, Health Canada, and the TGA.
Having an objective and validated measure of breast density is critical in the fight against breast cancer. 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 MRI depending on their breast density and risk profile.
“We are committed to continually evolving and improving VolparaDensity and our highly innovative suite of volumetric breast imaging tools designed to enhance clinical decision-making, workflow, and the early detection of breast cancer,” said Ralph Highnam, PhD, CEO, Volpara Solutions. “As more centers begin to adopt curved paddles, it is important for us to ensure that all women receive the most accurate and reproducible density assessment, regardless of the breast imaging system used.”
About Volpara Solutions
Founded with the goal of helping radiologists give women the most accurate information possible regarding their breast health, Volpara Solutions is the wholly owned sales and marketing arm of Volpara Health Technologies Limited of New Zealand. Available in most markets where breast cancer screening is commonplace, VolparaDensity provides an objective volumetric measure of breast density from both digital mammography and tomosynthesis data. VolparaEnterprise is a suite of quantitative breast imaging tools for personalized measurements of density, patient-specific x‑ray dose, breast compression, breast positioning, and other factors designed to provide critical insight for breast imaging workflow.
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Chris K. Joseph