New VolparaDensity software update obtains FDA approval
February 7, 2019 · Staff News Brief
Volpara Solutions of Wellington, New Zealand, has received U.S. Food and Drug Administration 510(k) clearance for an update to its VolparaDensity™ breast density assessment software. The software update more accurately reflects breast density from images captured using the Hologic SmartCurve™ system.
VolparaDensity, available as a feature of VolparaEnterprise™ software, produces automated, objective volumetric assessments of breast density. It also assigns tissue a breast density category that correlates to BI-RADS categories.