Volpara wins FDA clearance for new version of dense-breast imaging aid

The FDA has given 510(k) clearance to an updated version of breast-density assessment software from New Zealand-based Volpara Solutions.

VolparaDensity 3.1 is designed to mesh with the American College of Radiology’s fifth-edition BI-RADS Atlas released in January 2014, according to Volpara’s announcement.

FDA cleared the first version of the software in 2010, and Volpara says the product line is currently in use in 31 countries.

The software helps radiologists objectively assess density from digital mammography and tomosynthesis, guiding them on which women might benefit from additional imaging.

The company says the new version measures the compressed thickness and volume of dense tissue to show when small regions of “focal density” present a masking risk.

Its announcement cites a NEJM study showing that 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as dense tissue tends to conceal tumors.