Volpara gets FDA go-ahead on breast density assessment aid

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Volpara Solutions has won FDA 510(k) clearance for software designed to help radiologists meet the BI-RADS Atlas fifth-edition requirement to provide an overall assessment of the volume of attenuating tissues in the breast.

A press release from the New Zealand-based company says the product line, Volpara Density Maps, helps point out the likelihood that a lesion may be obscured by especially dense tissue.

Volpara Density Maps present the 3D quantitative volumetric information created by the  VolparaDensity algorithm in a 2D image that is available as an additional DICOM secondary capture image, according to the company.

Volpara further explains that the algorithm measures the compressed thickness and volume of dense tissue, which “enables the software to highlight specific parts of the breast tissue that are especially dense, including marking the densest 1-cm 2 region of the image that might warrant closer inspection due to the masking risk.”