FDA gives Volpara clearance for breast software

AuntMinnie.com staff writers
Nov 8, 2015

Breast imaging software developer Volpara Solutions received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VolparaDensity breast imaging software.

The new clearance covers VolparaDensity version 3.1, which has been specifically designed to correlate with the new fifth edition of the BI-RADS Atlas. The new atlas includes a requirement that any possible attenuating breast tissue be assessed.

The development of Volpara's new software included a reader study used to optimize VolparaDensity performance to the BI-RADS fifth edition.

Volpara will showcase its latest software and more at RSNA 2015.

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