FDA clears Volpara breast density calculating software

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The FDA has given clearance to Volpara to sell its Volpara software program, which automatically calculates breast tissue density based on mammography screenings.

Volpara automatically inputs digital image characteristics and standard information captured in mammography exams into an algorithm to measure volumetric breast tissue density. The company touted its software as an objective alternative to the four subjective BI-RADS density categories and as enabling radiologists to compare patients' historic volumetric measurements.

Volpara, the sales and marketing subsidiary of Wellington, New Zeland-based Matakina Technology, said its Volpara software is currently available only for GE and Hologic digital mammography systems.