FDA clears Volpara breast density software

The U.S. Food and Drug Administration (FDA) has cleared the Volpara breast density software from Volpara, Ltd., a subsidiary of Matakina Technology of Wellington, New Zealand.

The Volpara software automatically computes a patient's breast density based on information acquired during her screening mammograms. Research studies have demonstrated that tissue density can be a major risk factor for breast cancer, and traditional x-ray-based mammography systems perform poorly in women with dense breasts.

Volpara produces a numerical breast density value from 0% to 40%. Breast imagers can then use this information to decide whether a patient should receive additional adjunctive breast imaging modalities besides mammography, such as breast MRI, ultrasound, or nuclear breast imaging technologies.

Volpara generates breast density values in seconds, which means that healthcare providers can order additional imaging modalities while the patient is still at the screening facility, according to Ralph Highnam, CEO of Volpara.

Volpara plans to demonstrate the software at the upcoming RSNA show in the booths of multiple vendors, including developers of PACS and mammography information system software, as well as vendors of conventional and adjunctive mammography imaging technologies, Highnam said. The software works with images from multiple full-field digital mammography (FFDM) systems.

Related Reading

Matakina tackles breast density problem with Volpara software, February 3, 2010

U.K. scientist wins medal, January 19, 2010

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