Health Canada Clears Volpara
We are proud to announce that Matakina has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the Volpara breast imaging software in Canada. Approval was based on extensive clinical evidence and includes the following indication: Volpara calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values to aid radiologists in the assessment of breast tissue composition.
The Volpara breast imaging software is the first FDA cleared multi-vendor density tool approved for breast cancer screening by Health Canada, the agency responsible for assessing medical device safety, effectiveness and quality in Canada.
“For years, radiologists have known the challenges that tissue density presents to mammography, but they did not have the ability to objectively and automatically quantify the actual amount of breast density from the screening mammogram,” said Dr Ralph Highnam, CEO, Matakina International, Ltd. “With this approval from Health Canada, we are proud to help improve Canadian radiologists understanding of breast density and assist them in helping patients to make appropriate screening decisions.”
Breast tissue density has not only been linked to an increased risk of breast cancer, it also decreases the sensitivity of the mammogram and thereby may impact early detection. Several large studies have confirmed that as tissue density increases the accuracy of mammography decreases. Thirty-five percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks the appearance of tumors (Boyd et al 2007, NEJM). Since both dense breast tissue and cancer appear white on a mammogram, finding cancers can be analogous to looking for a snowball in a snow storm.
Volpara provides radiologists a reliable tool to automatically generate objective volumetric breast density values, the FDA-cleared Volpara breast imaging software computes volumetric breast tissue density from digital mammograms. Volpara software assists radiologists by providing an objective, automatic measurement of volumetric breast tissue density and provides the Volpara Density Grade that is correlated with the American College of Radiology BIRADS Density Grading Classifications. Volpara is currently available for Hologic, Siemens, Fuji and GE digital mammography systems. Volpara integrations with other digital mammography systems, CAD systems and mammography reporting system are also underway.