“For years, radiologists have known the challenges that tissue density presents to mammography, but did not have the ability to objectively and automatically quantify the actual breast density from the screening mammogram,” said Dr Ralph Highnam.
WELLINGTON, New Zealand (PRWEB) March 21, 2012
Matakina International Limited of Wellington, New Zealand, today announced that it 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.
Volpara is the only breast density quantification software that has multi-vendor FDA clearance and is approved for breast cancer screening by Health Canada, the agency responsible for assessing medical device safety, effectiveness and quality in Canada. In the United States, Volpara is cleared by the FDA to provide objective volumetric breast density values.
“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, GE and Fuji digital mammography systems. Volpara integrations with other digital mammography systems, CAD systems and mammography reporting system are also underway.
Founded to enable radiologists to give women the most accurate information possible regarding their breast health, Matakina International, Limited is the wholly owned sales and marketing arm of Matakina Technology Limited of New Zealand. Volpara’s founders and Board of Directors includes John Hood, PhD, former Vice Chancellor of the University of Oxford, UK, Ralph Highnam, PhD, former CEO of Mirada Solutions, one of the University of Oxford’s most successful spin-outs of recent times and co-author of the seminal book Mammographic Image Analysis; and Professor Sir Michael Brady, a serial entrepreneur who recently retired from the University of Oxford where he was Professor of Information Technology for 25 years.
Chris K. Joseph