Wellington, New Zealand (PRWEB) September 18, 2012
FDA Approval of the first Automated Breast Ultrasound (ABUS) System for screening women with dense breasts represents a significant advancement in breast cancer screening, according to Matakina International, pioneers of the breakthrough Volpara breast density assessment software.
“We commend U-Systems on their leadership to gather the clinical data to support the FDA approval of automated breast ultrasound for breast cancer screening, giving women and their physicians an important new tool,” said Ralph Highnam, Ph.D., CEO of Matakina International. “With growing interest in breast density and improved screening for women with dense breast tissue, we strongly believe we are on the right path to help improve the early detection of breast cancer.
“This approval comes as breast density notification is becoming a reality in many states by virtue of legislation, as well as growing recognition of the clinical benefit of breast ultrasound when used to supplement screening mammography in women with dense breasts and normal mammograms. To support an increased dependence on supplemental imaging, Matakina has worked with some of the world’s leading imaging scientists to remove the subjectivity of physician assessment of density. The result is an accurate, reproducible measurement that gives referring physicians and patients confidence in the density determination process,” Dr. Highnam added.
Cleared by the FDA, HealthCanada, the TGA and CE-marked, Volpara is in use at sites across the globe helping radiologists assess breast density more objectively and helping them better consider who might benefit from additional screening. Volpara is a reliable tool which automatically generates objective, automatic measurement of volumetric breast density values under the Volpara Density Grade (VDG®) – a refined grading system which correlates with the American College of Radiology BIRADS Density Grading Classifications. Volpara is FDA cleared for all digital mammography units, and integration 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.
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