WELLINGTON, New Zealand, Nov. 18, 2010 /PRNewswire/ — Offering
radiologists a reliable and cost-effective tool to generate
automatic volumetric breast density values, Volpara, Ltd.,
announced today that it has received clearance from the U.S. Food
& Drug Administration (FDA) for its Volpara™ breast
imaging software. Volpara, a subsidiary of Matakina Technology,
Limited of New Zealand, is responsible for commercial operations in
the United States.
Automatically computing volumetric breast tissue density from
screening mammograms, Volpara software assists radiologists by
providing objective, automatic and robust measurement of volumetric
breast tissue density. Cleared for use with digital
mammography systems, Volpara is currently available for Hologic and
GE digital mammography systems with other systems undergoing
validation.
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.
“Radiologists and imaging scientists have known for years the
challenges that tissue density presents to mammography, but there
haven’t been the means to objectively and automatically quantify
the actual amount of breast density from the screening mammogram,”
said Dr Ralph Highnam, CEO, Volpara, Ltd. “Volpara will
improve radiologists’ understanding of breast composition and
assist them in helping patients to make appropriate screening
decisions.”
Radiologists currently use the Breast
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