Volpara Receives Regulatory Clearances in Japan and Taiwan
WELLINGTON, New Zealand, Nov. 20, 2017 /PRNewswire/ -- Volpara announced today that it has received regulatory clearances for its suite of quantitative breast imaging tools in Japan and Taiwan. In Japan, the full Volpara®Enterprise™ suite of products has received regulatory approval as a Class II medical device. In Taiwan, Volpara®Density™ and Volpara®Dose™ have received regulatory clearance as a Class II medical device from the Taiwan Food and Drug Administration (TFDA). VolparaEnterprise software is not classified as a medical device in Taiwan, and does not require regulatory approval.
Japan has approximately 65 million women and some 5 million are screened for breast cancer using mammography each year. It is estimated that Japan has 3,200 mammography machines, making it one of the world's largest users of mammography outside the US. The incidence of breast cancer is rapidly increasing in Japan, with breast cancer now one of the leading causes of cancer death, accounting for 20.4% of all new cancers. For this reason, breast cancer screening and increasing the compliance surrounding screening are areas of focus for the government. Women aged 40-69 are encouraged to undergo a breast screen every two years, and breast density notification is under discussion.
Hirofumi Namba, president of Breast Healthcare, Volpara's Japanese distributor, will immediately launch the products into the Japanese market and will attend the Radiological Society of North America (RSNA) meeting, November 26-December 1, 2017 (Volpara Booth - South Hall #2571). Breast Healthcare already has multiple research sites installed and active with VolparaDensity software, including Hokkaido Cancer Centre, Niigata Cancer Centre, Hokuto Hospital and Showa University School of Medicine; and formally introduced VolparaEnterprise software at the Japanese Association of Breast Cancer Screening meeting in Tokushima last week.
Taiwan has a target population for screening of more than 670,000 women. It is estimated that Taiwan has around 300 digital mammography machines, and it is one of world's largest users of computer-aided detection in mammography outside of the US, in line with its status as a leading adopter of computer technology. The incidence of breast cancer is also rapidly increasing in Taiwan, with the number of cases almost doubling in the last 20 years and forecast to approach Western levels over the next 15 years. For this reason, breast cancer screening and increasing the compliance surrounding screening is an area of focus for the government. Women aged 45-69 are encouraged to undergo a breast screen every two years.
Volpara has two research sites in place, including Changhua Christian Hospital in Changhua City, which has commenced an evaluation of VolparaEnterprise Analytics, and set to be the first VolparaEnterprise customer in Asia. The Tri-Service General Hospital in Taipei has been using VolparaDensity in clinical research since 2014.
"We know that there are a higher proportion of women with dense breasts in these countries compared to the West, which may contribute to the rising incidence of breast cancer and missed cancers," said Ralph Highnam, PhD, Chief Executive Officer of Volpara. "We are pleased to continue expanding the global reach of Volpara's quantitative breast imaging tools, which are designed to help maintain accuracy and consistent quality in breast screening. We believe this will help improve the early detection of breast cancer in Japan and Taiwan."
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