Medical Systems News

FCRm gains FDA Approval

Fujifilm Medical Systems USA has received approval from the Food and Drug Administration (FDA) for its digital mammography solution - Fujifilm Computed Radiography for Mammography (FCRm) - to be sold in the United States1.

Fujifilm Computed Radiography for Mammography (FCRm) was one of seven mammography systems tested in the recent Digital Mammographic Imaging Screening Trial (DMIST) involving more than 49,000 women in the USA. This trial revealed that digital mammography may be more accurate than film mammography in certain groups of women: women with dense breasts, or who are pre - or perimenopausal or who are younger than age 502.

Overseas, more than 2800 Fujifilm FCR mammography systems have been installed throughout Europe, Asia, South America, the Middle East, Africa and Oceania3.

In regard to the European Guidelines for Digital Mammography, the (UK) National Health Service Breast Screening Programme (NHSBSP), stated on its website that: “Only one of the computed radiography (CR) systems tested by the NHSBSP meets these standards4. However, testing of new designs is ongoing”5. That one unit is the Fujifilm FCR Profect CS6.

Locally, over 30 Fujifilm FCR mammography systems are installed and all components are registered with the TGA (Therapeutic Goods Administration) to enable sale in Australia7 . Both NSW BreastScreen and Victoria BreastScreen have purchased the Fujifilm FCR Profect CS, with the Victorian unit installed on a mobile bus servicing rural Victoria8.

If you have any questions or require any more information about Fujifilm Computed Radiography for Mammography (FCRm) systems or any other Fujifilm products please do not hesitate to contact us viafcr@Fujifilm.com.au.

1 www.fujimed.com
2 www.cancer.gov/newscenter/pressreleases/DMISTrelease
3 www.healthimaging.com/content/view/4435/89/
4 refers to image quality and dose standards of the European Guidelines
5 www.cancerscreening.nhs.uk/breastscreen/publications/me-ep04.html
6 Other systems trialled in the NHSBSP used DR technology
7 www.tgasime.health.gov.au/SIME/ARTG/ARTGPublicWeb.nsf/DEVpublic?SearchView&Query=Fujifilm&start=1&searchOrder=4&searchMax=1000&searchWV=0&searchFuzzy=0
8 BSV Digital Newsletter, Issue 3, May 2006, Rural Broadband Digital Mammography Project

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