FDA Approves Fuji's Digital Mammography System for Use in the U.S.; High Performance, Cost-Effective System Expected to Spur Adoption, Make Digital Mammography More Widely Accessible in the U.S.

STAMFORD, Conn. -- Digital mammography, found in a major clinical study to be better than conventional film-screen mammography for detecting breast cancer in certain groups of women, will soon become accessible to more women in the United States. The Food and Drug Administration (FDA) has just approved what is already the world's most widely-used digital mammography technology to be sold now in the United States. FUJIFILM Medical Systems USA can now offer the benefits of its high performance, cost-effective digital mammography system, Fuji Computed Radiography for Mammography (FCRm), to facilities nationwide. E[acute accent]A landmark clinical study of 49,528 women found that digital mammography has significant benefits over conventional film-screen mammography in detecting breast cancer in three groups of women: women under 50, pre- and peri-menopausal women, and women with dense breasts. These three sub-groups represented nearly 65 percent of the women in the study, the American College of Radiology Imaging Network's Digital Mammographic Imaging Screening Trial (ACRIN-DMIST), which was funded by the National Cancer Institute (NCI) and completed last year. E[acute accent]"The kind of cancers that were found by digital mammograms and not by film were important breast cancers; they're the kind that kill women," said Dr. Etta D. Pisano, Kenan Professor and Director UNC Biomedical Research Imaging Center and lead author of the study. "Dense-breasted women tend to be at especially high risk for breast cancer, and they are among the hardest to screen with conventional film x-rays." E[acute accent]However, only about 12 percent of mammography facilities in the U.S. currently offer digital mammography technology; affordability has been one of the greatest obstacles to its widespread adoption thus far. E[acute accent]"The demand for digital--from both patients and mammography facilities alike-- is clearly on the rise as a result of the ACRIN-DMIST findings," said Clay Larsen, Fuji's Vice President, Marketing and Network Business Development. "With its unique design and straightforward implementation requirements, Fuji CRm is positioned to break the cost barrier associated with other full-field digital mammography (FFDM) systems, and make this advanced technology accessible to more women throughout the United States." E[acute accent]While traditional film screen mammography remains a very effective tool for detecting breast cancer, more breast imaging facilities have been actively seeking a digital screening solution since last fall's announcement of the ACRIN-DMIST results, which revealed significant benefits of digital for a considerable percentage of the screening population. With its versatile and cost-effective FCRm, Fuji is anticipating becoming the digital system of choice for many facilities and is looking forward to mirroring its world leadership position here in the U.S. E[acute accent]"Even before the ACRIN-DMIST announcement, the trend was toward digital, primarily because of the functional benefits it offers," Dr. Pisano noted. "Our results may have accelerated that movement to a degree, but the availability of a more affordable and versatile digital option, like that offered by Fuji's CRm, is likely to speed adoption even more." E[acute accent]Unlike other digital mammography systems, Fuji's computed radiography for mammography does not require replacing the existing mammography x-ray unit. This significantly lowers facilities' conversion costs. Instead of a complete system overhaul, with FCRm the film cassettes are simply replaced with FCR cassettes. After the exam, the digitally acquired information is sent to the diagnostic workstation for interpretation. E[acute accent]In addition to the benefits of digital noted in the ACRIN-DMIST, digital mammography also brings other benefits to the patient. With digital mammography, x-ray images can be displayed on a computer workstation, allowing the radiologist to magnify or optimize a particular area and adjust the contrast of the image. This can reduce the number of extra images and exposures that are sometimes required during the diagnostic process. E[acute accent]Digital mammography also enables the technologist to immediately see if the image was taken correctly; freeing the patient from waiting until films are developed or from being called back for additional x-ray exposures after they've gone home. Moreover, since the images are stored and retrieved electronically, it is easy to facilitate long-distance consultations with other mammography specialists, and to compare current mammograms to a patient's previous mammograms, as well as to breast ultrasound or breast MR exams that may have been acquired. E[acute accent]"Screening mammography is still recognized as the most effective tool available for the early detection of breast cancer," noted Larsen. "It's critical that women continue to get their mammograms whether their facility offers film or digital technology. But with the approval of Fuji's digital mammography system, we're very much looking forward to the opportunity to enable more and more facilities to adopt digital, thereby making it readily accessible to as many women as possible, with the ultimate goal of saving more lives."

E[acute accent]About FUJIFILM Medical Systems USA, Inc.

E[acute accent]As one of the Fuji Photo Film family of companies with 70 years of imaging experience and almost $25 billion in sales, FUJIFILM Medical Systems is a leading provider of diagnostic imaging products and network systems to meet the needs of healthcare facilities today and well into the future. Fuji's family of Imaging Systems products and technologies--including digital x-ray, women's healthcare imaging, dry imagers, and conventional x-ray film and equipment--are tailored to suit many different applications for a variety of imaging environments. The pioneer of computed radiography (CR), Fuji remains the market leader in digital x-ray with products that are clinically proven and constantly evolving to set the standard in digital imaging innovation. Fuji is headquartered in Stamford, CT. More information is available at www.fujimed.com.

E[acute accent](C) 2006 FUJIFILM Medical Systems USA, Inc.