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Fujifilm to Begin Clinical Trials of 3D Mammography in the U.S.
Date:11/27/2011

CHICAGO, Nov. 27, 2011 /PRNewswire/ -- A year after clinical trials began in Japan, FUJIFILM Medical Systems U.S.A., Inc. today announced at the Radiological Society of North America (RSNA) 2011 Annual Meeting that clinical trials for their 3D Digital Mammography(1) technology are about to commence in the United States. The medical imaging and informatics company is currently installing 3D mammography systems at renowned medical centers across the country with plans to begin trials as early as December 2011.

"When it comes to the early detection of breast cancer, radiologists will benefit from powerful 3D technology to elevate their diagnostic confidence using an average glandular dose that is equivalent to 2D Full Field Digital Mammography (FFDM), increase their workflow, and give their patients improved outcomes," explains David Hotchkiss, Director of Modality Solutions Marketing at Fujifilm. "After thorough evaluation of needs of the patients and clinicians, we believe that, when approved by the FDA, Fujifilm's 3D Digital Mammography has the potential to become the standard of care. We remain committed to improving our breast screening technologies, and we are confident that this will be the screening technology of choice."

Currently commercially available for sale and in use in Europe, Fujifilm's 3D Digital Mammography is an innovative breast screening technology that presents the images to radiologists in an in-depth, three-dimensional view.  Pairs of stereo images of the breast are acquired and then viewed by combining a 3D review workstation and dedicated glasses specifically designed to present 3D breast images.  Because 3D Digital Mammography uses the similar clinical workflow as traditional FFDM, and because it presents the stereo images in a standard mammographic view of the breast (i.e., LCC, RCC, LMLO, or RMLO) that is familiar for radiologists, it has the potential to increase throughput and diagnostic confidence. The new 3D system will be especially powerful when viewing overlapping tissue, especially in dense breasts, and will enable radiologists to better visualize abnormalities. This assertion is supported by a previous study of 3D stereo digital mammography at Emory University(2) that demonstrated a 23 percent increase in sensitivity, and a 46 percent reduction in patient call backs.(3)

According to Satoshi Arakawa, Vice President of the Medical Systems Division at Fujifilm Europe, "European clinicians are expressing increased enthusiastic interest in the 3D system. Initial reports of ongoing studies in Germany indicate that the low-dose 3D FFDM system has yielded statistically significant reduction in recall rates." Arakawa continues, "These results are very encouraging. We hope to see many more clinics and patients benefit from this new 3D technology."

The global leader in digital mammography with more than 8,500 users throughout the world, Fujifilm is building upon its proven technological foundation for breast screening with its 3D Digital Mammography.  Images will be acquired with the AspireHD Plus(4) FFDM system upgraded with 3D capability(1) that will combine the use of innovative Direct Optical Switching (DOS) detector technology and Fujifilm's legacy 50-micron resolution to produce the exceptional image quality and detailed visualization that is particularly critical for interpreting mammography studies. This 50-micron resolution is the foundation for Fujifilm's entire breast imaging portfolio including its recently FDA cleared Aspire™ HD and CR-based FFDM.  Fujifilm is the first manufacturer to provide an FDA-approved CR-based FFDM system in the U.S., the scalable Aspire™ ClearView.

For more information or to see a demonstration of the product, please visit booth # 4009 at the RSNA2011, November 27th­– December 2nd at McCormick Place in Chicago, Ill. 

RSNA Booth # 4009, SOUTH BLG, HALL A

About Fujifilm

FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of diagnostic imaging products and medical informatics solutions to meet the needs of healthcare facilities today and well into the future. From an unrivaled selection of digital x-ray systems, to the Synapse® brand of PACS, RIS and cardiovascular products, to advanced women's health imaging systems, Fujifilm has products that are ideal for any size imaging environment. FUJINON is a subsidiary of FUJIFILM Medical Systems U.S.A., Inc., and supplies technologically advanced endoscopes to the medical market. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT. For more information visit www.fujimed.com.

(1) 3D Digital Mammography is a works-in-progress and is not yet commercially available for sale in the U.S.

(2) Stereoscopic Digital Mammography, 2007. C.J. D'Orsi, M.D., R.M. Pickett, Ph.D., M.S.Newell, M.D.,K.R. Gundry, M.D., S.F.Roberson, M.D., S.R.Bates, M.D. et al 

(3) Getty 2008 - Stereoscopic digital mammography - Improved accuracy of lesion detection in breast cancer screening" in IWDM 2008, LNCS 5116, pp. 74–79, 2008

(4) The Aspire™ HD Plus is known as Amulet f  in other countries. It requires FDA clearance and is not yet commercially available for sale in the U.S.

© 2011 FUJIFILM Medical Systems U.S.A., Inc.


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