Fujifilm to Begin Clinical Trials of 3D Mammography

Chicago, IL - November 28, 2010 - The next potential mainstay for breast screening, 3Dimensinal Digital Mammography¹, has taken a step closer to commercialization. Today at the Radiological Society of North America (RSNA) Annual Meeting, FUJIFILM Medical Systems U.S.A, Inc. announced that clinical trials have begun in Japan, where researchers are currently acquiring 3D Digital Mammography studies for review. In early 2011 the technology is set to start clinical evaluations at breast screening facilities across the United States, beginning with Emory University, Atlanta, Georgia.

3Dimensional Digital Mammography is an innovative breast screening technology that presents the images to the radiographer in an in-depth, three-dimensional view. A pair of stereo images of the breast are acquired and then viewed by combining a workstation and dedicated glasses specifically designed to present a single, instantly available, 3D breast image. Because 3D Digital Mammography uses the same workflow as traditional Full Field Digital Mammography (FFDM), and because it presents the images in a view of the breast that is familiar for radiologists, it is expected to increase throughput and diagnostic confidence. This assertion is supported by a previous study of 3D digital mammography at Emory University2 that demonstrated a 23 percent increase in specificity, and a 47 percent reduction in patient call backs.

“Fujifilm is committed to continually innovating our breast screening technologies to provide the most powerful tools possible for the early detection of breast cancer,” says David Hotchkiss, Director of Modality Solutions Marketing at Fujifilm. “We have thoroughly evaluated the needs of patients and clinicians, as well as the benefits and limitations of current technologies. We believe that when approved, 3Dimensional Digital Mammography will be the screening technology of choice, elevating diagnostic confidence, enhancing workflow, and improving patient care.”

The global leader in digital mammography with more than 8000 users throughout the world, Fujifilm is building upon its proven technological foundation for breast screening with its 3Dimensional Digital Mammography. Images will be acquired with the AspireHD3 FFDM system that will combine the use of innovative Direct Optical Switching (DOS) 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 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 about Fujifilm’s advanced 3Dimensional Digital Mammography, visit RSNA booth #5600 or www.fujimed.com.

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.

¹ 3Dimensional Digital Mammography requires FDA approval 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 The Aspire HD requires FDA approval and is not yet commercially available for sale in the U.S. The Aspire HD is marketed as the Amulet outside the U.S.

Last changed: 12/16/2010 at 12:38 PM