FDA Approves FUJIFILM's Digital Breast Tomosynthesis Option for ASPIRE Cristalle Digital Mammography System

STAMFORD, Conn.--(BUSINESS WIRE)--

FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging products and medical informatics solutions, today announced that its Digital Breast Tomosynthesis (DBT), as an optional software upgrade for its ASPIRE Cristalle digital mammography system, has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). The optional DBT upgrade for the ASPIRE Cristalle system is now available in the United States.

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"Receiving FDA approval for DBT is a momentous occasion for Fujifilm," said Rob Fabrizio, Director of Strategic Marketing, Digital Radiography and Women's Health, FUJIFILM Medical Systems U.S.A., Inc. "The unique dose savings and patient comfort innovations already available in the ASPIRE Cristalle FFDM system are now coupled with the new 3D imaging capabilities - an exciting advancement that U.S. providers have long been waiting for in their fight for early detection of breast cancer."

Radiologists using the ASPIRE Cristalle FFDM system with DBT will realize valuable enhanced clinical efficiency compared to using FFDM alone, this includes superior diagnostic accuracy and lower recall rates for non-cancer cases.

Known as AMULET Innovality outside of the United States, Fujifilm's optional DBT upgrade has been widely available in Europe, Asia and Latin America since May 2013. The ASPIRE Cristalle FFDM system with DBT combines Fujifilm's state-of-the-art hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow to optimize patient dose while maximizing image quality.

With the DBT software option, the x-ray tube moves through an arc around the breast, acquiring a series of low-dose image slices at different angles, producing a three-dimensional view allowing radiologist to see through tissue less obstructed. The acquired images are reconstructed into a series of high-resolution 1 millimeter slices displayed individually or dynamically in a cine mode—making it easier to identify lesions that might be difficult to see in traditional 2D mammography images due to overlapping breast structures. This will bring a new level of diagnostic confidence in screening, and especially for those women with dense breast tissue who are at higher than average risk and more difficult to screen with traditional 2D only.

Fujifilm's ASPIRE Cristalle FFDM system with DBT will be on display at the National Consortium of Breast Centers (NCoBC) conference from March 11-13, 2017 in Las Vegas, NV and the Society of Breast Imaging (SBI) Symposium, April 6-9, 2017, Los Angeles, CA. For more information about Fujifilm, please visit 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. The Endoscopy Division of FUJIFILM Medical Systems U.S.A., Inc. supplies high quality, technologically advanced FUJINON brand endoscopes to the medical market. TeraMedica Division delivers healthcare informatics, and is the leading provider of vendor neutral, enterprise-wide solutions for unrestricted medical image management. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT. For more information please visit www.fujifilmhealthcare.com and www.fujifilmendoscopy.com.

FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. In the year ended March 31, 2016, the company had global revenues of $22.1 billion, at an exchange rate of 112.54 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.

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