FDA Approves FUJIFILM’s Digital Breast Tomosynthesis Option for ASPIRE Cristalle Digital Mammography System
STAMFORD, Conn.–(BUSINESS WIRE)–#breastcancer—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.
“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.
All product and company names herein may be trademarks of their
registered owners.
Contacts
Fujifilm
Lauren Geloso, 914-789-8303
lgeloso@fujifilm.com
