STAMFORD, Conn.--(BUSINESS WIRE)--FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging solutions, has submitted to the U.S. Food and Drug Administration (FDA) the first module of its premarket approval (PMA) application for digital breast tomosynthesis* (DBT), as an optional upgrade for the Aspire Cristalle mammography system. It is the first module submitted for FDA PMA modular review. Fujifilm plans to file the remaining modules of DBT PMA within the coming year.
The optional DBT upgrade for the Aspire Cristalle system, known as Amulet Innovality outside of the United States, has been available since May 2013 in Europe, Asia and Latin America.
“The rest of the world has embraced the exceptional image quality and gentle dose of Fujifilm’s digital breast tomosynthesis. Fujifilm is now focused on bringing this technology to the U.S. market,” said Rob Fabrizio, director of marketing and product development, FUJIFILM Medical Systems U.S.A., Inc. “We are excited to move a step closer in providing another innovative alternative in digital mammography to facilities and their patients.”
Aspire Cristalle features Fujifilm's innovative hexagonal close pattern (HCP) detector pixel design, engineered for higher acquisition efficiency, to enhance detail for improved low dose performance compared to conventional square pixel design. The result is sharper images with gentler dose to the patient. Additionally, Aspire Cristalle incorporates a patient calming design and Fujifilm’s patented Comfort Paddle which is designed to make the most uncomfortable part of mammograms, more comfortable. The paddle’s unique soft edges, flexible composition and 4-way pivot contours to the individual shape of the breast to more comfortably apply just the right compression for optimal tissue separation.
According to the National Cancer Institute, 1 in 8 women will be diagnosed with breast cancer in their lifetime. The stage at which breast cancer is detected influences a woman’s chance of survival. Fujifilm is dedicated to promoting the early detection of breast cancer through advances in digital mammography as well as supplementary screening or diagnostic testing, including breast ultrasound. Fujifilm continues to conduct research and collaborate with specialists in the field to develop revolutionary and reliable imaging technologies. Over 1,900 facilities worldwide trust Fujifilm's full field digital mammography solutions, and over 9,000 including CR mammography, making Fujifilm the most popular digital mammography system provider in the world.
For more information, please visit: www.fujimed.com.
* Caution - DBT option is an investigational device, limited by Federal Law to investigational use.
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. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT. For more information please visit www.fujimed.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, 2015, the company had global revenues of $20.8 billion, at an exchange rate of 120 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.
