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FUJIFILM Announces FDA 510(k) Clearance for New Breast Imaging Solution: Aspire Cristalle

FUJIFILM Medical Systems U.S.A., Inc., a global leader in technology innovation with the largest worldwide install base of digital mammography systems, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the Aspire Cristalle. The Aspire Cristalle resets the bar in digital mammography, combining innovative detector engineering with well thought out patient focused ergonomics, resulting in faster more confident diagnosis for clinicians and exceptional patient comfort. First commercialized in Asia and Europe, the Aspire Cristalle has taken hold of our customers' imagination and challenged the status quo in breast imaging technology across the globe.

“Aspire Cristalle nicely represents our latest culmination of imaging innovation and attention to every detail in design,” said Rob Fabrizio, director of marketing and product development, Digital x-ray and Women’s Health, FUJIFILM Medical Systems U.S.A., Inc. “The Aspire Cristalle will deliver brilliant images with gentle dose, while redefining the patient experience through a notably more comfortable exam.”

The Aspire Cristalle brings an innovative solution to breast imaging customers around the world. New advancements include:

  • Patient Experience enhancements such as our patented Comfort Paddle, are 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 compression for optimal tissue separation. The system also features new patient grip handles and padding for added stability and comfort, even soft backlighting and graphic mural decals to help ease patient anxiety and improved access for wheelchair exams, just to name a few.
  • Hexagonal Close Pattern (HCP) is an innovative detector pixel design, engineered to deliver higher acquisition efficiency, for finer detail, higher DQE, higher MTF and lower dose than conventional square pixel arrays. Engineered to produce brilliant images at low dose.
  • The system’s image quality is further enhanced with Fujifilm’s renowned image processing, iAEC automated exposure controls and ISC precisely tuned contrast, to intelligently adapt to the specific characteristics for every breast type and to image implants with ease.

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 9,000 worldwide facilities trust Fujifilm's full field digital mammography solutions, making Fujifilm the most popular digital mammography system provider in the world. For more information, please visit: aspire.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. 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, 2014, the company had global revenues of $23.7 billion, at an exchange rate of 103 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.

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