Welcome!

News Feed Item

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.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"We are the public cloud providers. We are currently providing 50% of the resources they need for doing e-commerce business in China and we are hosting about 60% of mobile gaming in China," explained Yi Zheng, CPO and VP of Engineering at CDS Global Cloud, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, discussed using predictive analytics to mon...
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...