Technology | Mammography | January 24, 2017

FDA Approves Fujifilm's 3-D Mammography

U.S. customers now have access to optional tomosynthesis software upgrade for Aspire Cristalle full field digital mammography system

Fujifilm, Aspire Cristalle full field digital mammography system, digital breast tomosynthesis, DBT software upgrade, FDA approval

January 24, 2017 — Fujifilm Medical Systems U.S.A. Inc. announced that its Digital Breast Tomosynthesis (DBT) 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 is now available in the United States.

Radiologists using the Aspire Cristalle full field digital mammography (FFDM) system with DBT will realize enhanced clinical efficiency compared to using FFDM alone. This includes superior diagnostic accuracy and lower recall rates for non-cancer cases, according to Fujifilm.

Known as Amulet Innovality outside of the United States, the 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 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 radiologists 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 2-D 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 2-D only.

The Aspire Cristalle FFDM system with DBT will be on display at the National Consortium of Breast Centers (NCoBC) conference, March 11-13, 2017 in Las Vegas, and the Society of Breast Imaging (SBI) Symposium, April 6-9, 2017, in Los Angeles.

For more information: www.fujimed.com

Related Content

ABUS: An Important Companion to Traditional Mammography

The multi-use ultrasound breast system Acuson S2000 Automated Breast Volume Scanner (ABVS) from Siemens Healthineers automatically acquires volume images of the breast. Photo courtesy of Siemens.

Feature | Ultrasound Women's Health | April 18, 2018 | Emily Clemons
Research shows that automated br...
DenseBreast-info.org Celebrates Third Anniversary
News | Breast Density | April 17, 2018
April 2018 marks the third anniversary of the launch of DenseBreast-info.org, the educational resource for medically...
Technology | Breast Density | April 13, 2018
Densitas Inc. has received U.S. Food and Drug Administration (FDA) clearance for its DENSITAS|density automated breast...
Volpara Solutions and Mammography Educators Launch Mammography Positioning Training Videos
News | Mammography | April 12, 2018
Volpara Solutions Inc. and mammography education provider Mammography Educators LLC announced the launch of training...
Ikonopedia Introduces Enhanced Breast Ultrasound Reporting Module at SBI
News | Ultrasound Women's Health | April 11, 2018
Ikonopedia will introduce its next-generation breast ultrasound reporting module at the 2018 Society for Breast Imaging...
ACR/SBI Breast Cancer Screening Guidelines Reclassify African-American Women as High-Risk
News | Breast Imaging | April 06, 2018
New American College of Radiology (ACR) and Society of Breast Imaging (SBI) breast cancer screening guidelines are the...
News | Oncology Diagnostics | April 05, 2018
April 5, 2018 — Myriad Genetic Laboratories Inc.
Wisconsin Gov. Walker Signs Breast Density Reporting Bill
News | Breast Density | April 05, 2018 | Jeff Zagoudis, Associate Editor
Wisconsin Gov. Scott Walker made the Badger State the 35th state to report dense breast tissue to patients as part of...
Diagnosing Breast Cancer Using Red Light

Schematic diagram for OM instrument: Seven pulsed lasers sequentially illuminate the compressed breast; transmitted light is detected by the 8-channel SiPM probe and the TDC acquires the signal. Credit: Edoardo Ferocino

News | Breast Imaging | April 02, 2018
Optical mammography (OM), which uses harmless red or infrared light, has been developed for use in conjunction with X-...
ACR Recommends More Aggressive Breast Cancer Screening for Higher-Than-Average-Risk Women
News | Breast Imaging | March 29, 2018
The American College of Radiology (ACR) released new breast cancer screening guidelines recommending all women,...
Overlay Init