FDA Approves Fujifilm’s Digital Breast Tomosynthesis

FUJIFILM Medical Systems U.S.A. Inc., a provider of diagnostic imaging products and medical informatics solutions, 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 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 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, Nev. and the Society of Breast Imaging (SBI) Symposium, April 6-9, 2017, Los Angeles, Calif.