July 16, 2015 - Fujifilm Medical Systems U.S.A. Inc. 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). The module will be offered 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.
Aspire Cristalle features Fujifilm's hexagonal close pattern (HCP) detector pixel design, engineered for higher acquisition efficiency and 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 soft edges, flexible composition and four-way pivot contour to the individual shape of the breast to more comfortably apply just the right compression for optimal tissue separation.
For more information: www.fujimed.com