Fujifilm Submits PMA Application for Breast Imaging Technology

Stamford, Conn.-based Fujifilm Medical Systems USA Inc., which makes diagnostic imaging solutions, has submitted the first module of its premarket approval (PMA) application for digital breast tomosynthesis (DBT) as an optional upgrade for the Aspire Cristalle mammography system to the U.S. Food and Drug Administration (FDA). 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.

“The rest of the world has embraced the exceptional image quality and gentle dose of Fujifilm’s digital breast tomosynthesis,” said Rob Fabrizio, director of marketing and product development. “Fujifilm is now focused on bringing this technology to the U.S. market. We are excited to move a step closer in providing another innovative alternative in digital mammography to facilities and their patients.”

Aspire Cristalle features Fujifilm’s hexagonal close pattern (HCP) detector pixel design, engineered for higher acquisition efficiency, to enhance detail for improved low dose performance compared to conventional square pixel design. The result, the company claims, is sharper images with gentler dose to the patient. Additionally, Aspire Cristalle incorporates a patient calming design and Fujifilm’s patented Comfort Paddle, designed to make the most uncomfortable part of mammograms more comfortable. The paddle’s soft edges, flexible composition and 4-way pivot contours to the individual shape of the breast to more comfortably apply just the right compression for optimal tissue separation.

According to the National Cancer Institute, 1 in 8 women will be diagnosed with breast cancer in their lifetime. The stage at which breast cancer is detected influences a woman’s chance of survival. Fujifilm’s goal is to facilitate the early detection of breast cancer through advances in digital mammography as well as supplementary screening or diagnostic testing, including breast ultrasound.