FUJIFILM Medical Systems USA Inc has submitted to FDA the first module of its premarket approval (PMA) application for digital breast tomosynthesis (DBT) 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.
“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 at FUJIFILM. “We are excited to move a step closer in providing another innovative alternative in digital mammography to facilities and their patients.”
Engineered for higher acquisition efficiency, Aspire Cristalle features Fujifilm’s hexagonal close pattern detector pixel design 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 mammograms more comfortable. The paddle’s soft edges, flexible composition, and four-way pivot contours to the individual shape of the breast to apply the right compression for optimal tissue separation.
For more information, visit FUJIFILM.
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