The US Food and Drug Administration (FDA) has received the first module from Fujifilm Medical Systems for premarket approval (PMA) application for its digital breast tomosynthesis (DBT), as an optional upgrade for the Aspire Cristalle mammography system.
The company submitted the first module for FDA PMA modular review and plans to file the remaining modules of DBT PMA in 2016.
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Known as Amulet Innovality outside of the US, the optional DBT upgrade for the Aspire Cristalle system has been available in Europe, Asia and Latin America since May 2013.
Fujifilm Medical Systems US marketing and product development director Rob Fabrizio said: "The rest of the world has embraced the exceptional image quality and gentle dose of Fujifilm’s digital breast tomosynthesis.
"Fujifilm is now focused on bringing this technology to the US market.
"We are excited to move a step closer in providing another innovative alternative in digital mammography to facilities and their patients."
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By GlobalDataAspire Cristalle features Fujifilm’s innovative hexagonal close pattern detector pixel design to help enhance detail for improved low dose performance compared to legacy square pixel design, resulting in sharper images with a gentler dose to the patient.
In addition, a patient calming design and Fujifilm’s patented Comfort Paddle have been incorporated into the system 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 more comfortably apply the right compression for optimal tissue separation.
Fujifilm continues to conduct research and work with specialists in the field to develop revolutionary and reliable imaging technologies for breast cancer, which according to the National Cancer Institute, will affect one in eight women in their lifetime.
The company’s Fujifilm’s full field digital mammography solutions are trusted by more than 1,900 facilities worldwide.
Image: The Aspire Cristalle system has been available in Europe, Asia and Latin America since May 2013. Photo: courtesy of Business Wire.
