Fujifilm Medical Systems (TSE:4901) said today it submitted the 1st module of its FDA premarket approval application for digital breast tomosynthesis as an upgrade for its Aspire Cristalle mammography system.
The module is the 1st to be submitted for FDA PMA modular review with plans to submit the remaining modules within the coming year, Stamford, Conn.-based Fujifilm Medical Systems 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 U.S. market. We are excited to move a step closer in providing another innovative alternative in digital mammography to facilities and their patients,” Fujifilm Medical Systems director of marketing and product development Rob Fabrizio said in a press release.
The company’s system features hexagonal close pattern detector pixel design, intended to improve image quality, Fujifilm said.
The device is also designed to be more comfortable for mammography patients, requiring lower doses for imaging and integrating soft edges and 4-way pivoting to contour to to different body shapes.
The digital breast tomosynthesis system has been available since 2013 in Europe, Asia and Latin America, Fujifilm said.