Fujifilm Holdings (TSE:4901) said yesterday it filed a 2nd pre market approval module for a digital breast tomosynthesis upgrade for its Aspire Cristalle mammography system.
The company expects to submit the remaining modules for the DBT upgrade, known as Amulet Innovality outside of the U.S., within the coming year.
“Digital breast tomosynthesis technology is making a positive difference for women and clinicians around the world. This recent submission is a significant step toward launching our innovative solution here in the U.S. We’re proud to announce this latest move forward in our goal to support better breast cancer detection and diagnosis with DBT technology that delivers high quality images at a low dose,” digital x-ray and women’s health 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.
Fujifilm submitted the 1st module in July.
