Fujifilm Holdings (TSE:4901) said yesterday it filed its last Premarket Approval module to the FDA for its Aspire Cristalle breast tomosynthesis optional software upgrade for its Aspire Cristalle digital mammography system.
The optional upgrade is known as the Amulet Innovality outside of the U.S., and has been available since May 2013 in the E.U., Asia and Latin America, the company said.
“Today marks another milestone in Fujifilm’s mission to bring innovative digital breast tomosynthesis technology to physicians and women across America,” digital radiography & women’s health director of strategic marketing 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 company submitted its 2nd module last November, and the 1st module last July.
The post Fujifilm files last PMA module for Aspire Cristalle breast tomosynthesis software appeared first on MassDevice.
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