Home Fairfield Fujifilm Medical Systems receives FDA approval for mammography software

Fujifilm Medical Systems receives FDA approval for mammography software

Stamford-based Fujifilm Medical Systems U.S.A. Inc., a provider of diagnostic imaging products and medical informatics solutions, has announced that its Digital Breast Tomosynthesis software has received premarket approval from the U.S. Food and Drug Administration. Digital Breast Tomosynthesis is an optional software upgrade for Fujifilm’s Aspire Cristalle digital mammography system, which is already available in the United States.

Radiologists using the Aspire Cristalle Full Field Digital Mammography system with DBT “will realize valuable enhanced clinical efficiency compared to using FFDM alone, (including) superior diagnostic accuracy and lower recall rates for non-cancer cases,” according to a Fujifilm statement.

With the Digital Breast Tomosynthesis software option, an X-ray tube moves through an arc around the breast, acquiring a series of low-dose image slices at different angles and producing a three-dimensional view that allows radiologists to see through tissue less obstructed – an improvement over traditional 2-D mammography, according to the firm.

Known as Amulet Innovality outside of the U.S., Fujifilm’s optional DBT upgrade has been widely available in Europe, Asia and Latin America since May 2013.


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