Fujifilm Medical Systems USA has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for digital breast tomosynthesis (DBT).
The optional DBT upgrade for its Aspire Cristalle mammography system is the first module submitted for FDA PMA module review, according to the company. Fujifilm said it plans to file the remaining modules of the DBT PMA within the coming year.
The upgrade has been available since May 2013 in Europe, Asia, and Latin America. Aspire Cristalle is known as Amulet Innovality outside of the U.S.
