Diagnostic Imaging Solutions Provider Submits Mammography Upgrade for FDA Approval

A leading provider of medical informatics solutions and diagnostic imaging products has submitted the first of several modules of its Digital Breast Tomosynthesis (DBT) upgrade for its mammography system, for Pre-Market Approval (PMA), to the US Food and Drug Administration (FDA).

The optional upgrade has already been available in Europe, Latin America, and Asia since May, 2013, and features a Hexagonal Close Pattern (HCP) detector design, with higher acquisition efficiency, enabling improved low dose performance compared to conventional detector designs. The mammography system also includes a paddle with four-way pivot contours to fit the different breast shapes and enable more gentle application of compression of the breast for optimal tissue separation with minimal patient discomfort.

The Digital Breast Tomosynthesis (DBT) upgrade, known as Amulet Innovality outside of the United States, was designed and developed by FUJIFILM Medical Systems USA (Stamford, CT, USA) and is intended for the FUJIFILM Aspire Cristalle full-field digital Computed Radiography (CR) mammography system.

One in 8 women in the US is diagnosed with breast cancer in their lifetime, and early detection is crucial for a woman’s chance of survival. Fujifilm also provides breast ultrasound imaging systems.

Rob Fabrizio, FUJIFILM Medical Systems USA, 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 US market. We are excited to move a step closer in providing another innovative alternative in digital mammography to facilities and their patients.”

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