FDA approves Fujifilm's digital breast tomosynthesis option for Aspire Cristalle Digital Mammography System: 3 key facts

Stamford, Conn.-based Fujifilm Medical Systems USA received FDA premarket approval for its Digital Breast Tomosynthesis software.

The approval allows for the release of an optional upgrade to the Aspire Cristalle digital mammography system.

Here's what you should know.

1. The upgrade increases the machine's diagnostic accuracy while also lowering recall rates for non-cancer cases.

2. The option upgrade is now available in the United States. It has been widely in available across Europe, Asia and Latin America since May 2013.

3. Rob Fabrizio, director of strategic marketing, digital radiography and women’s health at FUJIFILM Medical Systems U.S.A, said, "Receiving FDA approval for DBT is a momentous occasion for Fujifilm. The unique dose savings and patient comfort innovations already available in the ASPIRE Cristalle FFDM system are now coupled with the new 3-D imaging capabilities - an exciting advancement that U.S. providers have long been waiting for in their fight for early detection of breast cancer."

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