FUJIFILM Medical Systems U.S.A. Inc. has received premarket approval from the FDA for an optional digital breast tomosynthesis software upgrade for its ASPIRE Cristalle full-field digital mammography system.

Digital breast tomosynthesis has been shown to be an advance over digital mammography due to its higher cancer detection rate and lower patient recall rate, according to the American College of Radiology. Experts told HCB News that it may become the new standard for breast cancer screening.

With the DBT option, the X-ray tube on the ASPIRE Cristalle FFDM system moves through an arc around the breast to acquire a series of low-dose image slices at different angles. That generates a 3-D view of the breast, which allows the radiologist to see through the tissue without any obstruction.

The images are reconstructed into high-resolution one-millimeter slices that are displayed individually or dynamically in a cine mode. That makes it easier for radiology to spot lesions that may be hard to see on 2-D mammography images because of overlapping breast structures.

The DBT software has been widely available in Europe, Asia and Latin America under the name AMULET Innovality since May 2013. It’s now commercially available in the U.S. as well.

GE Healthcare, Siemens Healthineers and Hologic Inc. are currently the top three players in the global DBT market. They collectively account for almost 90 percent revenue share of the market, according to a Future Market Insights report from 2016.

Fujifilm’s ASPIRE Cristalle FFDM system with DBT will be on display at the National Consortium of Breast Centers conference in Las Vegas from March 11 to 13, and the Society of Breast Imaging Symposium in Los Angeles from April 6 to 9.

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