Fujifilm gets FDA premarket approval for Digital Breast Tomosynthesis

24 January 2017 (Last Updated January 24th, 2017 18:30)

Fujifilm Medical Systems USA has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Digital Breast Tomosynthesis (DBT) option of ASPIRE Cristalle system.

Fujifilm gets FDA premarket approval for Digital Breast Tomosynthesis

Fujifilm Medical Systems USA has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Digital Breast Tomosynthesis (DBT) option of ASPIRE Cristalle system.

DBT has been developed as an optional software upgrade for the digital mammography ASPIRE Cristalle FFDM system.

Designed to optimise patient dose and improve image quality, the ASPIRE Cristalle FFDM system with DBT utilises a combination of hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow.

The software option enables the x-ray tube to move in an arc around the breast, obtain a series of low-dose image slices at different angles and generate a three-dimensional view.

Fujifilm Medical Systems Strategic Marketing, Digital Radiography and Women’s Health director Rob Fabrizio said: “The unique dose savings and patient comfort innovations already available in the ASPIRE Cristalle FFDM system are now coupled with the new 3D imaging capabilities, an exciting advancement that US providers have long been waiting for in their fight for early detection of breast cancer.”

"The software option enables the x-ray tube to move in an arc around the breast, obtain a series of low-dose image slices at different angles and generate a three-dimensional view."

The images obtained through the device are reconstructed into a series of high-resolution 1mm slices and are displayed individually or dynamically in a cine mode, which avoids overlapping breast structures and helps in easy detection of lesions.

The combination of ASPIRE Cristalle FFDM system with DBT is expected to offer diagnostic accuracy and decrease the recall rates for non-cancer cases.

Available in Europe, Asia and Latin America since May 2013, the DBT upgrade option will now be accessible for use across the US.


Image: Fujifilm ASPIRE Cristalle mammography system. Photo: courtesy of Fujifilm.