Technology | Mammography | January 24, 2017

FDA Approves Fujifilm's 3-D Mammography

U.S. customers now have access to optional tomosynthesis software upgrade for Aspire Cristalle full field digital mammography system

Fujifilm, Aspire Cristalle full field digital mammography system, digital breast tomosynthesis, DBT software upgrade, FDA approval

January 24, 2017 — Fujifilm Medical Systems U.S.A. Inc. announced that its Digital Breast Tomosynthesis (DBT) software upgrade for its Aspire Cristalle digital mammography system, has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). The optional DBT upgrade is now available in the United States.

Radiologists using the Aspire Cristalle full field digital mammography (FFDM) system with DBT will realize enhanced clinical efficiency compared to using FFDM alone. This includes superior diagnostic accuracy and lower recall rates for non-cancer cases, according to Fujifilm.

Known as Amulet Innovality outside of the United States, the optional DBT upgrade has been widely available in Europe, Asia and Latin America since May 2013. The Aspire Cristalle FFDM system with DBT combines Fujifilm’s hexagonal close pattern (HCP) detector design, advanced image processing and image acquisition workflow to optimize patient dose while maximizing image quality.

With the DBT software option, the X-ray tube moves through an arc around the breast, acquiring a series of low-dose image slices at different angles, producing a three-dimensional view allowing radiologists to see through tissue less obstructed. The acquired images are reconstructed into a series of high-resolution 1 millimeter slices displayed individually or dynamically in a cine mode — making it easier to identify lesions that might be difficult to see in traditional 2-D mammography images due to overlapping breast structures. This will bring a new level of diagnostic confidence in screening, and especially for those women with dense breast tissue who are at higher than average risk and more difficult to screen with traditional 2-D only.

The Aspire Cristalle FFDM system with DBT will be on display at the National Consortium of Breast Centers (NCoBC) conference, March 11-13, 2017 in Las Vegas, and the Society of Breast Imaging (SBI) Symposium, April 6-9, 2017, in Los Angeles.

For more information: www.fujimed.com

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Images in a 55-year-old screening participant. (a, b) Normal digital full-field mediolateral oblique (a) and craniocaudal (b) mammograms (BI-RADS category 1) show a heterogeneously dense breast (ACR category C). (c) Screening ultrasound image shows normal findings (BI-RADS category 1). (d) MR-guided biopsy enabled us to confirm the presence of an invasive high-grade triple-negative cancer (no special type [NST], pT1b, N0, M0). (d) Breast MR image shows a suspicious enhancing mass (arrow) in the left breast (BI-RADS category 5). Image courtesy of the Radiological Society of North America.

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