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> FDA Approves FUJIFILM’s Digital Breast Tomosynthesis Option

Breast cancer screening using tomosynthesis in combination with digital mammography.

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FDA Approves FUJIFILM’s Digital Breast Tomosynthesis ..

Finding the Role for Digital Breast Tomosynthesis
By Kathy Hardy
Radiology Today
Vol. 12 No. 11 P. 32

digital breast tomosynthesis fda approval

Conant is a fellow of the Society of Breast Imaging and a member of a multitude of professional organizations, including the American Roentgen Ray Society, National Association of University Radiologists, International Digital Mammography Development Group, and the Radiological Society of North America.

“Off Label” Use of FDA-Approved Devices and Digital Breast ..

Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening.

“Two years ago, there was a lot of skepticism about tomosynthesis,” Destounis says. “There were questions about where this would fit in to the breast screening and diagnosis process. It was seen as expensive, with no reimbursement and an increase in radiation.”

Destounis presented research findings at the American Roentgen Ray Society’s annual meeting earlier this year showing that DBT is comparable to or better than conventional digital breast mammography at identifying microcalcifications in up to 95% of cases. Elizabeth Wende was one of the sites that collected data while using Hologic’s Dimensions system.

(FDA) approval with respect to Digital Breast ..

Devices and Digital Breast Tomosynthesis.

A US cost-effectiveness analysis43 of biennial screening of women aged 50 to 74 with dense breasts calculated an incremental cost per life-year gained of US$70,500 for 2D plus 3D screening versus 2D alone. Clinical data were obtained from the Norwegian trial36 and the base case cost of additional DBT was set at US$50 (US data were not available at the time of the analysis). The calculated incremental cost per quality-adjusted life-year (QALY) was about US$54,000 (neither cost per cancer detected nor impact on mortality rates were reported). Assuming that DBT led to moderate improvements in sensitivity and specificity, 405 false-positive results were avoided per 1,000 women after 12 screening rounds and 0.5 breast cancer-related deaths per 1,000 women were averted. The cost-effectiveness was most sensitive to the additional cost of tomosynthesis; increasing the cost of adjunct tomosynthesis did not affect the relative cost-effectiveness of combined screening until the added cost of tomosynthesis exceeded US$87, for a total screening cost of US$226.43

Conant has received grants from the National Institutes of Health to compare standard surgical biopsy with digital mammography and stereotactic core breast biopsy.

27/09/2010 · FDA panel votes in favour of Hologic's digital breast tomosynthesis
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Digital Breast Tomosynthesis - Scribd

Food and Drug Administration (FDA) approval with respect to Digital Breast Tomosynthesis (DBT).DBT is a major improvement over 2D mammography in the detection of cancers (sensitivity) and the reduction in recalls resulting from screening (specificity).

Digital Breast Tomosynthesis ..

Comparision between two-dimensional synthetic mammography reconstructed from digital breast tomosynthesis and full-field digital mammography for the detection of T1 breast cancer.

25/01/2016 · Digital breast tomosynthesis ..

Traditional two-dimensional (2D) mammography captures two static images of the breast. One particular shortcoming of 2D technology is the overlapping of breast images that can decrease accuracy of interpretation. With digital breast tomosynthesis (DBT), an X-ray beam sweeps in an arc of 15 to 50 degrees (depending on the manufacturer) across the breast, and an electronic detector digitally captures between nine and 25 X-ray projection images.1-6 These images are generally captured in two views: craniocaudal (head-to-toe direction) and mediolateral oblique (angled side-view).2,3,5 The data from these projections are used in computer algorithms to reconstruct a series of parallel thin "slices" (tomographic images) corresponding to 0.5 mm to 1 mm intervals through the breast. The slices create a three-dimensional (3D) volume of data that represents the breast's tissue structures.

Digital Breast Tomosynthesis - 2nd generation DBT

To perform tomosynthesis, the detector must acquire high-resolution images at a relatively high speed while maintaining good imaging performance at a low dose per image. When it comes to the length of an exam, Hologic says the DBT process takes only seconds longer than a conventional 2D digital mammogram, and the total exam dose is within current FDA guidelines. The image acquisition time is approximately 15 to 20 seconds, and the radiation dose is only 1 to 1.5 times the radiation normally given in a standard screening mammogram.

CARESTREAM Vue Mammo Workstation Digital Breast Tomosynthesis …

"Receiving FDA approval for DBT is a momentous occasion for Fujifilm," said Rob Fabrizio, Director of Strategic Marketing, Digital Radiography and Women's Health, FUJIFILM Medical Systems U.S.A., Inc. "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 U.S. providers have long been waiting for in their fight for early detection of breast cancer."

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