Technology | April 23, 2015

FDA Clears Siemens Breast Tomosynthesis Mammography System

Tomosynthesis option shown to increase diagnostic accuracy in screening mammography; boasts wide-angle tomosynthesis of up to 50 degrees

Mammomat inspiration with tomosynthesis, 3D mammography

April 23, 2015 — The U.S. Food and Drug Administration (FDA) has approved Siemens Healthcare’s 3-D mammography, breast tomosynthesis imaging system. This marks the 3-D mammography vendor to enter the U.S. market. 

Siemens’ Mammomat Inspiration with Tomosynthesis Option is a breast tomosynthesis add-on option for Siemens Mammomat Inspiration digital mammography platform. Siemens’ breast tomosynthesis algorithm reconstructs multiple 2-D images of the breast into an approximation of a 3-D image to enable detection of tumors that are hidden by overlapping breast tissue, enabling more accurate diagnosis than standard 2-D digital mammography and reducing the number of false-positive findings. In a recent study involving 22 readers with a broad range of reading experience, Siemens demonstrated that all readers improved their accuracy in detecting and diagnosing cancers when reading digital breast tomosynthesis as an adjunct to full-field digital mammography.

In tomosynthesis mode, the X-ray tube of the Mammomat Inspiration digital mammography system rotates in a circular motion around the breast to acquire an image every two degrees while moving through an angular range of 50 degrees. The resulting 25 projections are reconstructed as three-dimensional  digital breast tomosynthesis (DBT) images.
 
Conventional analog mammography and full-field digital mammography display only the 3-D structure of the breast on a 2-D level, hampering physicians’ efforts to identify certain types of tumors since anatomical structures in the breast can overlap and obscure lesions. Tomosynthesis acquires several breast projections from different angles and uses raw data to generate a 3-D volume dataset. Using this data set, clinicians can better analyze the type and size of breast lesions as well as microcalcifications compared to other forms of mammography. Breast tomosynthesis increases mammography’s sensitivity and specificity, in addition to improving efforts to differentiate and classify breast tumors.
 
“Our clinical data has demonstrated that the addition of Siemens’ digital breast tomosynthesis to a patient’s traditional 2-D digital mammogram increases detection of breast tumors. We know that in clinical practice, this increased diagnostic accuracy also means fewer diagnostic biopsy procedures and fewer anxiety-inducing recalls, which typically contributes to both improved patient outcomes and reduced cost,” said Gregory Sorensen, M.D., president and CEO of Siemens Healthcare North America. “With the FDA approval of the Mammomat Inspiration with Tomosynthesis Option, Siemens Healthcare reaffirms its longstanding commitment to cutting-edge innovation in women’s health.”
 
The Mammomat Inspiration with Tomosynthesis Option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia, and South America. The4 new breast tomosynthesis option is available on the company’s Mammomat Inspiration and Mammomat Inspiration Prime Edition digital mammography systems.
 
For more information: www.siemens.com

Related Content

Category A

Category A

Feature | Breast Density | April 03, 2020 | By Dayna Williams M.D., Shivani Chaudhry, M.D., and Laurie R. Margolies, M.D.
Breast cancer is the most common cance
#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2
News | Mammography | March 25, 2020
March 25, 2020 — The...
The 2020 Society of Breast Imaging/American College of Radiology (SBI/ACR) annual symposium has been cancelled, and the event rescheduled for April 8-11, 2020, in Savannah, Ga. #COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SBI20
News | Society of Breast Imaging (SBI) | March 16, 2020
March 16, 2020 — The 2020 Society of Breast Imaging/American College of Radiology (...
DBT, sometimes called 3-D mammography, emerged in the last decade as a powerful tool for breast cancer screening

Images in a 57-year-old woman noted to have "good prognosis" invasive cancer detected at digital breast tomosynthesis (DBT) screening. (a) Craniocaudal view of the left breast obtained with the two-dimensional digital mammography (DM) portion of the DM/DBT screening study demonstrates a subtle area of distortion in the medial left breast. (b) Single-slice image from the left craniocaudal DBT portion of the screening study shows an area of bridging distortion (circle). (c) Electronically enlarged image of the area of concern seen on the left craniocaudal view in a single DBT slice as shown in b. (d) Targeted US scan demonstrates two small adjacent irregular solid masses. US-guided core biopsy yielded an invasive carcinoma of the tubular subtype that was estrogen receptor positive, progesterone receptor positive, and human epidermal growth factor receptor 2 negative. The results of the sentinel node biopsy were negative. Image courtesy of the Radiological Society of North America

News | Breast Imaging | March 11, 2020
March 11, 2020 — A new study published in the journal ...
SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories

Example: SoftVue image stacks of sound speed, as shown for cases ranging across the four Breast Imaging Reporting and Data System (BI-RADS) breast density categories ((a), fatty; (b), scattered; (c), heterogeneously dense; (d), extremely dense). Note the quantitative scale indicating that absolute measurements are obtained. Image courtesy of MDPI

News | Breast Imaging | March 10, 2020
March 10, 2020 — ...
The study concludes that a combination of Artificial Intelligence algorithms and the interpretations of radiologists could, in the U.S. alone, result in a half million women not having to undergo unnecessary diagnostic tests every year

Researchers who participated in the DM (digital mammography) DREAM Challenge.

News | Mammography | March 07, 2020
March 7, 2020 — The stu...
Christopher Comstock, M.D., ECOG-ACRIN Cancer Research Group study published in JAMA builds evidence for use of abbreviated MRI in women with dense breasts

Christopher Comstock, M.D., (Memorial Sloan Kettering Cancer Center) is the lead author of a paper in JAMA that reports that abbreviated breast MRI detected significantly more (almost 2 and a half times as many) breast cancers than digital breast tomosynthesis (3-D mammography) in average-risk women with dense breasts. Photo courtesy of Memorial Sloan Kettering Cancer Center

News | Breast Imaging | February 26, 2020
February 26, 2020 — According to a study
Women 75-plus May Not Benefit from Breast Cancer Screening
News | Mammography | February 25, 2020
February 25, 2020 — According to newly published research in an article titled...
Recognized as the “Pulitzer Prize of the business press,” the Jesse H. Neal Award finalists are selected for exhibiting journalistic enterprise, service to the industry and editorial craftsmanship
News | Radiology Business | February 19, 2020
February 19, 2020 — Connectiv, a division of The Software and Information Industry Association (SIIA), has announced