Technology | Mammography | March 28, 2018

FDA Approves New Imaging Features on Hologic 3Dimensions Mammography System

High-resolution 3-D imaging and Intelligent 2-D imaging technology now approved on Hologic’s latest digital breast tomosynthesis system

FDA Approves New Imaging Features on Hologic 3Dimensions Mammography System

March 28, 2018 — Hologic Inc. announced that Clarity HD high-resolution 3-D imaging and Intelligent 2-D imaging technology have received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) and are now available on the 3Dimensions breast tomosynthesis system. With these innovations, the system now provides higher resolution 3-D breast images for radiologists, enhanced workflow for technologists, and a more comfortable mammography experience with low-dose options for patients.

Hologic originally released the Genius 3-D Mammography exam, first approved by the FDA in 2011 on the company's 3-D Mammography system. Today, Hologic has installed more than 5,000 3-D Mammography systems throughout the United States and is continuing to help ensure insurance coverage is available for all women. More than 90 percent of women ages 40 to 75 currently have coverage for the Genius exam, and more than 16 million women in the U.S. get a Genius exam each year. The Genius exam detects 20-65 percent more invasive breast cancers and is the only mammogram approved by the FDA as superior for women with dense breasts compared to 2-D alone.1,2

The new Clarity HD high-resolution 3-D imaging technology provides what Hologic calls the industry's fastest, highest resolution 3-D images to accelerate screening and analysis, and is designed to clearly reveal subtle lesions and fine calcifications to help pinpoint cancers early. Clarity HD technology's advanced detector and innovative 3-D imaging algorithm work together to deliver high-quality 3-D images, regardless of breast size or density.

Intelligent 2-D imaging technology works with Clarity HD technology to deliver superior overall image quality, and clarity, contrast and detail at a lower dose.3,4

Another new feature, the SmartCurve breast stabilization system, is clinically proven to deliver a more comfortable mammogram without compromising image quality, workflow or dose.5 The SmartCurve system has been proven to improve comfort in 93 percent of women who reported moderate to severe discomfort with standard compression.5 It features a curved compression surface that mirrors the shape of a woman's breast to reduce pinching and allow uniform compression over the entire breast.

In addition, Quantra 2.2 Breast Density Assessment Software, also available on the 3Dimensions system, enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings. Breast density is only identifiable on a mammogram or other screening modality, and has historically been determined by the radiologist who reads the image. Through a proprietary algorithm powered by machine learning, Quantra software analyzes mammography images for distribution and texture of breast tissue, delivering clinicians accurate breast density assessment. Quantra software categorizes breasts into four density categories, in alignment with the American College of Radiology Breast Imaging-Reporting and Data System (ACR BI-RADS) Atlas 5th Edition.6,7

The Genius 3-D Mammography exam (also known as the Genius exam) is only available on a Hologic 3-D Mammography system. The Genius exam consists of a 2-D and 3-D image set, where the 2-D image can be either an acquired 2-D image or a 2-D image generated from the 3-D image set.

For more information: www.hologic.com

 

References

  1. Results from Friedewald, SM, et al. "Breast cancer screening using tomosynthesis in combination with digital mammography." JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia® Dimensions® on screening outcomes. Individual results may vary. The study found an average 41% increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1,000 screening exams were found in women receiving combined 2D FFDM and 3D™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only.  
  2. FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005.  
  3. Compared to C-view  
  4. Compared to 2D alone  
  5. Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00019 Rev 003 (2017).  
  6. FDA 510(k) K163623  
  7. Understanding Quantra™ (Version 2.2) User Manual

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