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

FDA Clears Koios DS Breast 2.0 AI-based Software
News | Ultrasound Women's Health | July 11, 2019
Koios Medical announced its second 510(k) clearance from the U.S. Food and Drug Administration (FDA).
SimonMed Imaging Implements ProFound AI for 3-D Tomosynthesis
News | Mammography | July 10, 2019
Arizona-based SimonMed Imaging announced their implementation of the first U.S. Food and Drug Administration (FDA)-...
Therapixel Appoints Matthieu Leclerc-Chalvet as CEO
News | Artificial Intelligence | July 03, 2019
Artificial intelligence (AI) breast cancer screening specialist Therapixel announced the appointment of Matthieu...
GE Healthcare showcases Senographe Pristina Serena featuring its add-on-biopsy kit at the Breast Imaging Symposium. Photo by Greg Freiherr

GE Healthcare showcases Senographe Pristina Serena featuring its add-on-biopsy kit at the Breast Imaging Symposium. Photo by Greg Freiherr

Feature | Breast Imaging | July 03, 2019 | By Greg Freiherr
Productivity and its enabler — efficiency — guided the display of products at the April...
Countless possibilities can impact the future of global healthcare and AI is the first step toward breakthrough that will change the landscape of personalized medicine
Feature | Women's Health | July 03, 2019 | By Samir Parikh
Contrary to what many people believe,...

Image courtesy of GE Healthcare

Feature | Radiology Business | July 03, 2019 | By Jeffrey Hoffmeister, M.D.
Burnout in the medical profession is not uncommon, particularly as clinicians have become more overwhelmed by growing
iCAD ProFound AI

Image courtesy of iCAD

News | Breast Imaging | June 25, 2019
Use of...
Warm Springs Health & Wellness Center Implements Digisonics Solution for OB Ultrasound
News | Ultrasound Women's Health | June 17, 2019
Warm Springs Health & Wellness Center in Warm Springs, Ore., has selected the Digisonics OB PACS (picture archiving...
Fujifilm Announces Nationwide Breast Health Campaign With Mobile Mammography Coach

At the center of the campaign, Fujifilm will be traveling around the U.S. with its "Aspire to Be Fearless" mobile mammography coach to provide educational opportunities for clinicians, raise awareness about the importance of screening and will be providing mammograms to the underserved population in key locations.

News | Mammography | June 14, 2019
Fujifilm Medical Systems U.S.A. Inc. announced a nationwide awareness campaign titled ‘Aspire to Be Fearless’ focused...