News | Breast Imaging | August 08, 2016

FDA Breast Imaging Panel Discusses New Ways to Better Assess Mammography Quality

Dense breast tissue’s impact on exam quality will be discussed

dense breast tissue, dense breast imaging, BIRADS, BI-RADS, mammography grading system, comparison of dense breast tissue, Fibroglandular densities

August 8, 2016 — The U.S. Food and Drug Administration’s (FDA) National Mammography Quality Assurance Advisory Committee is considering new measures to improve breast imaging quality and how breast density impacts exams. The panel will discuss these and other items at its next meeting Thursday, Sept. 15, 2016, in Gaithersburg, Md.

The committee provides advice and recommendations to the FDA on agency’s regulatory issues.

The committee will discuss and make recommendations on compliance analysis, focusing on the Mammography Quality Standards Act (MQSA) current compliance trends. The discussion will include trends seen in the analysis, why the trends may be occurring and possible actions that should be sought.     

The panel will also discuss the Inspection Enhancement Project, which is proposes to use the inspection program to enhance breast image quality. FDA is seeking committee input on anticipated facility questions related to the proposal. The approved alternative standard American College of Radiology Full Field Digital Mammography Quality Control Manual contents will be explained and FDA will ask the committee's  advice on facility roll-out strategies.     

The committee will also address issues related to breast density (fibroglandular densities). A presentation will examine the current issues, followed by a committee discussion on how these issues might effect a possible MQSA requirement for reporting breast density.  Future challenges for MQSA include the role of synthesized 2-D images created from 3-D tomosynthesis mammography datasets. The FDA is seeking committee input on this challenge, as well as what future challenges MQSA might encounter.   

Read more about MQSA Mammography Facility Inspector Training. 

For more informtion: www.fda.gov/AdvisoryCommittees/Calendar/ucm515098.htm

 

Related Content

Joseph J. Cappello Named Executive Director of Are You Dense Nonprofits
News | Breast Density | February 20, 2019
The boards of Are You Dense Inc. and Are You Dense Advocacy Inc., founded by the late Nancy M. Cappello, Ph.D.,...
Congress Directs FDA to Establish Federal Breast Density Inform Standard
News | Breast Density | February 19, 2019 | Jeff Zagoudis, Associate Editor
As part of a federal spending bill passed late Friday, Congress directed the U.S. Food and Drug Administration (FDA) to...
Densitas Enters Partnership Agreement With TeleMammography Specialists
News | Breast Density | February 14, 2019
Breast imaging analytics company Densitas Inc. announced a new collaboration partnership with TeleMammography...
Hologic Launches Unifi Analytics Business Intelligence Tool
Technology | Analytics Software | February 12, 2019
Hologic Inc. announced the U.S. launch of Unifi Analytics, a business intelligence tool that allows healthcare...
Mount Sinai's Digital 3-D Mammography Van Rolls Into New York City
News | Mammography | February 11, 2019
Mount Sinai Hospital recently launched the Mount Sinai Mobile Mammography Program (MMP), bringing essential breast...
breast density cancer awareness
News | Breast Density | February 08, 2019
Governor Michelle Lujan Grisham has signed breast density inform bill, ...
Fujifilm Launches Latest Synapse 3D Version at HIMSS 2019

The new Intravoxel Incoherent Motion (IVIM) MR application in Synapse 3D

Technology | Advanced Visualization | February 08, 2019
Fujifilm Medical Systems U.S.A. will debut the latest version of its Synapse 3D solution at the Healthcare Information...
Siemens Healthineers Syngo.Breast Care Adding AI-Based Decision Support
News | Clinical Decision Support | February 05, 2019
Siemens Healthineers showcased the new planned artificial intelligence (AI)-based features with its mammography reading...
 Volpara Solutions Launches Next-Generation VolparaDensity Software to Support SmartCurve Paddles
Technology | Breast Density | January 31, 2019
Volpara Solutions Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for new technologies used in...
QTbreasthealth Opens New Breast Ultrasound Imaging Center in Grand Rapids
News | Ultrasound Women's Health | January 30, 2019
January 30, 2019 — QTbreasthealth launched a center in Grand Rapids, Mich., featuring its quantitative transmission