News | November 22, 2010

3-D Digital Mammography Tomosynthesis System Receives ‘Approvable Letter’

November 23, 2010 — The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has issued an “approvable letter” for the Selenia Dimensions system for breast tomosynthesis (3-D) imaging.

Clinical studies have shown that breast tomosynthesis technology will significantly reduce patient recall rates and improve cancer detection. The Selenia Dimensions system for breast tomosynthesis (3-D) imaging addresses many of the limitations present in stand-alone 2-D mammography and improves upon both sensitivity and specificity. Hologic is the first to receive an FDA “approvable letter” for this new technology.

Selenia Dimensions 3-D digital mammography tomosynthesis systems are installed in more than a dozen countries, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. After a plant inspection to ensure its manufacturing facilities, methods and controls are in compliance with the applicable requirements of the Quality System regulation, Hologic can begin commercial distribution of the new system in the United States.

For more information: www.hologic.com

Related Content

Lunit Unveiling AI-Based Mammography Solution at RSNA 2018
News | Mammography | November 15, 2018
Medical artificial intelligence (AI) software company Lunit will be returning to the 104th Radiological Society of...
Breast Density Advocate Nancy M. Cappello Passes Away

Nancy Cappello. Image courtesy of AreYouDense.org.

News | Breast Density | November 15, 2018 | Jeff Zagoudis, Associate Editor
Imaging Technology News extends its condolences to the family, friends and colleagues of Nancy M. Cappello, Ph.D., who...
Merit Medical Completes Acquisition of Cianna Medical
News | Women's Health | November 14, 2018
Disposable device manufacturer Merit Medical Systems Inc. announced the closing of a definitive merger agreement to...
Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
Sponsored Content | Videos | Digital Radiography (DR) | November 12, 2018
VIVIX-S 1417N is a multi-purpose portable flat panel detector for addressing busy workflow in medical facilities.
ContextVision Introduces AI-Powered Image Enhancement for Digital Radiography
Technology | Artificial Intelligence | November 09, 2018
With the integration of deep learning technology, ContextVision takes digital radiography to new levels with its latest...
The MOZART Supra Specimen Tomosynthesis System is the latest generation of 3-D imaging for breast cancer surgery.
News | Breast Imaging | November 08, 2018
KUBTEC announced the launch of a new innovation in the treatment of breast cancer. The Mozart Supra Specimen...
Charles Ananian, M.D.

Charles Ananian, M.D.

Sponsored Content | Case Study | Digital Radiography (DR) | November 07, 2018
Whether it’s a premature baby or a critically ill child, treating little patients is a huge responsibility.
Feature | Breast Imaging | November 07, 2018 | By Jeff Zagoudis
Breast imaging technology has experienced major growth over the last decade or so, and a new report suggests the mark