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

At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve).

At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve). Photo by Greg Freiherr

Feature | Cardiac Imaging | March 22, 2019 | By Greg Freiherr
Reflecting a trend toward the increased use of...
Hologic Opens Learning and Experience Centre in Zaventem, Belgium
News | Women's Health | March 21, 2019
Hologic Inc. opened its first Learning and Experience Centre in Zaventem, Belgium. The state-of-the-art facility...
QTbreasthealth Opens Breast Imaging Center in San Jose
News | Ultrasound Women's Health | March 20, 2019
QTbreasthealth has opened a new center in San Jose, Calif. The new location is now open and booking appointments for...
FDA Clears Mobilett Elara Max Mobile X-ray from Siemens Healthineers
Technology | Digital Radiography (DR) | March 20, 2019
The U.S. Food and Drug Administration (FDA) has cleared the Mobilett Elara Max mobile X-ray system from Siemens...
Older Biologic Age Linked to Elevated Breast Cancer Risk
News | Women's Health | March 19, 2019
Biologic age, a DNA-based estimate of a person’s age, is associated with future development of breast cancer, according...
PET Scans Show Biomarkers Could Spare Some Breast Cancer Patients from Chemotherapy
News | PET Imaging | March 18, 2019
A new study positron emission tomography (PET) scans has identified a biomarker that may accurately predict which...
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.

SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram. Results from an international study presented at #ACC19 show that pressure readings in coronary arteries may identify locations of stenoses remaining after cardiac cath interventions.

Feature | Cardiac Imaging | March 18, 2019 | By Greg Freiherr
As many as one in four patients who undergo cath lab interventions can benefit from a technology that identifies the
Jennifer N. A. Silva, M.D., a pediatric cardiologist at Washington University School of Medicine in Saint Louis, Mo., describes “mixed reality” at ACC19 Future Hub.

Jennifer N. A. Silva, M.D., a pediatric cardiologist at Washington University School of Medicine in Saint Louis, Mo., describes “mixed reality” at ACC19 Future Hub.

Feature | Cardiac Imaging | March 17, 2019 | By Greg Freiherr
Virtual reality (VR) and its less immersive kin, augmented reality (AR), are gaining traction in some medical applica
WVU cardiology chief Partho Sengupta, M.D., describes at ACC 2019 how artificial intelligence already helps cardiologists in echocardiography.

WVU cardiology chief Partho Sengupta, M.D., describes at ACC 2019 how artificial intelligence already helps cardiologists in echocardiography. Photo by Greg Freiherr

Feature | Cardiac Imaging | March 16, 2019 | By Greg Freiherr
Machine learning is already having an enormous impact on cardiology, automatically calculating measurements in echoca