Market Overview

GE Healthcare Issues Final Module of Premarket Approval App for GE Breast Tomosynthesis Option

Share:
Related GE
3D Printing Facility Could Be Alcoa's Path To Modernization
GE Capital Finances Acquisition of Futures Behavior Therapy Center, LLC by Community Intervention Services, Inc.
Boeing Can Still Manage Deliveries Without Ex-Im Bank (Investor's Business Daily)

GE Healthcare, a unit of General Electric Company (NYSE: GE), announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval application (PMA^1) for GE Breast Tomosynthesis, an option of the Senographe* Essential system.

In this final PMA^1 module, GE Healthcare has provided the FDA with clinical study results and manufacturing information. The GE Breast Tomosynthesis option has been designed as an add-on option for the Senographe Essential that will acquire multiple projection views to produce 3D Digital Breast Tomosynthesis (DBT) images, intended to be suitable for screening and diagnosis of breast cancer. GE has a large Senographe Essential and Care installed base in clinical use in the USA.

Over 1700, Senographe Essentials are in clinical use in the United States today.

Posted-In: News FDA

 

Related Articles (GE)

Get Benzinga's Newsletters