Breast Tomosynthesis Option Acquires Multiple Projection Views for 3D Images

Giles, UK), a unit of General Electric Company (Fairfield, CT, USA), recently submitted to the US Food and Drug Administration (FDA) the first module of its premarket approval application (PMA) for GE breast tomosynthesis, an option of the Senographe Essential system.

In this first PMA module, GE Healthcare has provided the FDA with the device description and nonclinical information, including phantom testing, and detector performance evaluation. Over 1,200 Senographe Essentials are in clinical use in the United States today.

Earlier in the summer of 2011, GE Healthcare received agreement from FDA to proceed with a PMA modular submission consistent with the application shell proposed by GE. The modular review approach is a mechanism that allows applicants to submit preclinical data and manufacturing information for FDA review while the applicant continues to collect, compile, and analyze clinical data for the submission. A modular PMA is a compilation of sections or “modules” submitted at different times that together become a complete premarket approval application. The modular approach increases the probability that an applicant will be able to resolve deficiencies identified by FDA earlier in the review process than would occur with a traditional PMA application. GE Healthcare intends to file the remaining three modules of its DBT PMA with the FDA over 2012.

“Worldwide, more than 1.2 million people annually are diagnosed with breast cancer. Since 1965, GE Healthcare has made significant progress in providing solutions for breast cancer detection and diagnosis that really bring a change to people’s lives. Today, through ‘healthymagination,’ we continuously develop innovations to reduce costs, increase access, and improve quality and efficiency of healthcare delivery around the globe,” said Anne LeGrand, GE Healthcare’s vice president and general manager of the company’s global X-ray business.

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