Thursday, December 19, 2013
GEHealthcare, a division of General Electric, announced in July that it had received the CE Marking for SenoClaire*, its next generation of GE breast tomosynthesis solutions which is designed with three-dimensional imaging technology. Much later in the month, it also submitted the final module of its pre-market approval application (PMA) to the U.S. Food and Drug Administration for the new equipment.
In the final module presented to the FDA, GE Healthcare included clinical study results as well as manufaturing data. The GE Breast Tomosynthesis Option has been designed as an add-on option for the Senographe*Essential system 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 Healthcare has a large Senographe Essential and Care, over 1,700, that are in clinical use in the United States today. SenoClaire*, the new generation of GE Breast Tomosynthesis solution is powered by ASiR*DBT 1, a technology that uses a low-dose short X-ray sweep around the positioned breast with nine exposures acquired with a "step-and-shoot" method, removing the potential motion from images.
Prahlad Singh, General Manager of the Women's Health Division of GE Healthcare - Detection & Guidance Solutions (DGS) commented, “We continue to innovate our portfolio and aim to help clinicians expand care to more women globally in order to help reduce breast cancer. Our goal was to pioneer an upgrade solution for both our digital mammography platforms, Senographe* Essential and Senographe Care, providing flexibility for customers to enhance their clinical offering for their clinic and patient workflow."
With SenoClaire, a single MLO view provides clinical non-inferiority compared to a 2-view digital mammography exam at half the dose, with just one compression. This solution has a potential to replace the existing digital mammography exams in screening to help radiologists detect breast cancer.
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