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United States : GE Healthcare Announces FDA Approval of SenoClaire, New Breast Imaging with 3D Tomosynthesis Solution

September 4, 2014

GE Healthcare today announced the FDA approval of SenoClaire, GE s new breast tomosynthesis solution designed with a three-dimensional imaging technology. In collaboration with Massachusetts General Hospital, GE developed SenoClaire 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 the tube helping to reduce blur and increase image sharpness.

Today s announcement marks a key milestone in our mission of providing women with cutting edge screening technology to detect early breast cancer, said Dr. Daniel Kopans, Senior Radiologist, Breast Imaging Division Department of Radiology, Massachusetts General Hospital. When cancer is identified and treated earlier, we know women have a better rate of survival.

A key challenge when performing screening mammography is keeping the radiation levels as low as possible. With GE s SenoClaire, there is no increase in dose from a 2D standard mammogram to a 3D view, which means there is no increased radiation to patients during a SenoClaire breast exam. ­­ 3D breast screening technology helps clinicians uncover small cancers which can be a limiting factor in standard 2D mammography. As a radiologist, it s important to offer technology like this for patients that produces higher image quality without increasing dose, said Dr. Murray Rebner MD, FACR, Professor of Diagnostic Radiology and Molecular Imaging at Oakland University William Beaumont School Of Medicine and Director of the Division of Breast Imaging and Intervention at Beaumont Hospital, Royal Oak.¹ We believe this technology can have a significant impact on helping clinicians to identify breast cancer.

In addition to offering more clarity, confidence and low dose, SenoClaire offers a complete solution by helping to improve overall workflow. SenoClaire is compatible with CentricityTM PACS with Universal Viewer and supports the DICOM standard that can be read by capable PACS vendors. When SenoClaire is combined with GE Healthcare s Centricity PACS and Centricity Clinical Archive solution², clinicians have access to the patient s longitudinal record, providing data that helps to enable better patient care.

With the FDA s approval of SenoClaire, we build on our breast care continuum which offers physicians and patients a complete suite of solutions from screening and diagnosis through treatment and monitoring, said Catherine Tabaka, Chief Marketing Officer, GE Healthcare, Detection and Guidance Solutions. SenoClaire not only offers patients a new solution to help clinicians better detect breast cancer, but does so with low dose radiation and high image quality.

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Source: TendersInfo (India)

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