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Tomosynthesis Market Sees Competition with GE FDA Approval


GE’s SenoClaire breast tomosynthesis solution will join Hologic, the only other vendor with FDA approval for 3D mammography.

Three-dimensional breast imaging options are finally expanding, as GE Healthcare announced today United States Food and Drug Administration (FDA) approval of SenoClaire, GE’s new breast tomosynthesis solution.

GE collaborated with Massachusetts General Hospital to develop the SenoClaire technology, which uses a low-dose short X-ray sweep around the positioned breast with nine exposures taken in a “step-and-shoot” manner, the release said. The technology eliminates potential motion from the tube, which helps to reduce blur and increase image quality, according to the release.

With concern growing over radiation levels associated with screening mammography, GE ensured the SenoClaire technology would not have increased radiation from a 2D standard mammogram, the release said.

SenoClaire is compatible with Centricity PACS with Universal Viewer and supports the DICOM standard that can be read by capable PACS vendors, the release reported.

“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,” Murray Rebner, MD, FACR, a professor of diagnostic radiology and molecular imaging and director of the division of breast imaging and intervention at Beaumont Hospital, Royal Oak, Mich. “We believe this technology can have a significant impact on helping clinicians to identify breast cancer.”[[{"type":"media","view_mode":"media_crop","fid":"27493","attributes":{"alt":"GE SenoClaire ","class":"media-image media-image-right","id":"media_crop_1099140026163","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2691","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 140px; width: 175px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"GE SenoClaire","typeof":"foaf:Image"}}]]

GE will be rivaling the market dominator Hologic, who has owned the tomosynthesis market since 2011. Siemens is also looking to enter the market and is awaiting approval after submitting a premarket approval application in July.

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