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FDA Approves 3-D Mammography Device
The FDA has given “thumbs up” to SenoClaire, a new breast tomosynthesis device with three-dimensional (3D) imaging technology developed by General Electric Healthcare in collaboration with Massachusetts General Hospital.
The device uses a low-dose, short x-ray sweep around the positioned breast, with nine exposures acquired with a “step-and-shoot” method. This technique removes potential motion from the tube, which helps to reduce blur and increase image sharpness.
A key challenge when performing screening mammography is keeping the radiation levels as low as possible. According to GE, with the SenoClaire device, there is no increase in the radiation dose from a standard 2D mammogram to a 3D view.
“3D breast-screening technology helps clinicians uncover small cancers, which can be a limiting factor in standard 2D mammography,” said Murray Rebner, MD, FACR. “As a radiologist, it’s important to offer technology like this for patients that produces higher image quality without increasing the dose.”
In addition to offering increased image clarity and a low dose of radiation, SenoClaire helps to improve overall workflow, GE says. The device is compatible with Centricity 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 solution, clinicians have access to the patient’s longitudinal record, providing data that allow better patient care, according to the company.
Currently, GE Healthcare has 180 units of the mammography device installed in Europe, Australia, Latin America, Southeast Asia, and the Middle East.
Source: GE Healthcare; September 3, 2014.