FDA clears GE FFDM unit for mobile use

GE Healthcare of Chalfont St. Giles, U.K., has received U.S. Food and Drug Administration (FDA) clearance to market its Senographe Essential full-field digital mammography (FFDM) system for mobile use.

GE conducted a series of tests on Senographe Essential to validate the system for mobile operation, such as testing the unit's ability to operate in extreme conditions. The company is also offering a specialized service package for the system.

GE believes that Senographe Essential is well suited for mobile use due to the system's 24 x 31-cm detector size, which means the unit can be used for a wide variety of breast sizes. GE is also planning to tout the relatively small file sizes of the images produced by the system, making it easier to distribute images electronically such as via teleradiology.

A clinical evaluation unit of the mobile Senographe Essential system is in operation in the BreastCheck national screening program in Ireland, and Dr. Constance Lehman of Seattle Cancer Care Alliance and the University of Washington in Seattle has been using the first unit installed in the U.S.

By AuntMinnie.com staff writers
August 22, 2007

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