FDA approves Siemens full-field digital mammo system

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Siemens Medical Solutions is now the fourth member of the full-field digital mammography (FFDM) pack, announcing this week that the U.S. Food and Drug Administration (FDA) has granted approval of its pre-market approval application for the Mammomat Novation system.

Novation features a pivoting bucky, allowing sites to complete both screening and diagnostic studies as well as stereotactic biopsies on one system. By swinging the arm to a wing equipped with the Opdima spot-imaging device, the technologist can complete diagnostic workups, spot compression views with a resolution up to 20 line pairs, and stereotactic biopsies. The arrangement could save space and enhance workflow. The Novation includes a 25-by-29 cm amorphous selenium detector to facilitate imaging of a wide range of patient breast sizes. The system is not upgradable to other Siemens units, but the company is offering "aggressive" customer loyalty programs for Siemens Nova and Mammomat 3000 users, according to Joanne Scott Santos, manager, Women's Health.

Siemens said the connectivity features of both the analog and digital device will facilitate the new system's integration into a digital network as well as improve data and workflow management.

"Thanks to the combination of proprietary detector technology and our unique x-ray tube, both image quality and dose exposure reduction achieves an optimum level," said Holger Schmidt, president of the Siemens Medical Solutions Special Systems Division. "In addition, the system's acquisition and reporting stations deliver optimized workflow."

"Siemens has been doing research on digital mammography for a number of years," Scott Santos said. "We were originally going the amorphous silicon route. About four years ago, we decided amorphous selenium was the better medium for breast imaging due to its smaller pixel size, better resolution and better DQE [detector quantum efficiency]. The market is moving toward digital imaging and we believe digital imaging is going to bring better technology for breast imaging for women and hopefully assist in earlier detection."

Another unique feature of the Novation is the MammoReader (Plus), Siemens' dedicated workstation for mammography, which provides high-volume mammogram reading. The system's dedicated keypad and roaming/panning function gives easy-to-full spatial resolution and allows users to switch between eight-view mammographic studies in less than one second.

In addition, MammoReport(Plus) is designed to meet future imaging needs and is prepared for digital computer-aided (CAD) applications.

UCLA Medical Center was the site of Siemens' clinical research, while the company is conducting tomosynthesis research at Duke University Medical Center. The first units will be installed at the University of Utah, Medical College of Virginia and New York University, according to Scott Santos. Production of the systems began in January after the European regulatory approval of the system, so U.S. deliveries are ramping up quickly. There are about 20 units currently installed in Europe.