FDA approves pre-market application for Siemens mammography system
23 August 2004
MALVERN, Pa. The U.S. Food and Drug Administration (FDA) has granted
approval of the Pre-Market Approval Application (PMA) to Siemens Medical
Solutions for the MAMMOMATNovationDR
a full-field digital mammography system. The new MAMMOMAT NovationDR
meets the demands of modern mammography practices by providing digital
screening, diagnosis, and stereotactic biopsy capabilities — all in one
system.
“The MAMMOMAT NovationDR offers a comprehensive
solution for modern mammography that optimizes workflow, and furthers
Siemens’ ability to offer one of the most comprehensive women’s health
solutions available today. With this innovative new system, screening,
diagnosis and biopsy all can be performed on a single unit,” said Holger
Schmidt, president of the Siemens Medical Solutions Special Systems
Division. “Thanks to the combination of proprietary detector technology and
our unique X-ray tube, both image quality and dose exposure reduction
achieve an optimum level. In addition, the system’s acquisition and
reporting stations deliver optimized workflow. Clearly, Siemens is offering
an investment in the future of digital mammography.”
The new MAMMOMAT NovationDR features an innovative flat
panel detector based on amorphous Selenium (aSe) detector technology. This
technology enables a direct conversion of X-ray to digital information,
unlike some other detector systems, such as amorphous silicon (aSi-CsI),
which use indirect x-ray conversion. The aSe detector technology has the
potential to provide higher spatial resolution and greater clinical detail.
At 24 by 29 centimeters, the image detector size of the MAMMOMAT NovationDR
also enables imaging of a larger range of patient sizes, and the system
features a new paddle designed for easier and more comfortable patient
positioning.
A unique feature of MAMMOMAT NovationDR is the
MammoReportPlus, our dedicated workstation for mammography, which
provides high-volume mammogram reading and optimized workflow. 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. MammoReportPlus also is designed
to meet future imaging needs and is prepared for digital computer-aided
(CAD) applications.
The MAMMOMAT NovationDR digital system is based on the
company’s flagship analog mammography product—the MAMMOMAT 3000 Nova. The
connectivity features of both the MAMMOMAT 3000 Nova and the new MAMMOMAT
NovationDR are clear examples of Siemens’ demonstrated
leadership in image data and workflow management, and will facilitate the
new system’s integration into a digital network, potentially improving
patient management and care.
More information can be obtained by visiting:
www.usa.siemens.com
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