Siemens Medical Solutions announced yesterday that the FDA has approved a PMA supplement to allow marketing of the MAMMOMAT Novation DR for mobile use. Medical facilities can now use the full field digital mammography system with a mobile coach for improved functionality and flexibility, the company said.
Siemens' MAMMOMAT Novation DR provides digital screening, diagnosis and stereotactic biopsy capabilities and enables clinicians to better pinpoint disease and plan treatment. With the mobile configuration, medical facilities can bring digital mammography directly to their patients and offer comprehensive women's health services on the road.
The system features a flat panel detector-based on amorphous Selenium (aSe) technology, and enables a direct conversion of x-ray to digital information. The aSe detector technology can potentially provide higher spatial resolution and greater clinical detail, which aid clinicians in their diagnosis. In addition to optimal image quality, the combination of proprietary detector technology and the x-ray tube result in dose exposure reduction.
At 24 by 29 centimeters, the size of MAMMOMAT Novation image detector also allows imaging of a wide range of patient breast sizes, and its paddle is designed to provide easier and more comfortable patient positioning. In addition, the system's acquisition and reporting stations deliver optimized workflow. It can work with Siemens MammoReport(Plus), a multi-modality workstation for mammography with the ability to accept CAD markers from approved vendors.