Siemens Medical Solutions will soon join the digital mammography market, with the announcement today that it received an approvable letter from the U.S. Food and Drug Administration for the MAMMOMAT NovationDR full-field digital mammography system.
This letter indicates that the FDA has completed its scientific review of the company's Pre-Market Approval (PMA) application.
In the approvable letter for this device, the FDA indicated that the MAMMOMAT NovationDR is approvable for release to the market, pending the successful completion of an FDA inspection of Siemens' manufacturing facility in Erlangen, Germany, and completion of the device labeling for the system. No timeframe for this was given.
The new MAMMOMAT NovationDR provides digital screening, diagnosis and stereotactic biopsy capabilities - all in one system. It features a flat-panel detector based on amorphous Selenium (aSe) technology, enabling a direct conversion of X-ray to digital information. The aSe detector technology has the potential to provide higher spatial resolution and greater clinical detail.
At 25 by 29 centimeters, the size of the MAMMOMAT NovationDR image detector enables imaging of a wide range of patient breast sizes. The system also features an acquisition workstation and the MammoReportPlus, a dedicated softcopy reporting workstation that allows ultra-fast loading times. One case with eight images can load in less than one second, Siemens said.