Approval of Siemens digital mammo nears

July 16, 2004

The FDA has issued an approvable letter for Siemens Mammomat NovationDR, a full-field digital mammography system. The agency found that the device is approvable, pending successful FDA inspection of Siemens' manufacturing facility in Erlangen, Germany,

The FDA has issued an approvable letter for Siemens Mammomat NovationDR, a full-field digital mammography system. The agency found that the device is approvable, pending successful FDA inspection of Siemens' manufacturing facility in Erlangen, Germany, and agreement on the labeling to go with the system. The NovationDR, built around an amorphous selenium detector, supports digital screening, diagnosis, and stereotactic biopsy.