Approval of Siemens digital mammo nears
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.
Mammography Study Compares False Positives Between AI and Radiologists in DBT Screening
May 8th 2025For DBT breast cancer screening, 47 percent of radiologist-only flagged false positives involved mass presentations whereas 40 percent of AI-only flagged false positive cases involved benign calcifications, according to research presented at the recent American Roentgen Ray Society (ARRS) conference.
