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.
AI-Initiated Recalls After Screening Mammography Demonstrate Higher PPV for Breast Cancer
March 18th 2025While recalls initiated by one of two reviewing radiologists after screening mammography were nearly 10 percent higher than recalls initiated by an AI software, the AI-initiated recalls had an 85 percent higher positive predictive value for breast cancer, according to a new study.