Approval of Siemens digital mammo nears

Article

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.

Newsletter

Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.

Recent Videos
Leading Breast Radiologists Discuss Rise of Breast Cancer Incidence in Women Under 40
Diagnostic Imaging’s Weekly Scan: August 31 — September 6
Emerging Trends in Breast Imaging: An Interview with Zeeshan Shah, MD
© 2025 MJH Life Sciences

All rights reserved.