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-Based Deep Learning Model Facilitates Higher Breast Cancer Detection on Screening MRI
September 22nd 2023New research suggests the capability of a mammography-based deep learning model to identify women at high risk of breast cancer led to more than triple the cancer detection rate on breast MRI in comparison to traditional risk assessment tools.
Can AI Match Radiologist Assessment of Screening Mammography Exams?
September 5th 2023In separate test sets that included challenging mammography cases, researchers found that artificial intelligence (AI) demonstrated similar sensitivity and specificity for detecting breast cancer in comparison to assessments from over 500 clinicians.
New Research Shows Consequences of Delayed Diagnosis in Mammography Screening
August 22nd 2023Primary diagnostic delays in mammography screening led to a greater than 10 percent higher incidence of lymph node metastasis with invasive breast cancer in comparison to women without a primary diagnostic delay, according to new research out of the Netherlands.
Study Reveals Tradeoffs Between Contrast-Enhanced Mammography and MRI for Supplemental Screening
August 16th 2023In a new study comparing standard breast MRI, abbreviated breast MRI and contrast-enhanced mammography in supplemental breast cancer screening, researchers found that MRI offered a greater than 14 percent higher cancer detection rate and a nearly 39 percent higher sensitivity rate than CEM.
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