The Food and Drug Administration has released a draft versionof rules intended to guide manufacturers through the regulatoryreview process for full-view digital mammography devices (SCAN9/13/95). The guidelines cover several areas, including a
The Food and Drug Administration has released a draft versionof rules intended to guide manufacturers through the regulatoryreview process for full-view digital mammography devices (SCAN9/13/95). The guidelines cover several areas, including a draftprotocol for a clinical study to demonstrate the agreement interms of effectiveness between digital and analog mammographyfor screening applications, as well as a draft protocol for aclinical study to establish the sensitivity, specificity and othercharacteristics of screening digital mammography. The FDA is requestingthat interested parties submit their comments on the draft guidelinesto the agency by Oct. 30.
Current Insights and Emerging Roles for Contrast-Enhanced Mammography
May 10th 2024In a recent lecture at the 2024 ARRS Annual Meeting, Jordana Phillips, MD, discussed the role of contrast-enhanced mammography in staging breast cancer, evaluating response to neoadjuvant chemotherapy and recalls from screening.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.