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.
Five Insights on Artifacts and Limitations with Contrast-Enhanced Mammography
February 29th 2024Noting that technique issues, patient positioning miscues and atypical features can all contribute to faulty interpretation with contrast-enhanced mammography (CEM), researchers at the European Congress of Radiology shared their insights on navigating artifacts and limitations with CEM.
Moving Beyond Mammography for Screening and Staging of Invasive Lobular Carcinoma
February 16th 2024For women with dense breasts, only 25 percent of breast radiologists are confident in the use of mammography for diagnosing invasive lobular carcinoma, according to newly published survey results from the Society of Breast Imaging.