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.
Is the Kaiser Score More Effective than BI-RADS for Assessing Contrast-Enhanced Mammography and MRI?
October 14th 2024For women with breast-enhanced masses, Kaiser scoring (KS) demonstrated a 20 percent higher AUC than BI-RADS classification for contrast-enhanced mammography (CEM) and was comparable to KS for breast MRI.
FDA Clears New Features in AI-Powered Mammography Software Suite
October 11th 2024Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.
Multicenter Study Identifies Key Factors Associated with Mammogram-Occult Ipsilateral Breast Cancer
October 9th 2024A symptomatic first breast cancer diagnosis, prevailing breast density at a second breast cancer diagnosis and trabecular thickening on surveillance mammography were linked to mammogram-occult ipsilateral breast cancer, according to new research.
Radiology Experience, Breast Density and Screening Mammography: What New Research Reveals
October 4th 2024In a study looking at the impact of experience and case volume of breast screening radiologists, researchers found that reviewing more than 150 cases per week was necessary to achieve an 80 percent rate of true-positive assessments for malignant calcifications.