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FDA releases digital mammography rules
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.
Study: Mammography AI Leads to 29 Percent Increase in Breast Cancer Detection
February 5th 2025Use of the mammography AI software had a nearly equivalent false positive rate as unassisted radiologist interpretation and resulted in a 44 percent reduction in screen reading workload, according to findings from a randomized controlled trial involving over 105,000 women.
Can AI Bolster Breast Cancer Detection in DBT Screening?
January 16th 2025In sequential breast cancer screening with digital breast tomosynthesis (DBT), true positive examinations had more than double the AI case score of true negative examinations and the highest positive AI score changes from previous exams, according to new research.
Mammography Study Suggests DBT-Based AI May Help Reduce Disparities with Breast Cancer Screening
December 13th 2024New research suggests that AI-powered assessment of digital breast tomosynthesis (DBT) for short-term breast cancer risk may help address racial disparities with detection and shortcomings of traditional mammography in women with dense breasts.
Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
November 29th 2024Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.
