FDA Mandates Breast Density Notification

As of September 10, 2024, the Food and Drug Administration requires mammography facilities to provide women with standardized information about their breast density. This regulation ensures that women nationwide are informed about the risks associated with breast density, advised that other imaging tests might help find cancers, and urged women to talk with their doctors about next steps based on their individual situation.

A mammography facility must now provide each patient with a summary of the results of the exam in lay terms. The assessment of breast density must be classified in one of these categories:

• “The breasts are almost entirely fatty.”
• “There are scattered areas of fibroglandular density.”
• “The breasts are heterogeneously dense, which may obscure small masses.”
• “The breasts are extremely dense, which lowers the sensitivity of
• mammography.”

The Koning team applauds the implementation of a National Breast Density Reporting Standard as it will quite literally have life-changing consequences for women in the U.S. Dense breasts are far from anomalous as approximately 50% of women have dense breast tissue that can make breast cancer detection harder on mammograms. These women also have a higher risk of developing breast cancer in the first place. Access to personal information about the risks of breast density should never have taken this long to ensure. 

While the new policy helps to bring mammography to the 21st century, Koning has long been advocating to notify women of their breast density. Our FDA -cleared, dedicated Koning Vera Breast CT device is especially effective in analyzing dense breast tissue when using contrast, increasing specificity and allowing for significant improvement in early-stage cancer detection when compared to mammography. Our device can acquire these improved images in a matter of seconds and at radiation levels in the same range as conventional mammograms, maximizing accuracy for all women, regardless of the type of breast tissue. 

Find a KBCT location near you.

Source: FDA.gov, Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide