Breast cancer screening plays a vital role in women’s healthcare, providing early detection that can significantly affect treatment outcomes. However, many women remain unaware of an important aspect of breast health: breast density. Recently, the FDA issued a ruling requiring all mammography facilities in the U.S. to inform patients of their breast density status.
This article explores breast density, its implications for cancer screening, the FDA’s new rule and how Aidoc’s partnership with ScreenPoint supports clinicians in meeting these standards through the Transpara Breast Density solution.
Breast density refers to the ratio of glandular and fibrous tissue to fatty tissue in a woman’s breast. Density levels are categorized into four levels:
a. The breasts are almost entirely fatty.
b. There are scattered areas of fibroglandular density.
c. The breasts are heterogeneously dense, which may obscure small masses.
d. The breasts are extremely dense, which lowers the sensitivity of mammography.
Women with “heterogeneously dense” or “extremely dense” breasts are considered to have dense breasts—a condition common in about 40-50% of women over 40.
Dense breast tissue affects screening in two key ways:
As of September 2024, the FDA mandates that all U.S. mammography facilities must provide patients with information about their breast density. Key aspects of the ruling include:
Historically, radiologists have visually estimated breast density, but assessments can vary widely. Studies indicate:
This subjectivity can lead to inconsistent density classifications, emphasizing the need for standardized, objective measures, particularly in light of the new FDA requirements.
In response to the need for reliable breast density assessments, Aidoc offers ScreenPoint’s fully automated, AI-driven Transpara Breast Density solution. This technology supports radiology teams in meeting MQSA compliance while enhancing assessment accuracy. Key features include:
The FDA’s new ruling is a significant step forward in empowering women to understand their breast health and assess personal cancer risk. With breast density information available, women can discuss additional screening options with their providers and make more informed healthcare decisions.
For radiologists and imaging facilities, the ruling underscores the importance of adopting reliable tools that deliver consistent breast density assessments. Aidoc’s offering of ScreenPoint’s Transpara Breast Density solution supports radiology teams in staying compliant with FDA standards while enhancing the quality of patient care.
The FDA’s mandate on breast density information represents a pivotal advancement in breast cancer screening. By requiring facilities to disclose breast density, the FDA empowers women with crucial health information, encouraging proactive management.
As a leader in AI-driven medical imaging, Aidoc is pleased to partner with ScreenPoint to offer a robust breast density solution that supports radiologists and imaging centers in meeting these new standards. With a focus on accuracy, flexibility and patient care, this partnership aims to improve outcomes for women with dense breasts, ensuring they receive the information and resources they need.
Citations
1 Sprague, Conant, et. al. Annals of Internal Medicine 2017. “Variation in Mammographic Breast Density Assessments Among Radiologists in Clinical Practice”https://doi.org/10.7326/M15-2934
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