Dense breast tissue is one of the most overlooked factors in women’s health. Nearly half of women fall into this category, yet the way it affects both cancer risk and cancer detection has not been adequately addressed by traditional breast imaging. Dense breast tissue can mask tumors because both appear white, creating a visual overlap that leaves cancers undetected. At the same time, dense tissue itself increases the risk of developing breast cancer. This double challenge means that too many women face uncertainty when they should have reliable answers.
Over the past decade, states began requiring that women be notified if they have dense breasts. In September 2024, the Food and Drug Administration extended that standard nationwide. Patients now receive formal notification, but the next question is what happens after they learn this information. Telling women about density is only a first step. They also need access to imaging that can see past it.
Our Koning Vera was designed to address this exact problem. Instead of flattening the breast into a two-dimensional image, Vera creates a full three-dimensional scan. Radiologists can examine the tissue without overlapping structures obscuring potential abnormalities. This technology has shown promise in improving the detection of cancers hidden on other breast imaging modalities, particularly in women with dense breasts.
Equally important is the way Vera changes the experience of the exam. Some traditional imaging modalities require significant compression of the breast, which many patients find painful. Studies show that discomfort keeps some women from returning for recommended annual exams. With Vera, the process is different: A patient lies comfortably on the table while the scan is completed in less than ten seconds, without compression. That shift matters because technology that works for women must take into account not only accuracy but also comfort.
The Koning Vera has received approval from the FDA as a dedicated breast CT device for diagnostic imaging and for guided biopsy. This recognition confirms its place in the clinical pathway, particularly for women who require additional imaging beyond mammography. For patients and clinicians alike, Vera offers a more complete picture and a less stressful process.
World Dense Breast Day calls attention to an area where medicine has too often relied on partial solutions. Dense breast tissue should not limit the chance of early detection, nor should breast imaging come at the expense of comfort. Technology now exists to meet those needs, and it is time to bring it within reach of the women who depend on it. At Koning, we remain focused on that goal.
Sources
U.S. Food and Drug Administration. FDA Mammography Quality Standards Act: Breast Density Notification Final Rule. 2024.
Sprague BL, et al. “Prevalence of mammographically dense breasts in the United States.” Journal of the National Cancer Institute, 2014.
O’Connell, Avice M. et al. “Cone-Beam Breast Computed Tomography: Time for a New Paradigm.” Radiographics, 2021.
Li H, et al. “Comparison of comfort between cone beam breast CT and mammography.” European Radiology, 2019.