The U.S. Food and Drug Administration has just updated its mammography regulations, affecting physicians and medical centers across the country. These updates will require mammography facilities to notify patients about the density of their breasts, and help interpreting physicians better categorize and assess mammograms.
Having mammographically dense breast tissue is normal and present in approximately 50% of women. However, it can make it harder for doctors to detect breast cancers on mammograms, leading to an alarming amount of cancers being missed when using mammography alone. Women with dense breast tissue also have a higher risk of developing breast cancer in the first place. Helping to promote patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an integral part of a better breast health strategy.
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 substantial improvement in early-stage cancer detection when compared to mammography. Vera by Koning can acquire these improved images in a matter of seconds and at radiation levels in the same range as conventional mammograms.
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Source: FDA.GOV News Release: FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight