FDA proposes new rules for mammography services



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The US Food and Drug Administration (FDA) has proposed a new policy to modernize and improve the quality of mammography used for bad cancer screening and diagnosis.

For the first time in more than two decades, these amendments require mammography centers to provide patients and their health care professionals with detailed information on bad density to enable more informed decision-making.

Mammographic images of bads with higher fibroglandular tissue compared to adipose tissue (dense bads) might be difficult to interpret because of unclear signs of cancer and a lower sensitivity.

The US regulator has proposed specific wording to explain the effect of bad density on the accuracy of mammography.

"As part of our overall commitment to protecting women's health, we are proposing new policies to modernize our surveillance of mammography services."

In addition, the new rules aim to provide health professionals with more information through three additional categories of mammography badessment.

FDA Commissioner Scott Gottlieb said, "As part of our overall commitment to protecting women's health, we are proposing new policies to modernize our surveillance system for mammography services by leveraging significant advances in mammography, such as digital screening tools and the need for more consistent reporting of bad density. "

The amendments also include notifications to patients and their health care professionals about the quality standards of mammography equipment and the components used.

The FDA has also proposed better record keeping to reduce the loss of information and improve access to and transfer of patient records.

Statistics from the National Cancer Institute (NCI) show that more than 260,000 women were diagnosed with bad cancer last year and that 40,920 women died as a result of the disease.

The disease is the second leading cause of death for women and can affect men of all ages. Mammography is considered an important method for detecting bad cancer.

A recent study from the Yale School of Public Health and the School of Medicine found that bad density reporting laws that require the disclosure of mammography results are linked to increased rates of detection and detection of bad cancer. Cancer.

In addition, some states also require that women with dense bads be screened such as ultrasound and MRI.

Laws recommending additional testing have been found to have higher rates of ultrasound cancer detection and bad cancer, compared to notifications containing only information on bad density.

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