FDA Updates Breast Density Reporting Standards, Other Mammogram Rules

Dense breasts place people at higher risk of breast cancer but also make it harder to pick up abnormalities on x-rays. A new rule by the US Food and Drug Administration (FDA) standardizes the information patients receive from their mammogram providers about their breast density. It also requires language prompting patients—particularly those with dense breasts—to talk in greater depth with their physicians about their results and whether additional imaging makes sense.

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Aprile 2023

FDA Approves First Over-the-counter Combined COVID-19 and Flu Test

In late February, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization to an at-home diagnostic test that identifies SARS-CoV-2, the virus that causes COVID-19, as well as influenza strains A and B. The test detected 100% of negative and 88.3% of positive COVID-19 samples, 99.3% of negative and 90% of positive influenza A samples, and 99.9% of negative influenza B samples.

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Marzo 2023