Devices

Breast Density Notification Rule Due Soon: DeLauro

Rep. Rosa DeLauro (D-CT) says she has been informed by FDA that a new breast density notification rule is to be published by the end of 2022 or early in 2023. The rule would require that mammography reports to women and their healthcare providers notify patients if they have dense breasts and the need for additional breast cancer screenings. It was mandated by the Breast Density and Mammography Reporting Act, the terms of which were included in the 2019 FDA funding bill.

“After three years, I am pleased that FDA has finally communicated that they believe they will be able to roll out a rule requiring providers to notify women of whether they have dense breasts, what this means for their risk of breast cancer, and the importance of speaking with a healthcare provider about breast density,” DeLauro said in a statement…. “I urge FDA to move swiftly to release the final rule before the end of the year.”

The funding bill amended the Public Health Services Act to direct FDA to develop reporting language and ensure that mammography reports and summaries received by patients and their healthcare providers include information that:

explains the effect of breast density in masking the presence of breast cancer on a mammogram;
provides a qualitative assessment of breast density by the radiologist who interprets the mammogram; and
includes a reminder to patients that individuals with dense breast tissue should talk with their healthcare providers if they have questions or concerns.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome