Devices

FDA Updates Essure Web Page

FDA has updated its Essure Web page with information on medical device reports about Essure received in 2018. The agency says it continues to post the latest information about Bayer’s postmarket surveillance study on the 522 study Web page. The company withdrew Essure from the market at the end of 2018.

FDA says it received about 6,000 medical device reports in 2018 related to Essure, down from the nearly 12,000 received in 2017, and about the same as in 2015 and 2016.

The update to the study Web page includes the number of participants enrolled in the postmarket surveillance study that FDA ordered Bayer to conduct in 2016. As of 4/1, it says, there were 891 patients enrolled in the study, with 307 enrolled in the group who elected Essure and 584 in the group who elected laparoscopic tubal ligation. FDA says it considers this to be adequate progress.

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