Devices

Require Better De Novo Evidence: Researchers

Researchers from Yale University and the University of California San Francisco say that FDA could ensure that better evidence is generated to guide clinical decision-making by requiring that medical devices cleared through the de novo pathway meet prespecified effectiveness endpoints for clearance. They also say that postmarket studies should include larger patient populations.

Writing in a JAMA Internal Medicine Research Letter, the authors say that the larger postmarket studies “could be particularly informative for devices cleared without pivotal studies and those that failed to meet effectiveness endpoints.”

The researchers say that between 2011 and 2019, FDA cleared most novel moderate-risk therapeutic devices via the de novo pathway based on pivotal clinical studies. However, they say, some 20% of devices were cleared without pivotal clinical studies, and some 33% were based on pivotal studies that failed to meet at least one primary endpoint.

“Nevertheless,” the report says, “FDA rarely required postmarket studies and devices cleared through the de novo pathway often served as the basis for new models and competitor products subsequently cleared via the 510(k) process.”

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