Devices

Device Approvals Slow to 10-Year Low: Report

FDA approved nine new or substantially changed high-risk medical devices in the first quarter of 2025, the lowest number of approvals in 10 years. The Minneapolis Star Tribune reports there were 13 such devices approved in the comparable period in 2024 and 14 in 2023. The newspaper says the lower number of reported decisions is happening even though the agency had more applications for high-risk devices pending on 12/31/2024 than on the same date in 2023.

“The apparently slower performance comes as industry observers worry that CDRH staffing changes will slow down product reviews, which can already last years,” the story says. “Financial analysts say companies are uncertain how the cuts will affect regulatory timelines, which help determine future financial projections.”

The Star Tribune says medical device reviewers it spoke with indicated the agency has been less efficient as a result of two rounds of layoffs.

The newspaper says classifications for de novo medical devices declined to a five-year low for the first quarter.

The report quotes an HHS response to the newspaper’s request for comment that FDA “will focus on streamlining operations and centralizing administrative functions as part of HHS’ transformation initiative to make the agency more efficient and responsive. The reduction did not affect drug, medical device, or food reviewers, nor impacted inspectors. The critical work will continue.”

The paper spoke to an employee who is on administrative leave and who said the regulators remaining on staff have more work due to the cuts and no one to go to with questions since support staff were laid off. “The source said that reviewers who are tired, upset, and scared about their job security might not be as diligent in ‘a job that requires a lot of attention to detail,’” the paper reports. “I can’t imagine a less efficient approach than what the administration has already done,” the interviewee said.

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