Devices

FDA Encouraging Device Security Updates

CDRH associate director for science and strategic partnerships Suzanne Schwartz says the agency is encouraging medical device manufacturers to proactively update and patch their devices in a safe and timely manner to address cybersecurity threats. Writing in an FDA Voice blog post, Schwartz says the “concept of updates and patches, while not new to traditional information technologies, is complex when it comes to critical safety systems and requires a collaborative approach to finding solutions.”

She notes that the agency has published guidances with recommendations for comprehensive management of medical device cybersecurity risks throughout the total product life cycle.

“FDA continues to work with manufacturers and the public to dispel myths about medical device cybersecurity,” Schwartz writes. “On our Web site is a printer-friendly fact sheet where we address some of the more prevalent myths concerning FDA and our role in helping to maintain the security of medical devices.”

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