Devices

FDA Explains Urgent/11 Cybersecurity Vulnerability

FDA is informing patients, healthcare professionals, IT staff in healthcare facilities, and manufacturers about the Urgent/11 cybersecurity vulnerabilities that, if exploited by a remote attacker, “may introduce risks for medical devices and hospital networks.” An online notice says that Urgent/11 affects several operating systems that may then affect certain medical devices connected to a communications network, such as wi-fi and public or home Internet, as well as other connected equipment such as routers, connected phones, and other critical infrastructure equipment.

“These cybersecurity vulnerabilities may allow a remote user to take control of a medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent a device from functioning properly or at all,” the agency notice says.

FDA says that to date it has not received any adverse event reports associated with the vulnerabilities. It says the Urgent/11 vulnerabilities exist in a third-party software called IPnet that computers use to communicate with each other over a network. “The agency is asking manufacturers to work with healthcare providers to determine which medical devices, either in their healthcare facility or used by their patients, could be affected by Urgent/11 and develop risk mitigation plans,” the notice says.

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