Devices

FDA Warns of Cybersecurity Risk with St. Jude Devices

FDA has identified cybersecurity vulnerabilities with St. Jude Medical’s implantable cardiac devices and its Merlin@home Transmitter. If exploited, the vulnerability could allow an unauthorized user to remotely access a patient’s radio frequency (RF)-enabled implanted cardiac device by altering the Merlin@home Transmitter, an agency safety alert says. “The altered Merlin@home Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion and/or administration of inappropriate pacing or shocks,” it says. So far, no injury reports related to this have been received.

To fix the problem, St Jude has developed and validated a software patch for the transmitter that addresses and reduces the risk of specific cybersecurity vulnerabilities. “Patients and patient caregivers only need to make sure their Merlin@home Transmitter remains plugged in and connected to the Merlin.net network to receive the patch,” FDA says. The agency conducted an assessment of the benefits and risks of using the Merlin@home Transmitter, and has determined that the health benefits to patients from continued use of the device outweigh the cybersecurity risks.

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