Devices

Illumina Cybersecurity Vulnerability: FDA

FDA says a cybersecurity vulnerability is affecting software in several Illumina next-generation sequencing instruments. An agency statement says the Illumina devices may be specified for either clinical diagnostic use in sequencing a person’s DNA or testing for various genetic conditions, or for research use only.

The notice says the vulnerability affects the local run manager software and an unauthorized user could exploit the vulnerability by:

taking control of the instrument remotely;
operating the system to alter settings, configurations, software, or data on the instrument or a customer’s network; or
affecting patient test results in the instruments intended for clinical diagnosis, including causing the instruments to provide no results or incorrect results, altered results, or a potential data breach.

FDA says Illumina has developed a software patch against the exploitation of the vulnerability and is working to provide a permanent software fix for current and future instruments. “FDA wants laboratory personnel and healthcare providers to be aware of the required actions to mitigate these cybersecurity risks,” 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