Devices

FDA Finds Lab Issues at Musk Plant

Responding to concerns raised by Rep. Earl Blumenauer (D-OR), who has focused on animal welfare in medical product trials, FDA has advised Congress that in a 6/2023 inspection, the agency found “objectionable conditions” at an animal testing laboratory at Elon Musk’s Neuralink company. Reuters reports that the inspection of the animal lab occurred several weeks after FDA greenlighted a small study of Neuralink’s brain implant technology in humans.

The news service says FDA told Blumenauer that the issues it found warranted voluntary remediation by the company. They were not considered severe enough to warrant regulatory action, it says.

“While the company did receive citations related to documentation of its animal research, FDA’s inspection did not find evidence of any violations that would undermine the device’s safety,” FDA said in a statement in response to questions from Reuters. It gave no further details on the violations to the news service.

According to Reuters, Neuralink did not respond to its request for comment about whether it had fixed any of the problems identified by FDA. It told Reuters that it goes above and beyond existing regulations in its treatment of animals for testing.

A spokesperson for Blumenauer declined to comment.

Reuters says it also reported in 2022 about internal Neuralink staff complaints that the company rushed experiments, causing the needless suffering and death of pigs, monkeys, and other animals.

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