Devices

Rep. Questions Musk Device Trial OK Before Inspection

Rep. Earl Blumenauer (D-OR) is asking FDA why it did not inspect Elon Musk’s Neuralink facility before approving human trials of its medical device, a brain-computer interface. Reuters reports Blumenauer said he was concerned that the agency ignored “troubling evidence” of animal testing violations that had been raised as far back as at least 2019.

The news service says the representative cited Reuters reports on animal experiments in his letter to FDA, asking the agency to explain how it reconciled reports of animal testing lapses with the decision to authorize a human trial.

“These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials,” Blumenauer wrote, according to the article.

In response to a Reuters request for comment, an FDA spokesperson said the agency would respond to the lawmaker directly. The spokesperson also said the agency routinely carries out inspections after a human trial is approved, and said the Neuralink inspection did not find violations that would undermine the trial’s safety. Reuters reported in February that FDA inspectors found problems with record-keeping and quality controls for animal experiments at Neuralink in 6/2023, less than a month after the startup said it was cleared to test its brain implant in humans.

Neuralink says its “brain-computer interface is fully implantable, cosmetically invisible, and designed to let [patients with traumatic injuries] control a computer or mobile device anywhere [they] go,” using only their thoughts.

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

Read more

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