Devices

Neuralink Says FDA OKs Brain Implant Trial

Neuralink, the neurotechnology company owned by Elon Musk, says it has gained FDA approval for a human clinical trial of its brain implant technology. The agency has not commented publicly on the reported approval or specified what it includes, according to a UPI report.

In March, Reuters reported it had been informed by multiple sources that FDA had rejected a human trial for the company, listing dozens of deficiencies that had to be resolved before any approval could be given. The sources said the primary concerns involved the device’s lithium battery, the potential for the implant’s tiny wires to migrate to other areas of the brain, and questions over whether and how the device could be removed without damaging brain tissue.

The company has been working since 2017 on its plan to implant electrodes into human brains to enhance their computer interface, the UPI report says. The project is geared to patients with severe paralysis so they might be able to control external technology through neural signals.

The company Web site says its goal is to “create a generalized brain interface to restore autonomy to those with unmet medical needs today and unlock human potential tomorrow.”

In 12/2022, the Physicians Committee for Responsible Medicine asked FDA to open an inquiry into Neuralink for possible violations of good laboratory practice regulations. The group said Neuralink was already facing Department of Agriculture and Department of Justice investigations.

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