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Sunday, February 25, 2024

USA. Neuralink implants not approved for human trials before the FDA – failure of Elon Musk

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Elon Musk promised that his company Neuralink would create implants thanks to which the blind would regain their sight and the paralyzed would be able to walk again. However, so far it has not received approval from the US Food and Drug Administration for the simplest human clinical trials aimed at enabling people with disabilities to write.

From 2019 Elon Musk announced at least four times that Neuralink would soon start human trials so that their implants could help people with disabilities. However, in fact, the company only in early 2022 submitted its first application for authorization to the Food and Drug Administration (FDA). Seven former and current Neuralink employees reported to Reuters office rejected it.

So far, this information has not been disclosed. Both Neuralink and Musk did not respond to Reuters requests for comment on the matter. The agency itself declined to comment, citing regulations that ensure companies the right to privacy of commercial information.

The FDA has objections to Neuralink implants

The agency noted dozens of problemsthat Neuralink needs to solve before it can start human trials.

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– The main security concerns of the agency concerned device’s lithium battery; the possibility of the implant’s tiny wires migrating to other areas of the brain; and questions whether and how the device can be removed without damaging brain tissue employees interviewed by Reuters said.

A year has passed since the application was rejected, and Neuralink is still working on the comments made by the FDA.

Three Neuralink employees said they were skeptical the company could fix the issues quickly – despite Musk’s latest prediction at a November 30 presentation that the company would get FDA approval for human trials this spring.

Just because the FDA has now rejected Neuralink’s application doesn’t mean the company can’t try again. However, according to experts in the Agency’s device approval processes rejection is a signal of serious concern against the project.

“Neuralink doesn’t seem to have the mindset and experience needed to bring it to market any time soon,” Kip Ludwig, former neural engineering program director at the US National Institutes of Health, told Reuters. NIH) and added that everyone in the industry expected this development.

Without directly commenting on the Neuralink case, the FDA said in a response to the agency that it adheres to high standards for vetting all brain implants, even if it is to speed up reviews. “Innovation and security are not an either-or scenariosaid Owen Faris, who helps oversee the FDA’s Office of Product Evaluation and Quality. The two must go hand in hand.

Musk’s promises and reality

During his speeches, Elon Musk has repeatedly talked about what a revolutionary solution the Neuralink implant is supposed to be. He promised to restore sight to the blind, mobility to the paralyzed, and even talked about things like “scrolling through your own memories.”

However, as Reuters notes, in February Dongjin “DJ” Seo, Neuralink’s vice president of engineering, told a conference that the “major short-term goal” was more modest: to help paralyzed patients communicate via computerized text without writing. Seo said that full mobility along with restoring sight to the blind are “long-term goals“.

– He can’t understand that it’s not a car. This is the human brain. This is not a toy – a former Neuralink employee told Reuters about Musk’s approach to implants.

FDA investigation into monkey testing

Neuralink’s focus on delivering a solution as quickly as possible has led to several problems.

In the foreground is the investigation conducted at the federal level whether the experiments carried out on pigs, sheep and monkeys were not cruel.

Three Neuralink employees have now told Reuters that company leaders wanted to speed up animal experimentation to gather the data needed to address FDA concerns about human research applications.

In addition, the U.S. Department of Transportation recently launched an investigation into whether Neuralink broke the law by handling the removal of chips from monkey brains without proper safeguards.

“We are conducting an investigation to ensure Neuralink is fully compliant with federal regulations and is protecting its employees and the public from potentially dangerous pathogens,” a department spokesman said on February 9, as news of the investigation emerged.

Main photo source: Getty Images North America



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