Elon Musk's company gets permission to test implanting chips into human brains

Neuralink, Elon Musk's brain chip implant company, claims to have received approval from the US Food and Drug Administration (FDA) for its first human clinical trial.

Neuralink, which was founded in 2016, said in a statement that this is the first step that “will one day enable our technology to help many people.”

“Recruitment has not yet begun for our clinical trial,” Musk’s company added on Twitter, promising more information in the coming days.

Billionaire entrepreneur Elon Musk predicted last December that Neuralink would receive regulatory approval in the first half of this year. And he was right, although the approval process was not easy and was rejected last year.

Neuralink has been raising expectations for its products for several years now. In 2020, Musk claimed in a presentation that the company’s chips would be able to cure diseases like paralysis and insomnia. He added that Neuralink chips could even give users “superhuman” vision. At the time, the company demonstrated its first brain chip implants on pigs.

In 2021, Neuralink representatives gave one of their most viral presentations yet. A monkey named Pager sat in front of a television and watched intently what was happening on the screen—a video game called Pong. The primate controlled its movements with just its eyes, thanks to a semiconductor device the size of a quarter that was implanted in both hemispheres of its brain.

Elon Musk has repeatedly boasted since 2019 that he was seeking FDA approval for human clinical trials. But company officials won’t apply to the regulator until 2022. According to Reuters, Neuralink’s first application was rejected by the FDA shortly after it was submitted. The agency reportedly raised concerns about “the device’s lithium battery, the risk of the implant’s wires migrating in the brain, and the challenge of safely removing the device without damaging brain tissue.”

According to a Reuters special report from March, some Neuralink employees expressed doubts that Neuralink could quickly overcome the issues that the FDA had raised. Kip Ludwig, former director of the neural engineering program at the US National Institutes of Health (NIH), told Reuters that “Neuralink does not appear to have the mindset and experience needed to bring this product to market quickly.”

Neuralink isn’t the only company preparing to conduct human clinical trials of brain implants. One of its main competitors, Paradromics, is also seeking FDA approval.

Founded in 2015, the Austin, Texas-based neurotech startup has made great strides with its implantable device. Their product, called Connexus Direct Data, is described as a communication device that can assist patients who have lost the ability to speak or type. The technology is so promising that the FDA has awarded Paradromics a “Breakthrough Device” designation, a program that allows 32 applications to undergo accelerated approval because they could benefit patients in their treatment and diagnosis.

Another company entering the nascent brain-computer interface (BCI) industry is Synchron.

These companies offer products that vary in size, weight, and performance of semiconductors, as well as the surgical methods for implanting them into the human brain. But they are all equally optimistic about the future benefits they could bring to millions of people.

According to baotintuc.vn

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