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HomeTechnology NewsHuman Trials for Brain Chip Implants Set to Begin

Human Trials for Brain Chip Implants Set to Begin

Elon Musk made an announcement during the VivaTech event in Paris that his brain-chip start-up, Neuralink, is preparing to conduct its first human trial later this year. The trial will involve implanting the brain chip in a tetraplegic or paraplegic patient.

While specific details about the trial were not provided, Musk mentioned that the first case is expected to occur soon. This development comes after Neuralink recently obtained clearance from the US Food and Drug Administration (FDA) for its first-in-human clinical trial.

Obtaining Permission for Human Trials

Neuralink faced significant challenges in obtaining permission for human trials. Last month, the company received regulatory approval from the FDA, which was crucial for advancing its research.

However, Neuralink is also under investigation in the United States due to concerns regarding its handling of animal experiments.

Although the FDA granted permission for the use of Neuralink’s brain implant and surgical robot for the trials, specific details about the approval were not disclosed.

It should be noted that even if Neuralink can demonstrate the safety of its device in human subjects, it will still require several years, possibly more than a decade, to obtain commercial-use clearance.

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The company faces competition from other neurotech companies that have already implanted similar devices in humans. Moreover, Musk has previously missed timelines for Neuralink’s milestones, having made several public announcements since 2019 about the imminent commencement of human trials.

Neuralink’s Troubles with the Law

Established in 2016, Neuralink initially sought FDA approval in early 2022 but had its application rejected due to multiple safety concerns.

The FDA raised issues concerning the lithium battery of the device, the potential migration of the implant’s wires within the brain, and the challenge of safely extracting the device without causing damage to brain tissue.

Neuralink has also faced federal scrutiny following reports about its animal experiments. Employees expressed concerns about the company’s rushed and mishandled surgeries on animals such as monkeys, pigs, and sheep.

These rushed procedures resulted in unnecessary animal deaths, allegedly due to pressure from Elon Musk to obtain FDA approval. The purpose of these animal experiments was to gather data supporting Neuralink’s application for human trials.

A specific incident in 2021 involved the incorrect implantation of devices in 25 out of 60 pigs, leading to the euthanization of all affected pigs. Employees believe that better preparation could have prevented this error.

Following reports on potential financial conflicts within Neuralink’s animal testing oversight panel, US lawmakers called for an investigation into the matter to determine if these conflicts contributed to the company’s rushed and flawed experiments.

The US Department of Transportation is conducting a separate investigation into whether Neuralink violated regulations by transporting hazardous pathogens on chips removed from monkey brains without proper containment measures.

The US Department of Agriculture’s Office of Inspector General is also investigating Neuralink for possible violations of animal welfare regulations, specifically focusing on the USDA’s oversight of Neuralink’s activities.

Continued Growth and Valuation

Despite the investigations and controversies surrounding Neuralink, the company’s valuation has significantly increased in recent months. Two years ago, Neuralink was valued at approximately $2 billion in a private fundraising round. However, based on privately executed stock trades, the company is now estimated to be worth around $5 billion.

Some Neuralink employees, who were part of the company’s animal board and faced scrutiny for potential financial conflicts, have seen the value of their Neuralink stock rise by approximately 150% over a two-year period in secondary trades.

Conclusion

Neuralink’s announcement regarding the upcoming human trial for its brain chip implants marks a significant step forward in the company’s progress. Despite challenges and investigations, Neuralink has obtained regulatory clearance and is preparing to test its innovative technology on humans.

The outcome of these trials and the successful demonstration of the device’s safety will pave the way for future commercial use. As Neuralink continues to advance the field of brain-computer interfaces, it remains at the forefront of neurotechnology, even as it navigates the legal and ethical complexities surrounding its research.

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