Elon Musk's Neuralink Set to Implant First Brain Chip Case This Year, Marking a Significant Milestone.

SAN FRANCISCO, June 16 : Renowned billionaire entrepreneur Elon Musk announced during his visit to France on Friday that he anticipates the initiation of the first human trial for his brain-chip startup, Neuralink, to take place this year.

During his speech at the VivaTech event held in Paris, co-founder Elon Musk unveiled Neuralink's intention to conduct a groundbreaking webcast in collaboration with Reuters, where they plan to demonstrate the implantation of their neural interface technology in a tetraplegic or paraplegic patient. While the specific number of patients and duration of the trials were not disclosed, Musk confidently stated that the highly anticipated first case is likely to take place later this year. Notably, Musk, who also serves as the CEO of Tesla, Twitter, and SpaceX, is renowned for his innovative contributions in the fields of electric vehicles, social media, and space exploration.

Neuralink, the brain-chip startup founded by Elon Musk, achieved a significant breakthrough last month with the announcement of receiving clearance from the U.S. Food and Drug Administration (FDA) for its inaugural clinical trial involving human subjects. This milestone holds immense importance for the company, especially in light of ongoing investigations by U.S. authorities regarding its handling of animal experiments. While the FDA confirmed its approval for Neuralink's employment of its brain implant and surgical robot in the upcoming trials, specific details were not disclosed as per the agency's statement to Reuters. Nonetheless, this regulatory clearance represents a significant step forward for Neuralink's pioneering efforts in the field of neurotechnology.

Neuralink's path to obtaining commercial use clearance for its brain-chip device hinges on successfully demonstrating its safety in human trials. Experts, who were previously interviewed by Reuters, have suggested that even if the device proves to be safe, it could still take several years, possibly more than a decade, for the start-up to navigate the regulatory processes and secure the necessary approvals. Furthermore, Neuralink faces competition from other neurotechnology companies that have already made progress by implanting their own devices in human subjects. The race to establish the viability and marketability of neurotech solutions is intensifying, adding to the challenges faced by Neuralink in its pursuit of widespread commercial application.

Despite previous public pronouncements by Elon Musk, the CEO of Neuralink, about the imminent commencement of human trials, the company has experienced delays in meeting those timelines. Since 2019, Musk has made approximately four predictions regarding the near-term initiation of human trials for Neuralink. However, these timelines have not been realized as anticipated. It is important to note that developing groundbreaking technology, such as brain-chip implants, involves complex challenges and unforeseen obstacles, which can contribute to delays in meeting projected timelines.

According to a Reuters report, the company, established in 2016, initially applied for FDA approval in early 2022. However, the application was denied by the agency due to numerous safety concerns. These concerns included issues related to the device's lithium battery, potential migration of the implant's wires within the brain, and the difficulty of extracting the device without causing damage to brain tissue.

Neuralink is under federal scrutiny in light of recent reports by Reuters regarding its animal experiments.

According to Reuters, Neuralink employees reported that the company conducted hurried and flawed surgeries on monkeys, pigs, and sheep last year, leading to avoidable animal fatalities. It was alleged that Elon Musk exerted pressure on the staff to obtain FDA approval. Sources indicated that the purpose of these animal experiments was to gather data in support of Neuralink's application for human trials.

Employees have reported that in 2021, the company implanted devices of incorrect sizes in 25 out of 60 pigs, leading to the subsequent euthanization of all the animals. These employees stated that with better preparation, such an error could have been easily prevented.

In May, lawmakers in the United States urged regulatory authorities to initiate an investigation into Neuralink. This request came after Reuters published a report highlighting potential financial conflicts among the members of Neuralink's board responsible for overseeing animal testing. The lawmakers were concerned that these conflicts may have contributed to the mishandled and hurried experiments.

The Department of Transportation is conducting a separate investigation into allegations that Neuralink unlawfully transported hazardous pathogens on chips extracted from monkey brains without adequate containment protocols. According to an agency spokesperson, the investigation remains ongoing as of Friday.

The U.S. Department of Agriculture's Office of Inspector General is currently investigating Neuralink for possible violations of animal welfare regulations. This probe specifically focuses on the USDA's oversight of Neuralink. At the time of this statement, an agency spokesperson has not yet responded to a request for comment.

the valuation of Neuralink has witnessed a significant increase in recent months. Two years ago, the start-up was valued close to $2 billion during a private fundraising round. Presently, based on privately executed stock trades, Neuralink's worth is estimated to be around $5 billion. The company's animal board, which is currently under federal scrutiny due to potential financial conflicts, involved employees who stood to benefit from the swift development of the implant. Reuters highlighted that the value of Neuralink stock held by these employees has surged by approximately 150% in just two years, based on secondary trades.

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