US FDA Approves Neuralink’s First-in-human Clinical Trial

This approval comes after a long regulatory scrutiny that the Musk backed firm faced previously.
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Elon Musk’s brain-implant company Neuralink has been approved by the US Food and Drug Administration (FDA) for its first-in-human clinical trial. This approval comes after facing previous challenges in gaining regulatory clearance. While specific details about the study were not disclosed, Neuralink expressed that the FDA’s approval is an important initial step in their mission to use their technology to help many people. The company is expected to share more information about the trial in the near future.

Elon Musk envisions that the brain implants developed by Neuralink could potentially treat a range of conditions, including obesity, autism, depression, and schizophrenia. He also believes that the technology has the potential to enable web browsing and even telepathic communication. Musk’s confidence in the safety of the devices was demonstrated when he stated his willingness to implant them in his own children.

Neuralink had previously made several predictions since 2019 about commencing human trials but faced obstacles in obtaining FDA approval. Earlier this year, the FDA rejected the company’s application, expressing concerns about the lithium battery in the device, potential migration of the implant’s wires within the brain, and the safe extraction of the device without causing damage to brain tissue.

Neuralink, founded in 2016, has also faced scrutiny from federal investigations. US lawmakers called for regulators to investigate the company’s animal testing practices, raising questions about the oversight of the experiments. Additionally, the Department of Transportation is conducting a separate probe to determine if Neuralink transported dangerous pathogens on chips removed from monkey brains without proper containment measures. Furthermore, the US Department of Agriculture’s Office of Inspector General is investigating Neuralink for potential animal welfare violations and assessing the USDA’s oversight of the company.

Neuralink’s recent FDA approval for their first human clinical trial signifies a significant step forward in their mission to enable direct communication between brains and computers. The company aims to achieve this through implantable devices that allow individuals to interact with computers using their minds. Promising results have been demonstrated through tests on monkeys, where they were able to play video games using the Neuralink interface. While Neuralink’s progress is being closely watched, other companies like Synchron have also made advancements in the field of brain-machine interfaces, having successfully implanted the first such device in the United States earlier this year.

Conclusively, Neuralink’s FDA approval for its first human clinical trial is a major achievement for the company. The technology they are developing has the potential to revolutionise the field of brain-computer communication and may offer solutions for various medical conditions. However, Neuralink has faced regulatory challenges and scrutiny from federal investigations, which highlights the need for careful oversight and adherence to safety and ethical guidelines in the development and implementation of such groundbreaking technologies.

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Shyam Nandan Upadhyay
Shyam is a tech journalist with expertise in policy and politics, and exhibits a fervent interest in scrutinising the convergence of AI and analytics in society. In his leisure time, he indulges in anime binges and mountain hikes.

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