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Neuralink Received FDA’s Approval for a First-in-Human Clinical Study


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Neuralink Gains FDA Approval: Paving the Way for Revolutionary Brain-Implant Technology

Neuralink, Elon Musk’s brain-implant company, has received approval from the U.S. Food and Drug Administration (FDA) to conduct its first-in-human clinical trial. This significant milestone comes after the company faced previous struggles in obtaining approval.

Neuralink expressed its excitement about the FDA’s approval, acknowledging that it marks an important initial step toward utilizing its technology to benefit many individuals. While the company did not disclose specific details about the study or commence recruitment, it assured that more information would be provided soon.

Musk envisions brain implants as a potential cure for various conditions, including obesity, autism, depression, schizophrenia, and even capabilities like web browsing and telepathy. Last year, Musk made headlines when he confidently stated his willingness to have the implants placed in his own children, emphasizing his belief in their safety.

Despite previous claims that Neuralink would begin human trials, the company only sought FDA approval in early 2022. According to current and former employees, the FDA raised concerns about the lithium battery, the potential migration of implant wires within the brain, and the safe extraction of the device without causing damage to brain tissue. Addressing these issues was crucial before the FDA would sanction human trials.

Established in 2016, Neuralink has faced scrutiny from federal probes. Lawmakers urged regulators in May to investigate the composition of the panel overseeing animal testing at Neuralink, questioning whether it contributed to mishandled experiments. The Department of Transportation is conducting a separate probe to determine if Neuralink unlawfully transported hazardous pathogens on chips extracted from monkey brains without proper containment measures.

Moreover, the U.S. Department of Agriculture’s Office of Inspector General is investigating Neuralink for potential animal-welfare violations, examining both Neuralink’s conduct and the USDA’s oversight of the company.

Neuralink’s receipt of FDA approval for its first-in-human clinical trial is significant. The company’s ambitious vision for brain implants has the potential to revolutionize medical treatments and human capabilities. As further details emerge about the upcoming study, anticipation grows for the future impact of Neuralink’s groundbreaking technology on people’s lives.