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Neuralink announces that it has obtained approval from the U.S. FDA to conduct a study on human brain implants.

by Swati Gupta

May 27, 2023 28

Neuralink, the brain-implant company led by Elon Musk, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its first-in-human clinical trial. This milestone approval comes after previous challenges in obtaining the necessary clearance.

In a tweet, the company stated that the FDA’s approval is a significant first step towards leveraging their technology to benefit many individuals. However, the company did not provide specific details about the study’s objectives, noting that they are not currently recruiting participants but will share more information soon.

Neither the company nor the FDA immediately responded to requests for comment from Reuters.

Elon Musk envisions that brain implants developed by the company could have transformative potential in treating various conditions, including obesity, autism, depression, schizophrenia, and even facilitating activities such as web browsing and telepathy. Musk garnered attention last year when he expressed confidence in the safety of the devices to the extent that he would be willing to implant them in his own children.

Since 2019, Musk has made multiple predictions about the company’s initiation of human trials. However, the company only recently sought FDA approval in early 2022, and as reported by seven current and former employees to Reuters in March, the agency initially rejected their application.

The FDA had raised several concerns that Neuralink needed to address before approving human trials. These concerns included issues related to the device’s lithium battery, the potential migration of the implant’s wires within the brain, and the safe extraction of the device without causing damage to brain tissue, according to the employees’ statements.

Established in 2016, Neuralink has faced scrutiny from various federal investigations. In May, US lawmakers urged regulators to examine whether the composition of a panel overseeing animal testing at Neuralink contributed to mishandled and rushed experiments. Additionally, the Department of Transportation is conducting a separate investigation into whether Neuralink violated regulations by transporting hazardous pathogens on chips extracted from monkey brains without proper containment measures.

Furthermore, the US Department of Agriculture’s Office of Inspector General is investigating Neuralink for potential violations related to animal welfare. This probe also encompasses the USDA’s oversight of Neuralink.

Neuralink has not yet commented on these investigations despite requests for clarification.

Neuralink, the brain-implant company founded by Elon Musk, has garnered further attention with its recent announcement of receiving approval from the US Food and Drug Administration (FDA) for its first-in-human clinical trial. This marks a significant milestone for Neuralink, especially considering the challenges it faced in obtaining approval in the past.

The FDA’s green light for the clinical trial was hailed by Neuralink as an important first step towards harnessing the potential of their technology to assist numerous individuals. While the company didn’t provide extensive details about the study’s objectives, it did clarify that it is not currently recruiting participants and that more information will be made available in due course.

Neither Neuralink nor the FDA has responded to requests for comment from Reuters regarding this development.

Elon Musk has long envisioned the transformative power of brain implants developed by Neuralink, with potential applications ranging from addressing conditions such as obesity, autism, depression, and schizophrenia to enabling unique capabilities like web browsing and telepathy. Musk’s bold belief in the safety of these devices was highlighted when he expressed his willingness to have them implanted in his own children.

As Neuralink progresses with its FDA-approved human clinical trial, the company remains at the forefront of innovative research and development in the field of brain-implant technology. The outcome of these trials will shed light on the potential applications and impact of Neuralink’s groundbreaking advancements in neuroscience.