Neuralink, led by Elon Musk, receives FDA approval for human brain implant trials, marking a significant step towards addressing conditions and enhancing human capabilities.
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Neuralink, the brain-implant technology company led by Elon Musk, has achieved a significant milestone by obtaining approval from the US Food and Drug Administration (FDA) for its first-ever human clinical trial.
This groundbreaking decision allows Neuralink to move forward with testing brain implants on humans, paving the way for potential advancements in addressing various conditions and enhancing human capabilities.
The approval comes after a series of challenges Neuralink faces in its journey toward human trials.
FDA Approval and Neuralink’s Response
Neuralink expressed its enthusiasm about the FDA’s approval through a tweet, acknowledging the significance of this first step towards helping numerous individuals.
Although specific details about the study were not provided, Neuralink assured the public that more information would be available soon and that recruitment for the clinical trial had yet to begin.
Neither Neuralink nor the FDA have responded to Reuters’ requests for comment.
Elon Musk’s Vision and Previous Predictions
Elon Musk has been vocal about the potential of brain implants to address various conditions, such as obesity, autism, depression, and schizophrenia.
He even suggested that such technology could enable web browsing and telepathy. Last year, Musk garnered attention when he expressed confidence in the safety of the devices and stated his willingness to have them implanted in his children.
Delays and FDA Concerns
Despite Musk’s predictions of human trials starting in 2019, Neuralink only sought FDA approval in early 2022.
In March, seven current and former employees revealed that the FDA had raised concerns that needed to be addressed before approving human trials.
These concerns included the device’s lithium battery, the potential movement of implant wires within the brain, and the safe extraction of the device without causing harm to brain tissue.
Investigations and Regulatory Scrutiny
Neuralink has been under investigation by federal authorities since its establishment in 2016.
In May, US lawmakers urged regulators to examine the composition of a panel overseeing animal testing at Neuralink, raising concerns about rushed and problematic experiments.
Furthermore, the Department of Transportation investigates whether Neuralink unlawfully transported hazardous pathogens on chips extracted from monkey brains without proper containment measures.
Additionally, the US Department of Agriculture’s Office of Inspector General investigates potential animal-welfare violations at Neuralink and the USDA’s company oversight.
Neuralink’s achievement of FDA approval for human clinical trials represents a significant milestone for Elon Musk’s brain-implant technology company.
This breakthrough opens the door for potential advancements in addressing various conditions and enhancing human capabilities.
While the specific details of the trial remain undisclosed, Neuralink assures the public that further information will be forthcoming.
As the company prepares to embark on this revolutionary journey, it will face continued scrutiny from regulatory authorities investigating its practices and ensuring its technologies’ ethical and safe implementation.