Neuralink, the brain-implant company founded by Elon Musk, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) to commence its first-in-human clinical study. The approval granted to Neuralink signifies a significant milestone for the company, as it overcame previous hurdles encountered during the process of obtaining regulatory clearance.
Since 2019, Musk has made several predictions that his medical device company would initiate human trials for a brain implant designed to address severe conditions like paralysis and blindness. However, despite being founded in 2016, Neuralink only sought FDA approval in early 2022. In March, seven current and former employees revealed to Reuters that the agency had initially rejected the application, citing several concerns that needed to be addressed before authorizing human trials.
The FDA’s concerns, as communicated by the employees, revolved around issues such as the lithium battery of the device, the potential migration of implant wires within the brain, and the Ensuring the device can be safely removed without causing harm to brain tissue.
Coinciding with the FDA’s approval, US lawmakers are urging regulators to investigate the composition of a panel responsible for overseeing animal testing at Neuralink. There have been concerns that this panel may have contributed to rushed and flawed experiments conducted by the company. Neuralink has already been under scrutiny as federal investigations have been initiated. Last year, the US Department of Agriculture’s inspector general began an inquiry, prompted by a federal prosecutor’s request, to examine potential violations of the Animal Welfare Act. This act governs the treatment and testing of certain types of animals, and Reuters previously reported that Neuralink’s experiments resulted in the deaths of approximately 1,500 animals, including sheep, pigs, and monkeys since 2018. The investigation has also focused on the USDA’s oversight of Neuralink.
In a recent tweet, Neuralink clarified that it is not yet ready to proceed with clinical trials, despite the FDA approval. The company expressed gratitude for the collaborative efforts between the Neuralink team and the FDA, emphasizing that this milestone represents a significant first step towards realizing the potential of Their technology holds the promise of benefiting a multitude of individuals in the future.
Elon Musk has consistently outlined an ambitious vision for Neuralink, envisioning a future where both disabled and healthy individuals can readily receive surgical implants at local centers. These implants have the potential to target a diverse range of conditions, ranging from obesity, autism, depression, and schizophrenia, while also enabling extraordinary capabilities like web browsing and telepathy. Musk’s confidence in the safety of the device was evident when he publicly stated his willingness to have the implants placed in his children.
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While the FDA’s approval is a notable achievement for Neuralink, ongoing concerns and investigations surrounding the company’s practices underscore the importance of thorough evaluation and adherence to ethical standards in the field of neurotechnology.
