After initially rejecting the application, the Food and Drug Administration (FDA) has now granted approval to the company.
Neuralink, Elon Musk’s company specializing in brain implants, announced that it has received approval from the US Food and Drug Administration (FDA) to commence its first clinical study involving human participants. This approval marks a significant milestone for Neuralink, following previous challenges in obtaining the necessary clearance.
Since 2019, Musk has made several predictions about initiating human trials for Neuralink’s brain implant, which aims to address severe conditions such as paralysis and blindness. However, the company, established in 2016, only applied for FDA approval in early 2022, and the application was initially rejected, according to information provided by seven current and former employees to Reuters in March.
The FDA had raised multiple concerns that Neuralink needed to address before granting approval for human trials. These concerns included the lithium battery used in the device, the potential migration of the implant’s wires within the brain, and the challenge of safely removing the device without causing damage to brain tissue.
While the FDA approval is a significant development, US lawmakers are urging regulators to investigate whether the composition of the panel overseeing animal testing at Neuralink contributed to flawed and rushed experiments. Neuralink has already been the subject of federal investigations, with the US Department of Agriculture’s inspector general conducting an inquiry into potential violations of the Animal Welfare Act. The investigation was initiated in response to a federal prosecutor’s request, and it was revealed that the company had conducted experiments resulting in the deaths of around 1,500 animals, including sheep, pigs, and monkeys, since 2018.
In a recent tweet, Neuralink clarified that it is not yet open for a clinical trial despite receiving FDA approval. The company expressed gratitude to the FDA and emphasized that this approval represents an important initial step toward the eventual utilization of its technology to assist numerous individuals.
Elon Musk has consistently outlined an ambitious vision for Neuralink, envisioning a future where both disabled and healthy individuals can quickly receive surgical implants at local centers. These implants aim to address various conditions, ranging from obesity, autism, depression, and schizophrenia, to enabling capabilities like web browsing and telepathy.
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