Neuralink has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to begin human clinical trials.
Since its establishment in 2016, billionaire Elon Musk has repeatedly claimed that the technology developed by his company will “revolutionize” the healthcare industry. (Photo: Reuters).
On May 26, the neural research company Neuralink, founded by billionaire Elon Musk, announced that it has received FDA approval to conduct its first human clinical trial.
This announcement comes exactly six months after Musk stated in November 2022 that Neuralink would only need about six more months before it could start human testing.
This is a significant milestone for Neuralink, setting the stage for future research by the company.
Currently, it is difficult to determine who will be the first to take on this responsibility. It could be a patient with neurological issues, an enthusiastic “fan” wanting to attract Elon Musk’s attention, or even Musk himself.
The company founded by billionaire Elon Musk has previously been investigated for animal cruelty. (Photo: Neuralink).
Musk has also claimed that he plans to implant this device in his own brain at an unspecified time in the future.
Before receiving approval, Neuralink’s plans to test brain chip implants on disabled individuals had to undergo multiple adjustments to satisfy regulators.
At the beginning of 2022, the FDA rejected the company’s application. In explaining its decision, the FDA cited several major issues that Neuralink needed to address before proceeding with human trials.
The primary safety concerns from the agency included the lithium battery of the device, the potential for the small wires of the implant to move to other areas of the brain, and questions about how to remove the device without damaging brain tissue.
Previously, Neuralink was also accused of mistreating animal test subjects, primarily monkeys. The company was subsequently investigated for allegations of transporting contaminated devices taken from monkeys.
Notably, Neuralink is not the first company to implant chips into the human brain. The company Synchron, which specializes in developing neural technology solutions, received FDA approval to begin trials in the U.S. in 2021 and announced its first implantation in July 2022.
In January of this year, Synchron announced the results of a prior study involving four Australian patients.
