Elon Musk’s Neuralink has achieved a significant breakthrough by securing the endorsement of the U.S. Food and Drug Administration (FDA) for its first-ever clinical trial involving human participants. This clearance represents a significant achievement for the brain-implant startup, particularly considering the ongoing investigations by U.S. authorities into its handling of animal testing.
Neuralink capabilities
Elon Musk has a vision that brain implants developed by Neuralink could potentially offer cures for various conditions such as obesity, autism, depression, and schizophrenia. He holds the belief that these implants could grant individuals abilities such as web browsing and telepathy. His assertions regarding the safety of the devices and his expressed readiness to have them implanted in his own children garnered considerable media coverage.
Neuralink announced the FDA approval on Thursday through a tweet, expressing that it represents a crucial advancement towards harnessing their technology to help numerous individuals. Nevertheless, precise information regarding the study’s particulars was not revealed, and Neuralink clarified that they are not presently enlisting participants. They reassured me that additional details will be made available in the coming days.
Although the FDA acknowledged the clearance of Neuralink for conducting trials on patients with their brain implants and surgical robot, no additional details were disclosed. Queries seeking comments from Neuralink and Elon Musk regarding the FDA approval remained unanswered.
This noteworthy achievement for Neuralink arrives amidst scrutiny faced by the company following reports from Reuters about their animal experiments. According to the Reuters investigation, Neuralink employees alleged that surgeries on animals, including monkeys, pigs, and sheep, were rushed and mishandled, leading to avoidable deaths. The animal experiments were conducted to gather data in support of Neuralink’s application for human trials.
In one instance, 25 out of 60 pigs were implanted with incorrectly-sized devices, resulting in the subsequent euthanization of all the pigs involved. Employees claimed that proper preparation could have easily prevented this error.
In light of these concerns, U.S. legislators called upon regulators to examine the makeup of the committee responsible for overseeing animal testing at Neuralink, citing suspicions of potential conflicts of interest. Furthermore, the Department of Transportation launched a separate investigation to determine if Neuralink transported hazardous pathogens from monkey brains on chips without proper containment measures. Additionally, the U.S. Department of Agriculture’s Office of Inspector General is currently conducting an inquiry into potential violations of animal welfare regulations at Neuralink.
This probe focuses on the USDA’s oversight of the company and was launched due to rising employee concerns about rushed experiments leading to additional suffering and deaths of animals.
Initially, Neuralink had aimed to receive approval to implant its devices in 10 patients, but recent negotiations with the FDA resulted in a lower number due to safety concerns raised by the agency. The exact number of approved patients remains undisclosed.
Although Elon Musk had previously made predictions about Neuralink conducting human trials as early as 2019, the company did not actually submit an application for FDA approval until early 2022. However, their initial application was denied due to safety concerns. The FDA highlighted specific areas that needed to be resolved, including the safety of the lithium battery, potential wire migration within the brain, and ensuring the device’s removal without harming the surrounding brain tissue.
