Neuralink Gets FDA Approval To Start Clinical Trials
According to the company’s announcement on Thursday 25 May, Neuralink, led by Elon Musk, has obtained FDA approval to commence its “first-in-human clinical study.” This significant milestone brings the company closer to its goal of creating a direct connection between the human brain and computers.
Following the announcement, Elon Musk, one of the co-founders of Neuralink, expressed his response by congratulating the team through a tweet.
Neuralink, brain-computer interface employs numerous minuscule electrodes that are implanted in the brain to capture signals emitted by neurons and transmit them to a computer.
Significant Background Information
The approval timing aligns with Elon Musk’s previous statements at Neuralink’s recent event in December, where he mentioned that the company would be capable of implanting its initial brain chip in a human within six months. During the event, Musk and the Neuralink team demonstrated the functionality of the brain chips on monkeys and pigs.
Musk also highlighted potential real-world applications of the chips, such as restoring vision for individuals with visual impairment or improving motor function for people with paralysis. While these applications were discussed, Musk’s ultimate vision for Neuralink involves creating brain chips that enable direct interaction and eventual integration of human intelligence with artificial intelligence.
In March, Reuters published a report stating that the FDA had denied a previous application by the company to obtain approval for human trials in 2022. The agency had expressed concerns about the safety of the brain implants, specifically focusing on issues related to the lithium batteries, the possibility of the small wires migrating to other areas of the brain, and the company’s ability to safely remove the device without causing damage to the brain.
What We Don’t Know
The impact of this approval on an ongoing federal investigation into the company’s alleged violations of the Animal Welfare Act remains uncertain. The investigation, reportedly conducted by the U.S. Department of Agriculture’s (USDA) Inspector General, is in response to accusations that the company has caused the deaths of approximately 1,500 animals, including around 300 sheep, pigs, and monkeys, since 2018.
According to employees, the number of casualties could have been lower if not for Musk’s demands for quicker outcomes. Neuralink has consistently denied any allegations of animal cruelty, emphasizing its dedication to animal welfare. The company stated that its facilities and animal care programs have never been cited by the USDA.