The FDA gives Elon Musk's Neuralink permission to put brain implants in humans
After initially rejecting the applicationBy Rob Thubron 27 comments
What just happened? Neuralink, the brain-implant company founded by Elon Musk in 2016, has been given permission by the Federal Drug Administration (FDA) to begin its first in-human clinical study, paving the way for a brain-machine interface with the potential to treat fatal neurological diseases, paralysis, blindness, and more. The implant could also be used to control everyday devices with the mind.
Musk has on several occasions said that Neuralink was getting closer to starting human trials that will see a device implanted in a human brain.
We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study!– Neuralink (@neuralink) May 25, 2023
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
Neuralink applied for FDA approval in early 2022 but the agency rejected it over several concerns. Reuters writes that these included issues with the lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.
In 2021, Neuralink released a video of a macaque, which had one of the company's implants in its brain, playing Pong just by thinking about it. As the monkey played, the Neuralink recorded neuron activity. The data was used to determine which regions of the monkey's brain were firing when specific hand actions were carried out. Once the patterns were learned, the joystick was disconnected, but the monkey was still able to control the cursor because he was thinking about the movements.
But the experiments on monkeys led to accusations from the non-profit organization Physicians Committee for Responsible Medicine (PCRM) of animal abuse. The PCRM said the monkeys "had their brains mutilated in shoddy experiments and were left to suffer and die." Neuralink has reportedly killed about 1,500 animals since experiments began in 2018.
US lawmakers are now urging regulators to investigate how Neuralink oversees animal testing and whether the make-up of a panel overseeing these tests contributed to botched and rushed experiments.
Additionally, the PCRM accused Neuralink of violating federal laws relating to transporting hazardous material on multiple occasions. The Department of Transportation is investigating whether the company transported dangerous pathogens on the chips removed from the monkeys' brains.
Neuralink isn't the only brain interface company. New York-based Synchron received FDA approval for human trials in 2021. It carried out the first implant in July, and in December, a 62-year-old paralyzed Australian man who suffers from amyotrophic lateral sclerosis (ALS) used one of its implants to send a tweet just by thinking about it.
It's likely that people with similar conditions will sign up for Neuralink's trials. Musk himself said he plans to have one of the devices implanted into his own body at some point in the future, perhaps so he can stream music directly to his brain.