Photo: Neuralink | Edited
Brain-implant company Neuralink might be the spookiest Elon Musk ever owned, considering its goal to turn humans into cyborgs. The company started testing on animals a while back and planned to begin human trials in 2023. Now, Neuralink announced that the US Food and Drug Administration (FDA) gave it the green light to start the first-in-human clinical trials.
Neuralink developed a brain-computer interface that could one day help disabled patients move and communicate again. Despite its huge ambitions, the company has been more famous for animal welfare controversies. That's because Neuralink does a lot of tests on animals before it can move to human trials. Last year, the US Department of Agriculture's Inspector General opened an investigation into Neuralink at a federal prosecutor's request. The federal probe was triggered by internal staff complaints that the animal testing was being rushed, causing needless suffering and deaths.
We have no idea how the investigation is going, but the company was in a rush to start human trials of its brain implant. This was something that Neuralink wanted to do for a long time, with deadlines announced for 2020 and then 2022. According to Reuters, Neuralink first submitted paperwork to the FDA in early 2022, but the agency rejected the application. The FDA was concerned about the device's lithium battery and the possibility of the implant's wires migrating within the brain. Another issue was extracting the device without damaging the brain tissue.
During last year's Show and Tell event, Elon Musk promised again that human trials would start in six months. Although no one thought the company's brain implant would be ready for human testing in 2023, Neuralink confirmed it's got the FDA's approval. The startup announced the breakthrough on Twitter as an essential first step that will one day allow the technology to help many people.
Those who want a chip implanted into their brains as soon as possible would have to wait a little longer, though. Neuralink has not yet started recruitment for the first clinical trials but will make an announcement on this "soon." So far, the extent of Neuralink's first-in-human clinical trial is unknown, but we expect it to be very limited.
Neuralink is developing a system that it calls "Link," a small circular implant that deciphers brain signals and translates them into commands for use with external devices. The Link comprises a series of thin, flexible threads inserted directly into the brain tissue, where they detect neural signals. A robotic system is used to implant the threads into the brain during a 15-minute operation. This requires the utmost precision, and the process needs to be repeated 64 times in a reasonable amount of time.
Although several companies are active in this field, Neuralink is the first to get FDA approval for human trials. This is a significant step for the company, especially after repeated investigations and controversies. Elon Musk has such high confidence in his company's technology that he plans to receive one of Neuralink's implants himself.
We have no idea how the investigation is going, but the company was in a rush to start human trials of its brain implant. This was something that Neuralink wanted to do for a long time, with deadlines announced for 2020 and then 2022. According to Reuters, Neuralink first submitted paperwork to the FDA in early 2022, but the agency rejected the application. The FDA was concerned about the device's lithium battery and the possibility of the implant's wires migrating within the brain. Another issue was extracting the device without damaging the brain tissue.
During last year's Show and Tell event, Elon Musk promised again that human trials would start in six months. Although no one thought the company's brain implant would be ready for human testing in 2023, Neuralink confirmed it's got the FDA's approval. The startup announced the breakthrough on Twitter as an essential first step that will one day allow the technology to help many people.
Those who want a chip implanted into their brains as soon as possible would have to wait a little longer, though. Neuralink has not yet started recruitment for the first clinical trials but will make an announcement on this "soon." So far, the extent of Neuralink's first-in-human clinical trial is unknown, but we expect it to be very limited.
Neuralink is developing a system that it calls "Link," a small circular implant that deciphers brain signals and translates them into commands for use with external devices. The Link comprises a series of thin, flexible threads inserted directly into the brain tissue, where they detect neural signals. A robotic system is used to implant the threads into the brain during a 15-minute operation. This requires the utmost precision, and the process needs to be repeated 64 times in a reasonable amount of time.
Although several companies are active in this field, Neuralink is the first to get FDA approval for human trials. This is a significant step for the company, especially after repeated investigations and controversies. Elon Musk has such high confidence in his company's technology that he plans to receive one of Neuralink's implants himself.
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…
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