Elon Musk’s Neuralink announced that the company has received approval from the Food and Drug Administration (FDA) to go ahead with its first in-human study. The neurotech startup, which is part of the brain-computer industry (BCI), received the approval on Thursday. Neuralink has built a brain implant device called the Link, and it is expected to be implanted in humans as the company has got approval.
Link is expected to help patients who suffer from severe paralysis and severe degenerative diseases. Neural signals could help such patients to communicate with family and friends by simple cursor movements and typing with the help of their minds.
The company announcement was posted on its site on social media. It mentioned the FDA approval but also said it would update recruitment for their clinical trial and other information soon.
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Neuralink has been applying for FDA approval for the past few years. Its last application was rejected in 2022 due to safety concerns about the implant. The brain chip maker seems to have addressed these complaints in the interim as it has been given the go-ahead for human clinical trials.
Our surgical robot uses advanced imaging systems to detect the brain and insert threads away from blood vessels. Here, you can see everything the robot sees while we test the accuracy of each of the robot’s high-precision cameras ? #techtuesday pic.twitter.com/c5rklTp2m4
— Neuralink (@neuralink) May 23, 2023
Elon Musk has been confident about his brain implant device for years. He even said that he would be willing to implant it in any family member’s brain, if it was necessary.
The brain-computer interface or BCI industry is an emerging industry. The system deciphers brain signals and converts them into commands for external technologies. Several companies have ventured into the brain-computer space, though Neuralink might be more familiar as it was founded by Elon Musk, who is the CEO of companies such as Tesla, SpaceX and Twitter.
The BCI system in Neuralink is based on the Link. The Link processes and translates neural signals. It has to be implanted into the brain using invasive brain surgery. Getting approval for in-human clinical studies from the FDA is the first step forward for Neuralink.
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Elon Musk is the father of twins with a Neuralink executive Shivon Zilis