Elon Musk’s brain implant business, Neuralink, announced Thursday night that it has received regulatory approval to carry out the first human clinical study for its experimental technology.
The U.S. Food and Drug Administration’s approval would be a significant step for the business, which has been working on a robot-assisted brain implantable device that can decode brain activity and transmit information to computers. The business has exclusively used animals for studies up until this point.
“We are happy to announce that the FDA has given us permission to begin our first-in-human clinical study.” On Twitter, Neuralink made the announcement and referred to it as “an important first step that will one day allow our technology to help many people.” Musk shared the article on Twitter and praised his group.
Requests for comment made late Thursday night were not immediately answered by the FDA or Neuralink.
Musk has previously overhyped governmental acceptance. He claimed on Twitter in 2017 that the underground Hyperloop from New York to DC has obtained “verbal govt approval” from his tunnelling company, The Boring Company. Musk’s claim was not directly confirmed by authorities at the time, and it was obvious that no formal steps to sanction such a project had been done.
Describing Neuralink
Privately owned since its founding in 2016, Neuralink has offices in Fremont, California, and a sizable campus that is still under development just outside of Austin. According to data provider PitchBook, the company has more than 400 workers and has raised at least $363 million.
The brain-computer interface sector, where scientists and engineers are working to create electronic implants that would decode brain activity and transmit it to computers, has received tremendous resources because to Musk’s support from Neuralink as well as investor attention. This long-in-development technology has the potential to help those with paralysis and crippling illnesses like amyotrophic lateral sclerosis regain function.
At least 42 people worldwide have already received brain-computer implants from businesses like Blackrock Neurotech and Synchron for clinical trials. These tools have made it possible for people with disabilities to perform actions that were previously only possible in science fiction. Examples include a paralysed man fist-bumping Barack Obama with a robotic hand, an ALS patient typing by imagining keystrokes, and a tetraplegic patient walking with a leisurely, natural stride.
While the majority of businesses looking to commercialise brain implants are concentrated on people with medical requirements, Neuralink has even greater goals: developing a tool that not only repairs but also improves human function.
Neuralink tweeted in April, “We want to surpass able-bodied human performance with our technology.”
What is the brain chip technology used by Neuralink?
The business has created a robotic surgery tool and an electrode-loaded computer chip that will be sewn onto the surface of the brain. Musk thinks that the technology might be updated frequently.
At a late November event, Musk said, “I’m pretty sure you would not want the iPhone 1 stuck in your head if the iPhone 14 is available. Neuralink will start human trials in six months.”
A clinical study for its product in humans is an important milestone, but it does not ensure regulatory or commercial success. In addition to dealing with the ethical and security issues brought up by a technology that could provide those with implants an advantage in cognition, Neuralink and others will undoubtedly be subjected to severe inspection by the FDA to ensure that their devices are safe and reliable.
When will human clinical studies start?
When clinical studies might start is unknown.
In a commercial empire that now includes generative artificial intelligence and social networking in addition to electric automobiles and rockets that carry people into space, Musk’s most audacious investment is the brain-computer interface.
Musk founded X.AI earlier this year in an effort to take on Microsoft and Google after the tech titans introduced expansive language-model chatbots that can respond to a wide range of questions.
In the meantime, he has been spending a lot of time lately on Twitter, the social media platform he bought last year for $44 billion with the promise of reestablishing “free speech.”
Musk juggles his obligations to all of the firms at once due to his hectic schedule. He uses a private jet to fly across the country, stopping at SpaceX launch sites, Tesla manufacturing, and Twitter’s Bay Area headquarters, sometimes all within the same week. Twitter CEO Linda Yaccarino was named by Elon Musk earlier this month, relieving Musk of some of the management duties for the social media platform, which has been in disarray since his takeover last year.