Neuralink, Elon Musk's neurotechnology startup, on Thursday received approval from the U.S. Food and Drug Administration (FDA) to conduct the first clinical study to test brain implants in humans.
Neuralink is building an electronic chip or brain implant called Link, which aims to help paralyzed patients control external electronic devices using only nerve signals.
According to a report by the French, this technique is supposed to be used in the first stage to help people who are paralyzed or suffer from neurological diseases. But the long-term goal is to make these implants safe, reliable and simple, so simple that they will fall under elective (well-being) surgeries.
People will then be able to pay a few thousand dollars to equip their brains with information capabilities.
Speaking in a tweet on Thursday, Neuralink said in a tweet on Thursday, without disclosing details of the planned study, that the FDA's approval "represents an important first step that will one day allow our technology to help many people," adding that more details would be available soon.
In a statement, the Food and Drug Administration allowed Neuralink to use a brain implant and a surgical robot to conduct experiments on patients, but declined to provide further details, a Reuters report said.
We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study!
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 (@neuralink) May 25, 2023
Neuralink's achievement comes as the company faces federal scrutiny following Reuters reports of the company's animal testing.
Neuralink employees told Reuters last year that the company was carrying out surgeries on monkeys, pigs and sheep, resulting in too many animal deaths, as Elon Musk pressured employees to get approval from the Food and Drug Administration.
The sources said animal testing produced data aimed at supporting the company's application of human trials.
Victor Krauthammer, an assistant professor of biomedical engineering who has spent three decades at the U.S. Food and Drug Administration, including overseeing the office that reviews applications for human trials of brain transplants, said the FDA doesn't typically inspect operational facilities as part of its review of clinical trial applications, Reuters reported.
Neuralink is part of an emerging industry known as the Brain Computer Interface, a system that decodes brain signals and translates them into commands for external devices.
Neuralink is perhaps the most well-known name in the field thanks to Elon Musk, who is also CEO of electric car maker Tesla and space industries company SpaceX, among others.
Other companies are working on technology to control computers by thinking, including Syncron, which announced in July 2022 that it had implanted the first "brain-computer communication tool" in the United States.
Thomas Oxley, founder and president of the startup, said in a video on his website, "We are building technology that can broadcast the thoughts of people who have lost the ability to move or speak due to illness or injury."
Neuralink is the most popular name in the field of electronic brain implants (French)
Musk had predicted on at least four occasions since 4 that Neuralink would begin human trials, but with these optimistic statements, the company only sought FDA approval in early 2019, and the agency rejected the request, Reuters reported in March.
Reuters reported that the U.S. Food and Drug Administration cited several of Neuralink's safety concerns in its rejection report that must be addressed before human trials can be allowed.
Some of the problems included the device's lithium battery, the ability of the implant wires to move inside the brain, and the biggest challenge of safely extracting the device without damaging brain tissue.