Yes, the FDA is allowing Elon Musk’s Neuralink to begin human trials

In late November 2022, billionaire Elon Musk said his company Neuralink was seeking permission from U.S. regulators to test its brain implant in people. 

The tech company is developing brain-computer interfaces (BCIs), which “allow people to control machines using their thoughts,” according to the Government Accountability Office (GAO). For example, the technology could help people with paralysis regain control of their limbs, the GAO says.

A viral post shared on X, formerly known as Twitter, on Sept. 20 claims Neuralink received approval from the U.S. Food and Drug Administration (FDA) to begin human trials. The post led to debates over the product and whether it should be allowed to be tested in people. 

THE QUESTION

Is the FDA allowing Neuralink to begin human trials?

THE SOURCES

• Neuralink
• U.S. Food and Drug Administration (FDA)

THE ANSWER

Yes, the FDA is allowing Neuralink to begin human trials. 

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WHAT WE FOUND

The FDA is allowing Neuralink to test its brain implant on humans. This doesn’t mean the device has received full FDA approval – that could only happen after the FDA reviews data from clinical trials. 

Neuralink announced on May 25, 2023, that the company received the FDA’s permission to launch its “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 technology to help many people,” the company said in a post on X.

More recently, Neuralink shared that it is recruiting patients for the human clinical trial. The company said in a Sept. 19 blog post that its Precise Robotically Implanted Brain-Computer Interface, or PRIME, study also received approval from an independent institutional review board and its first hospital site.

Clinical studies of “significant risk devices” like implants require prior approval from both the FDA and an Institutional Review Board (IRB), the FDA says on its website. 

The FDA allows clinical studies to move forward after it has received and approved an “investigational device exemption” (IDE) application. Neuralink said in its blog post that the FDA awarded the company an IDE in May 2023. 

An IDE allows an investigational device “to be used in a clinical study in order to collect safety and effectiveness data,” according to the FDA. 

This is not the same as full FDA approval of the device, which is a more lengthy process. After a device is tested on people to make sure it’s safe and effective, the FDA reviews data in order to make a decision on whether or not to approve it. 

While the FDA does not typically confirm approvals of human clinical trials, the agency provided a statement to VERIFY acknowledging Neuralink’s announcement. 

“The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption (IDE) for its study of its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device,” a spokesperson said.

Neuralink said its study aims to evaluate the safety and effectiveness of the company’s N1 brain implant and software, as well as a surgical robot. It will take approximately six years to complete, according to a study brochure. 

During the study, Neuralink’s R1 Robot will surgically place the implant “in a region of the brain that controls movement intention.” The implant is “cosmetically invisible” once it’s in place, and is “intended to record and transmit brain signals wirelessly to an app that decodes movement intention,” the company says. 

Neuralink is looking to recruit study participants who are at least 22 years old, and have either quadriplegia due to spinal cord injury or amyotrophic lateral sclerosis (ALS).

“The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone,” Neuralink said in its blog post. 

Musk said in a Sept. 20 post on X that the Neuralink device “ultimately has the potential to restore full body movement.” 

Neuralink has faced criticism from animal rights groups about how it tests its products. 

A nonprofit group, the Physicians Committee for Responsible Medicine, which among other causes advocates against animal testing, has lodged multiple complaints involving Neuralink and its treatment of monkeys and other animal subjects.

The company did admit in a February 2022 blog post that some monkeys have died during animal testing.