Neuralink Receives US FDA Approval for Human Trials

Neuralink Receives US FDA Approval for Human Trials
Neuralink Receives US FDA Approval for Human Trials

Based in Fremont, California, the Neuralink Corporation is an American company that specializes in neurotechnology and is creating implantable brain-computer interfaces (BCIs). Founded by Elon Musk and a team of seven scientists and engineers, Neuralink was developed in 2016 and was first publicly disclosed in March 2017.

The goal of Neuralink's research is to create an AI chip that could be placed in a person's skull and have electrodes that extend into their brain. These electrodes could track and even stimulate brain activity.

Its initial application entails enabling quadriplegics to operate digital devices with their minds.

As sewing machines, these robots will stitch these strands into the human brain. These threads, intended to be inserted deeply into a person's brain tissue, are relatively thin (4 to 6 μm), or around one-third the diameter of the most delicate human hair. It will be able to execute both read and write operations at very high data volumes if everything proceeds exactly as planned.

In a private fundraising round two years ago, Neuralink was valued at around $2 Bn. According to privately executed stock trades that five sources with knowledge of the situation described to Reuters, Neuralink is now worth about $5 Bn.

Instead of Neuralink issuing additional shares to investors, the stock transactions at a valuation of almost $5 Bn have been carried out by stockholders like employees and the company's early backers. These so-called secondary trades lack the wider market consensus of a fundraising round or initial public offering (IPO), have a low volume, and are therefore a poor indicator of a company's value.

According to data provider Pitchbook, Neuralink raised $205 Mn in its final known funding in 2021 at a roughly $2 Bn valuation.

Based on the secondary trades, the value of the Neuralink stock that some of the employees own has increased by almost 150% in just two years.

According to Cristin Welle, a neurophysiologist at the University of Colorado, the company's device uses "ultra-flexible, tiny electrodes implanted directly into the brain tissue to 'listen' to the communication between neurons," which could enable users to communicate or operate other devices by simply thinking.

What Musk has to say about it?

According to Musk, the Neuralink device might be used to cure various medical ailments, including depression, paralysis, and blindness. However, he has also stated that the ultimate goal is to develop a "general population device" that would enable users to connect their minds directly to supercomputers and keep up with artificial intelligence. Additionally, he has said that in the future, the gadget might be able to extract and save thoughts, acting as "a backup drive for your non-physical being, your digital soul." According to him, he started the business mostly in reaction to worries that artificial intelligence will have too much influence over people. According to Musk, who claimed that the Neuralink gadget would enable humans to compete with future sentient AI, "I created (Neuralink) specifically to address the AI symbiosis problem, which I think is an existential threat."

Musk has stated that Neuralink's chip will enable healthy and disabled people to go into nearby facilities for quick surgical insertions of devices to cure obesity, autism, depression, and schizophrenia. Musk has stated that Neuralink has big goals. He even observes them being used for telepathy and web browsing. More modest short-term goals, such as assisting individuals with paralysis to converse through computerized text without typing, were recently stated by a Neuralink executive.

He is developing what is referred to as the "Link," a kind of brain chip, which can communicate directly with the human brain. According to Musk, it is a "Fitbit in your skull" that can be autonomously implanted by a robot that functions like a neural sewing machine.

Neuralink Receives FDA Approval for Human Testing

US Food and Drug Administration (FDA) has granted Neuralink's request to conduct its initial human studies. In 2019, Neuralink revealed how the Neuralink implant may be used to play "Pong" on a monkey. The business won recognition for developing wireless technology that has the potential to be used to create neural networks capable of carrying out complex tasks. Taking to Twitter, the official handle of Neuralink posted, “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 technology to help many people. Recruitment is not yet open for our clinical trial. We'll announce more information on this soon”.

What competitors of Neuralink have achieved in the field?

The market for "neuromodulation devices," which monitor or stimulate brain activity, is already worth more than $6 Bn. Rival company Synchron is developing similar technology, however, it enters the brain through blood veins rather than being implanted inside the skull. It has beaten Neuralink to human trials. It received the green light for human testing from the Federal Drug Administration in July 2021, and announced it implanted its first device into a US patient, a man with amyotrophic lateral sclerosis – a neurodegenerative disease also known as Lou Gehrig's disease – had used the device implanted in his brain to send a Tweet that said: "Hello World."

Blackrock Neurotech has been conducting human experiments for more than ten years, implanting brain implants that allow paralyzed persons to manage digital devices and prosthetics.

Brain implants for diseases like Parkinson's disease are already widely used, and similar companies began conducting human studies decades ago; Neuralink is not the only company undertaking this or even the most advanced.


  • Animal Cruelty Allegations: In 2022, the Physicians Committee for Responsible Medicine (PCRM) lodged a grievance with the U.S. Department of Agriculture (USDA), stating that Neuralink had broken the law when it came to animal experimentation. In the case, Neuralink was charged with torturing monkeys needlessly, including by implanting brain chips without anesthesia and carving holes in their skulls.
  • Reaction from the Public: Neuralink faced criticism from the public after charges of animal mistreatment were made. Some people demanded a boycott of Neuralink, while others voiced doubts regarding the morality of BCI (brain-computer interface) research and showed concerns regarding the data stealing and privacy of the people.
  • Regulation Obstacles: The USDA is still looking at Neuralink's animal experiments. Neuralink may be subject to fines or other sanctions if the USDA determines that the corporation broke animal welfare rules. The probe may potentially cause Neuralink to postpone its ambitions to test its BCI technology on humans.

Neuralink has defended its use of animals in testing, claiming that the company complies with all relevant laws and rules. The business has also stated its commitment to treating animals ethically.

One of the things that can slow down the advancement of BCI technology is the difficulties presented by animal experimentation. However, Neuralink and other businesses are attempting to provide new, less invasive, and more compassionate ways to test animals. If these techniques are effective, they may assist to lessen ethical worries regarding BCI research and make it simpler for businesses to carry out human trials.


The project Neuralink is ambitious and has the potential to completely change how we interact with the world around us. It functions in a unique manner where a robot physically implants a device into the brain and this device can connect signals from the brain to computers and other machinery and decipher some brain activity. For instance, persons who are paralyzed below the neck might theoretically utilize the interface to write and communicate in addition to controlling their physical environment. The chips have only been partially tested on monkeys; it is yet unknown how they will affect human brains, which are much more complicated. Some experts have also questioned the company's moral character and suggested delaying the technology's wider testing until it can continuously show reliable and effective functioning over an extended period of time. It must, however, also overcome other obstacles, such as the requirement to create BCI technology that is more advanced and to handle security issues. The world may change through BCI technology if Neuralink can overcome these obstacles.

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