Elon Musk’s Neuralink’s FDA approval: 5 big things to know

 Elon Musk’s Neuralink’s FDA approval: 5 big things to know

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Neuralink, the brain-implant company founded by Elon Musk, has received approval from the US Food and Drug Administration (FDA) to conduct its first-in-human clinical study. Neuralink’s FDA approval signifies a significant milestone for the company and the field of neurotechnology.

By obtaining FDA approval for its clinical study, Neuralink can now begin gathering valuable data on the safety and efficacy of its brain-implant technology in human subjects.

Here are 5 key things to know, to understand more the company and impact of the latest development.

1. What is Neuralink and what does it aim to do?

Elon Musk established Neuralink as a company in 2016 with a team of seven scientists and engineers. Elon Musk, the well-known entrepreneur and CEO of companies like Tesla and SpaceX, founded the company in relative stealth. It first became publicly known in March 2017 and has garnered significant attention and publicity since then.

Neuralink aims to develop advanced brain-computer interface (BCI) technology that could potentially enhance human capabilities, treat neurological disorders, and enable a direct interface between the brain and external devices. The company’s goal is to enable a direct connection between the human brain and computers or external devices, potentially revolutionizing the way humans interact with technology.

Neuralink’s main objective is to help people with communication limitations regain the ability to interact with others and control digital devices using their thoughts.

2. How does Neuralink’s proposed solution work?

Neuralink’s approach involves inserting micron-scale threads into specific areas of the brain that control movement. These threads are thinner than a human hair and can listen in on neurons. They are strategically placed close to important parts of the brain to detect and record neural impulses.

These threads are connected to a small chip called the N1, which is implanted into the skull. The threads extend from the chip and reach out into the brain to establish the connection. The threads are capable of detecting neural messages as they are relayed between neurons, recording each impulse. Additionally, they can stimulate neural activity themselves. The goal is to allow the brain to interface directly with computers or mobile devices, enabling individuals to control technology through their thoughts.

Neuralink aims to design flexible threads to minimize potential damage to surrounding brain tissue. This is an important consideration to ensure the long-term viability and safety of the brain implant technology.

Also read: ChatGPT creator OpenAI & its surge now under investigation by Canada

3. Does Neuralink’s FDA approval mean it has already conducted animal trials?

Neuralink has indeed conducted animal trials as part of its research and development process. The company has conducted tests with prototypes in animals such as pigs and monkeys, demonstrating advancements in brain implant technology. Since 2018, Neuralink has tested on and, according to company estimates, killed around 1,500 animals, including sheep, pigs, monkeys, rats, and mice. The animals used in the trials reportedly include over 280 sheep, pigs, and monkeys.

In fact, Neuralink has also faced federal investigation for potential animal welfare violations related to its animal trial program. Internal staff complaints prompted the investigation. Law enforcement officials are scrutinizing both Neuralink’s animal trial program and the US Department of Agriculture’s oversight of the company’s operations.

In April 2021, Neuralink showcased a monkey, named Pager, playing the game “Pong” using the Neuralink implant. Pager initially learned to play Pong using a joystick. During the training, the Neuralink implant recorded the brain’s electrical activity to map the relationship between neural signals and specific movements required to play the game. After the initial training phase, the joystick was disconnected, and Pager continued playing Pong solely by using its thoughts and neural signals.

4. What does Neuralink’s FDA approval for human trials mean?

This FDA approval grants Neuralink the authorization to move forward with its plans to implant chips in the human brain and conduct a clinical study on human participants. The approval comes after extensive collaboration between Neuralink and the FDA, highlighting the company’s commitment to meeting regulatory requirements. This achievement can be considered a critical milestone for Neuralink, as it paves the way for further research and development of brain-computer interfaces.

One of the intended applications of Neuralink’s technology is to enable individuals with conditions such as paraplegia, who may have limited or no physical movement, to manipulate computers or mobile devices using speech or text synthesis. This would allow them to perform tasks like browsing the web, creating digital art, and using virtual mouse and keyboard controls

The company’s plan is to implant up to four chips connecting with thousands of neurons in these patients. With the human trials approval, Neuralink could try and test this out on volunteer human subjects.

5. Which investors have funded the company?

Neuralink raised US$205 million in a Series C funding round in July 2021. Dubai-based venture capital firm Vy Capital led the round. Other notable investors such as Google Ventures, DFJ Growth, Valor Equity Partners, Craft Ventures, Founders Fund, and Gigafund, participated.

It is worth noting that funding databases list Sam Altman, the CEO of OpenAI, the creator of ChatGPT, as an investor in Neuralink.

As per Tracxn’s data, the company also secured funding of US$39.3M in Series C earlier in May 2019 and US$27M Series B in August 2017. However, the participants of the earlier rounds are not publicly known. Overall, Neuralink has raised a total funding of US$271M over 3 rounds.

In conclusion

Neuralink’s advancements in brain-computer interface technology have the potential to significantly impact the world in various ways. The FDA approval for human trials gives it a significant boost in achieving its goals. At the same time, like any emerging technology, Neuralink’s human trials carry certain risks that need to be considered, including ethical and malicious intent concerns.

How this plays out for humankind, only time will tell.


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