Elon Musk's Neuralink brain chip approved for human testing

Since its founding in 2016, billionaire Elon Musk's neurotechnology company Neuralink has been on an ambitious mission to build a next-generation brain implant with at least 100 times more brain connections than current FDA-approved devices.

Illustration photo.

The company has now reached a major milestone in its research and testing process by receiving FDA approval to begin human clinical trials.

What is NeuraLink?

Neuralink is an American neurotechnology company founded by billionaire Elon Musk, with the mission of developing implantable brain-computer interfaces, headquartered in San Francisco, California (USA). The company is currently researching and developing a class III medical device called a brain-computer interface (BCI).

Class III medical devices are devices that pose a high risk to the patient and/or user. These devices typically maintain or support life and are implanted in the human body. They represent 10% of medical devices regulated by the FDA. Examples of Class III devices include implantable pacemakers and breast implants.

The device connects the brain to an external computer via Bluetooth, allowing constant back-and-forth communication. The device itself is a coin-sized block called the Link. It is implanted into a small disc-shaped incision in the skull by a precision surgical robot. The robot then connects thousands of tiny connecting wires from the Link to specific neurons in the brain. Each wire is about a quarter the diameter of a human hair.

Potential benefits

According to Neuralink, the device could enable precise control of prosthetic limbs, giving amputees natural motor skills. It could revolutionize the treatment of conditions like Parkinson’s disease, epilepsy, and spinal cord injuries, helping paralyzed people walk, blind people see, and eventually turning people into cyborgs. It also shows some promise in treating obesity, autism, depression, schizophrenia, and tinnitus.

Several other neurotechnology companies and researchers have developed BCI technologies that help people with limited mobility regain movement and complete everyday tasks.

BCIs have also been used to help older adults train their motor and cognitive skills to lessen the worst effects of aging.

The Long Road to FDA Approval for Human Trials

In February 2021, Elon Musk said Neuralink was working with the FDA to get approval to begin initial human trials by the end of that year. But human trials did not begin in 2021.

Then, in March 2022, Neuralink filed a follow-up application with the FDA to establish its readiness to begin human trials.

More than a year after submitting its application, on May 25, 2023, Neuralink finally received FDA approval for its first human clinical trial.

The approval comes less than six months after the US Office of Inspector General opened an investigation into Neuralink for potential animal welfare violations.

What are the FDA's concerns?

Before starting human trials, the FDA raised a number of concerns that it asked Neuralink to address. Most of these concerns called for Neuralink to conduct thorough and repeated testing and collect data over a long period of time. This may have been a deciding factor in why the approval process to begin human trials took so long.

It is impossible to say with certainty that all the issues have been completely resolved. But given the rigor of the FDA approval process, we can conclude that they have at least been resolved to the FDA's satisfaction.

Safe surgery

A precision robot called Implant/R1 performs the surgical procedure to implant the BCI device. The surgical robot has gone to great lengths to demonstrate that it can reliably and safely implant and remove the BCI device without damaging surrounding brain tissue or creating the risk of infection, bleeding, inflammation, or scarring.

Adverse side effects

Once implanted, the BCI device must function as intended. It must not inadvertently interfere with other brain functions or cause any unwanted side effects such as seizures, headaches, mood swings, or cognitive impairment.

Safe power source

Another particular concern is that the lithium-ion batteries used in BCI devices can pose a significant risk to BCI users if they overheat. They can even explode if the insulation between the cathode and anode (the metal electrode components) is damaged, resulting in a short circuit.

The battery's longevity was also taken into account, as was how easily it could be safely replaced from its location under the skin behind the ear. Since the previous FDA rejection, extensive testing has been conducted on the battery used in the BCI device, to assess its performance, durability, and biocompatibility.

Move the connecting wires

The next concern is the movement of the very thin wires used to connect a disc-shaped chip to electrodes that connect to nerve cells in the brain.

Connecting these wires using a surgical robot is a major challenge in itself. But there is also the possibility that the electrodes could migrate to other places in the brain over time due to natural movement, inflammation, or scar tissue formation. This could interfere with the device’s normal functioning and potentially cause infection or damage to brain tissue.

Neuralink would have to conduct extensive animal studies and provide evidence that the wires would not move significantly over time or cause any adverse effects on the brain. The company would also have to demonstrate that it has a way to monitor and adjust the wires' position if this becomes necessary.

Removal of implanted device

Another challenge Neuralink faces is safely removing the implant. The FDA wants to know how easy or difficult it would be to remove the implant from the brain if that becomes necessary.

Privacy and data security

Robust safeguards are needed to prevent the data collected by the Link implant from being hacked, manipulated, or misused. Neuralink must assure the FDA that it can avoid hacker scenarios that could compromise Link users, as well as ensure the privacy of the brainwave data generated by the device.

The Road Ahead for Neuralink

Critics acknowledge Neuralink’s potential benefits, but warn that the company should ramp up slowly. Satisfactorily addressing these issues will take time, and there should be no shortcuts in the testing process.

In addition to Link's potential medical applications, billionaire Elon Musk has made several radical statements regarding his future vision for the technology.

He has claimed Neuralink could enhance human intelligence by creating on-demand connections with artificial intelligence systems, such as allowing for improved cognition through enhanced memory as well as improved learning and problem-solving skills.

The boss of the Neuralink project even said that Link could allow high-bandwidth telepathic communication between two or more people connected through an intermediary computer./.

Phan Van Hoa