Elon Musk's 'Human-AI Symbiosis' Dream Advances: Neuralink Receives Human Trial Approval—How Far Is Commercialization?

NBD Reporters: Li Menglin, Wen Qiao | NBD Editor: Lan Suying

Three years ago, Elon Musk’s brain-computer interface company, Neuralink, sparked a wave of “BCI fever” by livestreaming real-time neuronal activity from three pigs implanted with brain devices to the world. At the time, Musk optimistically stated that human trials for brain-computer interfaces would begin soon. However, the path to regulatory approval has proven far more complex than Musk had anticipated.

This week, Neuralink finally obtained approval for human clinical trials, advancing Elon Musk’s sci-fi dream of “human-machine symbiosis” by one step.

Cristin Welle, a former U.S. Food and Drug Administration (FDA) official responsible for pharmaceutical regulation and a neuroscience researcher, told a reporter from the National Business Daily that this approval indicates Neuralink has provided data meeting the FDA’s safety requirements.

“Will the brain-computer interface device be immediately available on the market after this trial? Weir explained, ‘Larger-scale trials are still needed, followed by pivotal trials, before applying for premarket approval (PMA).’”

Musk’s “Human-Machine Symbiosis” Dream Takes a Significant Step Forward

On September 19 (local time), Neuralink announced on its official website that it would recruit participants for the first-in-human clinical trial of its brain-computer interface device, aiming to evaluate the safety and preliminary efficacy of the device, specifically whether paralyzed patients can control external devices using their thoughts.

It is reported that this project, named PRIME (PrecisionRobotThe trial of the implantable brain-computer interface (BCI) will use the surgical robot R1 to place the implant N1 into the brain region that controls motor intent. N1 is an ultra-thin, flexible wire capable of recording neural signals and wirelessly transmitting them to an application that decodes motor intentions.

Neuralink stated that the company is seeking trial participants with quadriplegia resulting from spinal cord injury or amyotrophic lateral sclerosis (ALS, commonly known as Lou Gehrig’s disease), who have shown no improvement for at least one year post-injury. The primary trial will last approximately 18 months, and the entire clinical trial, including long-term follow-up consultations, will take approximately six years.

It has been four years since Neuralink first submitted its clinical trial application, during which time the FDA rejected it twice. In early 2022, the FDA explicitly stated that Neuralink needed to address dozens of issues before proceeding with human trials, citing safety concerns such as the safety of lithium batteries, the potential for implant wires to migrate to other areas, and issues related to safe removal. In May 2023, the FDA finally granted Neuralink conditional approval for its trial.

“The FDA does not disclose review information on investigational new drug applications,” said Christine Well, former FDA official and current associate professor of neuroscience at the University of Colorado in the United States, in an interview with the National Business Daily, “butSince the FDA has approved the initiation of the trial, it indicates that Neuralink has provided data meeting the FDA’s safety requirements and has proposed an appropriate clinical trial design.”

The preliminary objective of this trial is to enable paralyzed individuals to control a computer cursor or keyboard using only their thoughts. According to Elon Musk’s statements at various occasions in recent years, Neuralink’s short-term goals are to restore vision in the blind and help paralyzed individuals regain full-body motor function, whileThe ultimate goal is to achieve “human-computer symbiosis,” where the human brain and computers work collaboratively.to resist the artificial intelligence that he perceives as a potential threat to humanity.

Just like Musk’s dream of immigrating to Mars, brain-computer interfaces also have their roots in science fiction. According to the newly published biography Elon Musk in September, the concept behind Neuralink was inspired by Iain Banks’ space travel novel series Culture, which mentions a device called “neural lace” that, when implanted into the human body, can connect all of a person’s mental activities to a computer. Musk said, “When I first read Banks’ work, I suddenly felt that this idea could become our shield against artificial intelligence.”

It may take 5 to 10 years to achieve commercialization

After Stumbles, Neuralink Lags Behind Rivals in Human Trial Progress

Another U.S. brain-computer interface company, Synchron, received FDA approval for clinical trials in 2021 and announced the first implantation of a brain-computer interface in the United States in July 2022, publishing preliminary trial results. In May 2023, a team of Swiss researchers published an article in Nature, stating that they had implanted a brain device in a paralyzed man as early as July 2021, enabling him to regain the ability to walk with the assistance of a walker.

Of course, Neuralink does possess its own technological advantages. Traditional implantable brain-computer interfaces (BCIs) employ rigid electrodes known as “Utah arrays,” whereas Neuralink utilizes flexible electrodes, which can reduce the brain’s immune rejection response and yield higher-quality neural signal acquisition. Furthermore, Neuralink has developed a surgical robot for BCI implantation, designed to minimize tissue trauma during both the insertion and removal of the device.

To realize Musk’s grand vision, this human trial is but a small step forward. “Neuralink is still in the very early stages of device development and commercialization, currently undergoing early-phase human trials. Larger-scale trials are still needed, followed by pivotal trials, before applying for pre-market approval.（PMA）。"Christine Weil told a reporter from the National Business Daily."

Kristin Well further explained to reporters that, following this small-scale human trial, Neuralink will apply for a larger-scale feasibility study based on the trial data. Since brain-implantable devices are highly likely to be classified as Class III (highest risk) medical devices, Neuralink must also obtain premarket approval before commercialization. This means that Neuralink will need to conduct large-scale pivotal trials to demonstrate that its device can effectively treat a specific condition and is safe and reliable.

This process requires a significant amount of money and time, Christine Ver previously stated to the media,Neuralink will need at least another 5–10 years before commercialization becomes possible.

On the other hand, Neuralink also faces multiple challenges in terms of technology and application prospects. Kristin Vell analyzed this for reporters from NBD, pointing out thatNeuralink needs to demonstrate that its device can remain implanted in the brain long-term without requiring frequent replacement, that it can capture and interpret neuronal signals, and most importantly, that this technology provides tangible benefits to patients.

“Even if Neuralink can meet all these conditions, the device will certainly be expensive and require brain surgery, so the number of patients willing to accept the implant may be relatively small,” said Christine Vell.

Responsible Editor: Li Yuan