In the year Since its founding in 2016, Elon Musk’s neurotechnology company Neuralink has had the ambitious goal of implanting a next-generation brain with at least 100 times more brain connectivity than devices currently approved by the US Food and Drug Administration (FDA).
The company has now reached a big stage, it has been accepted FDA approval To start human trials. So what were the issues that kept the technology in the preclinical testing phase for as long as it did? And have these concerns been addressed?
What is Neuralink?
Neuralink is developing a class III medical device known as a brain-computer interface (BCI). The device connects the brain to an external computer via a Bluetooth signal, allowing for ongoing, continuous communication.
The device itself is a coin-sized unit called a link. It is implanted in a small disk-shaped incision on the skull using a precision surgical robot. The robot spliced a thousand tiny filaments from Link to specific neurons in the brain. Each strand is about a quarter the diameter of a human hair.
If Neuralink BCI can be safely implemented in humans, I believe the potential benefits will make the effort worthwhile.
The company says it’s a device that allows precise control of the prosthesis, allowing amputees to gain natural motor skills. It could revolutionize treatment for conditions such as Parkinson’s disease, epilepsy and spinal cord injuries. It also shows some promise for treating obesity, autism, depression, schizophrenia and tinnitus.
Several other neurotechnology companies and researchers have developed BCI technologies that have helped people with limited mobility regain mobility and complete daily tasks.
BCIs have also been used by older adults to train their motor and cognitive skills to reverse the devastating effects of aging.
Long road to FDA approval for human trials
In the year In February 2021, Musk revealed that Neuralink was working with the FDA. But the human trials did not begin in 2021.
Then, in March 2022, Neuralink submitted an additional application to the FDA to confirm its readiness to begin human trials.
One year and three months later, on May 25 2023, Neuralink finally received FDA approval for its first human clinical trial. With Neuralink pushing for licensing, we can only imagine that it will start soon.
The approval comes less than six months after the U.S. Office of Inspector General began an investigation into Neuralink over animal welfare violations.
What was the FDA’s concern?
The FDA had a list of issues to address before human trials could begin, according to a Reuters investigation, which spoke to multiple Neuralink sources.
Many of these concerns have required Neuralink to conduct extensive and repeated testing and data collection over a longer period of time. This may be the deciding factor as to why it took so long for the approval process to begin human trials.
It cannot be said with certainty that all issues have been fully resolved. But given the rigors of the FDA approval process, we can conclude that they have at least been resolved to some extent to the FDA’s satisfaction.
A precision robot known as Implant/r1 performs the surgical procedure to implant the Neuralink BCI. This robotic surgeon had to perform the procedure to safely and securely implant the Neuralink BCI without damaging the surrounding brain tissue, or risking infection, bleeding, swelling or scarring.
Harmful side effects
Once installed, the Neuralink BCI should work as intended. It should not inadvertently affect other brain functions or cause unwanted side effects such as seizures, headaches, mood changes or cognitive impairment.
Reliable power supply
In particular, overheating of lithium-ion batteries can pose a significant risk to BCI users. Such batteries have historically been known to overheat when defective. If the resistance between the cathode and the anode (parts of the metal electrodes) are damaged, they can even explode, resulting in a short circuit.
The longevity of the battery was also taken into consideration, as well as how easy it would be to replace it safely under the skin behind the ear. Since the FDA’s previous rejection, extensive testing has been conducted on the specially designed Neuralink battery to evaluate its performance, durability and bio-compatibility.
Then there is the risk of wire migration. A connector contains a disc-shaped chip with very thin wire electrodes that connect to neurons in the brain.
Connecting these wires with a surgical robot is a huge challenge in itself. But there is also the possibility that the electrodes may eventually move to another location in the brain due to natural movement, inflammation, or the formation of scar tissue. This may affect the proper functioning of the device, and may cause infection or damage to brain tissue.
Neuralink had to conduct extensive animal studies and provide evidence that the wires did not migrate significantly over time or have any negative effects on the brain. The company had to demonstrate that it has a method to monitor and adjust the position of the wires if necessary.
Another challenge Neuralink faced was safe implant removal. The FDA wanted to know how easy or difficult it would be to remove the device from the brain if necessary.
Data privacy and security
Strong safeguards are required to prevent data collected through the link from being intercepted, manipulated or otherwise used. Neuralink had to prove to the FDA that it would protect Link users from hacker hallucinations, as well as guarantee the privacy of the brainwave data generated by the device.
The way forward
Critics acknowledge Neuralink’s potential benefits, but warn the company is slow to accelerate. It will take time to adequately resolve these issues – and when you reach a resolution, the edges should not be cut.
Beyond Link’s potential medical uses, Musk has made several radical questions about his vision for the future of the technology. Neuralink says it can enhance human intelligence by interacting with artificial intelligence systems on demand — for example, with improved memory, and learning and problem-solving skills.
He even went so far as to say that the link could allow high-bandwidth telepathic communication between two or more people connected through an intermediary computer. Common sense dictates that these claims be placed in the “I believe it when I see it” category.
The situation with Neuralink has clear parallels with the advances in AI (and the growing need for control).
While these technologies are exciting, they should not be made public until their safety is proven. This can only be achieved through thorough testing.
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