Musk’s Neuralink Has Now Obtained Approval for Human Trials. Here’s Why It Took So Long.
Ever since its establishment in 2016, Neuralink, the neurotechnology venture of Elon Musk, has embraced a grand mission to construct a next-generation brain implant featuring no fewer than 100 times the number of cerebral connections found in devices presently sanctioned by the US Food and Drug Administration (FDA).
Recently, the company reached a momentous milestone by securing FDA authorization to initiate human trials. What were the impediments that protracted the technology’s pre-clinical trial phase for such a substantial duration? And have these concerns been adequately addressed?
What is Neuralink?
Neuralink is devoted to fabricating a Class III medical apparatus identified as a brain-computer interface (BCI). This groundbreaking device facilitates an incessant bidirectional exchange of information by wirelessly linking the brain to an external computer through Bluetooth technology.
The device itself assumes the form of a coin-sized unit known as a Link. It is surgically implanted within a small circular incision in the skull with utmost precision, courtesy of a surgical robot. This remarkable machine meticulously attaches thousands of diminutive filaments originating from the Link to specific neurons in the brain. Remarkably, each of these filaments measures a mere fraction of the diameter of a human hair.
Prospective Advantages
If Neuralink’s BCI can be developed to ensure the safety of human subjects, the prospective benefits that may ensue would render the arduous efforts worthwhile.
The company maintains that this device could enable intricate control over prosthetic limbs, granting amputees an innate range of motor abilities. It holds the potential to revolutionize the treatment of various conditions, including Parkinson’s disease, epilepsy, and spinal cord injuries. Furthermore, it exhibits promise in the potential treatment of obesity, autism, depression, schizophrenia, and tinnitus.
Several other organizations and researchers specializing in neurotechnology have already devised BCIs that have significantly aided individuals with limited mobility, helping them regain motor function and accomplish daily tasks.
BCIs have also been employed to facilitate the training of older individuals, enhancing their motor and cognitive capacities and mitigating the most debilitating effects of the aging process.
The Prolonged Path to FDA Approval for Human Trials
In February 2021, Musk declared that Neuralink was collaborating with the FDA to obtain the necessary authorization to initiate preliminary human trials later that same year. However, these trials did not commence in 2021 as initially anticipated.
Subsequently, in March 2022, Neuralink submitted a supplementary application to the FDA, seeking validation of their readiness to embark on human trials.
One year and three months later, on May 25, 2023, Neuralink finally obtained FDA approval for its inaugural human clinical trial. Given the unwavering determination exhibited by Neuralink in their pursuit of authorization, it is reasonable to surmise that the trial will commence imminently.
This approval arrived less than six months after the US Office of the Inspector General initiated an investigation into Neuralink’s potential violations of animal welfare.
What Concerns Did the FDA Raise?
According to an investigation conducted by Reuters, which purportedly involved conversations with multiple sources from Neuralink, the FDA highlighted a considerable number of concerns that necessitated resolution prior to the commencement of human trials.
Most of these concerns demanded that Neuralink conduct exhaustive and repeated testing, coupled with comprehensive data collection over an extended period. This rigorous approach likely played a decisive role in prolonging the approval process for human testing.
While it cannot be definitively stated that all the issues have been fully rectified, it is reasonable to conclude, given the exacting standards of the FDA’s approval process, that they have been addressed to a satisfactory degree.
Surgical Safety
To ensure the safety of the surgical procedure for implanting the Neuralink BCI, a precision robot called Implant/r1 has been developed. This robotic surgeon underwent thorough examination to ascertain its reliability and capacity to implant and remove the Neuralink BCI without compromising the surrounding brain tissue, or incurring the risk of infection, bleeding, inflammation, or scarring.
Mitigation of Adverse Effects
Once implanted, the Neuralink BCI must perform as intended without unintentionally influencing other brain functions or causing undesired side effects such as seizures, headaches, mood alterations, or cognitive impairment.
Reliable Power Supply
Particular attention has been given to averting potential hazards posed by overheating lithium-ion batteries in BCIs. Historical instances of these batteries overheating, and in extreme cases, exploding due to breakdowns in insulation between the cathode and anode (the metal electrode components) resulting in short circuits, have underscored the significance of this safety concern.
Additionally, the battery’s lifespan was assessed, along with the ease of safe replacement located beneath the skin behind the ear. Extensive testing has been conducted on the specially designed Neuralink battery since the FDA’s previous rejection, evaluating its performance, durability, and compatibility with the human body.
Prevention of Wire Migration
Another formidable challenge involves the risk of wire migration. The Link incorporates a disk-shaped chip accompanied by extremely thin wire electrodes that establish connections with neurons in the brain.
The connection of these wires by means of a surgical robot presents a considerable challenge in itself. Furthermore, there exists the possibility that over time, due to natural movement, inflammation, or the formation of scar tissue, the electrodes may migrate within the brain. Such migration would likely impede the device’s proper functionality and could result in infection or damage to brain tissue.
Neuralink was compelled to conduct extensive animal studies and provide evidence that their wires did not migrate significantly over time, nor induce any detrimental effects on the brain. Additionally, the company had to demonstrate a methodology for monitoring and adjusting the position of the wires, if necessary.
Implant Removal
Neuralink also faced the challenge of ensuring the safe removal of the implanted device from the brain. The FDA required an assessment of the ease or difficulty involved in this procedure.
Data Privacy and Security
Stringent measures are imperative to safeguard the data collected by the Link from potential hacking, manipulation, or misuse. Neuralink had to assure the FDA that they could forestall nightmarish scenarios in which hackers compromise the security of Link users, while simultaneously ensuring the privacy of the brainwave data generated by the device.
The Path Ahead
Critics acknowledge the potential benefits offered by Neuralink but advise the company to proceed cautiously. Addressing these issues comprehensively will undoubtedly require a considerable amount of time, and it is crucial that corners are not cut in the pursuit of solutions.
Beyond the medical applications of the Link, Musk has made audacious claims concerning his vision for the future of this technology. He suggests that Neuralink has the potential to enhance human intelligence by enabling an on-demand connection with artificial intelligence systems. This could result in improved cognition through enhanced memory, learning, and problem-solving capabilities.
Musk has even ventured to propose that the Link could facilitate high-bandwidth telepathic communication between multiple individuals connected via an intermediary computer. It would be prudent to regard these claims with skepticism until concrete evidence is presented.
The situation with Neuralink bears clear parallels to current advancements in AI and the growing imperative to regulate it. As exhilarating as these technologies are, they must not be released to the public until their safety is proven beyond a doubt, a feat that can only be accomplished through exhaustive testing.
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