Elon Musk, the renowned entrepreneur and visionary behind companies like Tesla, SpaceX, and Neuralink, is spearheading groundbreaking advancements in the field of neurotechnology. With his brain-chip start-up, Neuralink, Elon Musk aims to revolutionize the way we interact with technology by developing interfaces that directly connect the human brain with computers. Through Neuralink, Elon Musk envisions a future where individuals can seamlessly merge with artificial intelligence, unlocking new possibilities for medical treatments, communication, and human cognition. Elon Musk's unwavering commitment to pushing the boundaries of innovation has placed him at the forefront of the neurotech industry, with Neuralink poised to make remarkable strides in the coming years.
Elon Musk's brain chip startup, Neuralink, is set to commence human trials in the current year. The billionaire entrepreneur made this announcement during the VivaTech event in Paris on Friday. Musk stated that Neuralink plans to conduct its first trial by implanting the brain chip in a tetraplegic or paraplegic patient. While the exact number of patients and duration of the trials were not specified, Musk expressed optimism that the initial case would take place later this year. In addition to Neuralink, Musk serves as the CEO of Tesla, Twitter, and SpaceX. Neuralink recently achieved a significant milestone by obtaining clearance from the Food and Drug Administration (FDA) for its first-in-human clinical trial. This clearance is particularly crucial as the company faces investigations in the United States regarding its handling of animal experiments. The FDA has confirmed that Neuralink has been granted permission to utilize its brain implant and surgical robot for the trials, but further details have not been disclosed.
According to experts who spoke to Reuters, even if Neuralink can demonstrate the safety of its device in human trials, it could still take several years, potentially more than a decade, to obtain commercial use clearance. The company faces competition from other neurotech companies that have already successfully implanted their devices in individuals.
Elon Musk's previous projections about Neuralink's progress have not always been accurate. Since 2019, Musk has made at least four predictions about the imminent start of human trials, which have not materialized as expected.
Neuralink, established in 2016, initially applied for FDA permission in early 2022. However, the agency rejected the application, citing numerous safety concerns, as reported by Reuters.
The safety concerns raised by the FDA regarding Neuralink's device include issues related to the lithium battery, the potential migration of the implant's wires within the brain, and the difficulty of extracting the device without causing damage to brain tissue.
In addition to these concerns, Neuralink is currently under federal scrutiny following reports by Reuters regarding its animal experiments. Employees of the company disclosed that surgeries performed on monkeys, pigs, and sheep were rushed and mishandled, leading to a higher number of animal deaths than necessary. These actions were allegedly driven by pressure from Elon Musk to obtain FDA approval. The data obtained from these animal experiments was intended to support Neuralink's application for human trials, according to the sources cited.
During a particular incident in 2021, Neuralink mistakenly implanted incorrect-sized devices in 25 out of 60 pigs. As a result, all of the pigs had to be euthanized, an error that could have been easily prevented with better preparation, as stated by employees.
In May, lawmakers in the United States urged regulatory authorities to investigate whether the composition of Neuralink's panel responsible for overseeing animal testing played a role in the rushed and flawed experiments. This request was made following a Reuters report that highlighted potential financial conflicts within the board.
Furthermore, the Department of Transportation is conducting a separate investigation into whether Neuralink violated regulations by transporting hazardous pathogens on chips removed from monkey brains without appropriate containment measures. A spokesperson from the agency confirmed on Friday that the investigation is still ongoing.
Neuralink is currently under investigation by the US Department of Agriculture's Office of Inspector General for potential violations related to animal welfare. The focus of this probe is on the USDA's oversight of Neuralink. At the time of this response, there has been no immediate response from an agency spokesperson regarding the investigation.
Meanwhile, the valuation of Neuralink has significantly increased in recent months. The startup was valued at approximately $2 billion during a private fundraising round two years ago, but its value has now risen to around $5 billion based on privately executed stock trades, as reported by Reuters earlier this month.
It has been noted that employees of Neuralink who were part of the company's animal board, which has faced federal scrutiny due to potential conflicts of interest, could potentially benefit from the rapid development of the brain implant.