Neuralink, Elon Musk’s brain-machine interface device company has been given the green light from the US Food and Drug Administration (FDA) to begin a clinical study with humans as subjects. 

What Is Neuralink? 

Neuralink is a neurotechnology company co-founded by Elon Musk in 2016. The company aims to develop high-bandwidth brain-machine interfaces (BMIs) with the goal of merging the human brain with artificial intelligence (AI) and thereby advance human capabilities. 

The primary objective of Neuralink is to create a safe and effective means of connecting the human brain to computers or other external devices, e.g. enabling people who can’t use their hands to use their mobile-phone or other devices simply by thinking about it.  

Device Implanted 

This involves developing a device described as a “a general-purpose, high-bandwidth interface to the brain” with tiny, flexible electrode threads that can be implanted into the brain to establish a high-resolution interface with neural circuits. These threads are thinner than a human hair and can potentially record and stimulate electrical activity in the brain. 

Previous Test – Pigs 

Back in August 2020 there was news that neuralink was being tested in an experiment involving three pigs. One pig named Gertrude had the device implanted while another pig had previously been implanted with the device but had the device removed.  This pig was present to illustrate that the device could be removed safely and that this may be necessary as the hardware is updated over time and better versions become available.  The third pig had no implant fitted. 

The demonstration showed how the neural activity of Gertrude the pig could be sent wirelessly to a screen, and a series of bleeps sounded when the pig touched anything with her snout. This indicated that the device could read brain activity related to the search for food. 

Dystopian? 

At the time of the pig experiment, Neuralink received a Breakthrough Device designation from the U.S. Food and Drug Administration although some commentators have noted the potential dystopian possibilities of implants that could potentially be used for control, while People for the Ethical Treatment of Animals (PETA) reacted very angrily to Mr Musk’s use of pigs. PETA president Ingrid Newkirk issued a statement saying, “PETA challenges Elon Musk to behave like a pioneer and implant the Neuralink chip in his own brain.” 

In December 2022, Mr Musk was reported as saying that he’d be happy for a Neuralink to be implanted into the brain of one of his own children! 

Investigation 

Also in 2022, it was reported that Neuralink had killed about 1,500 animals in its experiments which prompted the USDA’s inspector general to begin investigation for possible violations of the Animal Welfare Act. 

Now Ready For Human Test – FDA Approval 

In the latest Neuralink progress announcement, Elon Musk has said that Neuralink  has been given the green light from the US Food and Drug Administration (FDA) (following a previous rejection last year) to begin an in-human clinical study, something that’s been promised four times since 2019. In a statement on Twitter, Neuralink announced: “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people. Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”

Issues To Address First 

The FDA’s approval was, however, accompanied by the need to address issues beforehand such as issues around the lithium battery of the device, whether the implant’s wires could migrate within the brain, and how the device could be removed safely without damaging the brain. 

What Are The Goals? 

The Neuralink project aims to achieve various goals, such as: 

– Medical Applications. Neuralink’s technology could potentially help individuals with neurological disorders, spinal cord injuries, or other conditions by providing a direct interface to their brain, bypassing damaged or nonfunctional parts of the nervous system. It could enable communication between the brain and external devices, offering new possibilities for treatment and rehabilitation. For example, the neuralink device could be used help deal with serious conditions such as Parkinson’s by helping sufferers to control their movement instead of relying on strong medication. It is also envisioned that it could help with conditions like obesity, autism, depression, and schizophrenia. 

– Brain-Computer Interface. Neuralink seeks to develop a means for individuals to control computers or other devices using their thoughts. This could have transformative implications for individuals with motor impairments or disabilities, allowing them to interact with technology more seamlessly, e.g. web browsing. More far-fetched suggested applications of Neuralink include enabling a kind of telepathy. 

– Augmented Human Capabilities. Neuralink envisions a future where humans can augment their cognitive abilities by directly integrating with AI systems. This could potentially enhance memory, learning, or problem-solving capabilities, leading to improved overall cognitive performance. 

– Advancing AI. Neuralink aims to facilitate a symbiotic relationship between humans and AI. By connecting the human brain to AI systems, it is hoped that humans can leverage AI’s computational power and analytical capabilities while providing the AI with direct access to the human brain’s vast capabilities, such as intuition, creativity, and emotional intelligence. 

Possibilities Highlighted By European Experiment 

The possible benefits of devices like Neuralink were highlighted recently when a digital bridge as a brain–spine interface device, developed by Neuroscientists at the Ecole Polytechnique Federale de Lausanne (EPFL) in Switzerland, allowed a previously paralysed man to stand, walk and even climb stairs. 

What Does This Mean For Your Business? 

The idea of Neuralink as a way to help with medical conditions is a positive and promising one offering hope to many people with the chance to achieve transformations that haven’t been possible before. Also, such devices could open up many other opportunities and whole new areas for development for companies and developers hoping to use the interface to link with a variety of products and services in a unique way.

The FDA approval is really just the next (albeit important) step in what is likely to be a long process in order to address the issues highlighted by the FDA but, although a dystopian idea to some, as demonstrated in a similar experiment in Switzerland, it has the potential to achieve incredibly positive results. There are also, however, many medical, legal, research and ethical challenges (the death of thousands of animals and potentially a human subject) to overcome before devices like this are used beyond research projects and further announcements will prove interesting.