Neuralink Human Testing Fails to Receive FDA Approval on First Try

Recent setbacks for Neuralink have investors questioning whether the company has the capacity to realize its ambitious goal of providing a brain-computer interface that is orders of magnitude better than what is currently available. While fans of Neuralink remain confident that the technology can be developed, some are beginning to wonder if the company’s management team has enough experience in this area.

The company’s 2022 bid for human testing was rejected by numerous concerns cited in the report, which indicates that they may not be ready to begin full-scale human trials yet. It is unknown if the company will resubmit their bid, but until they do it remains unclear just how close they are to beginning human trials for this controversial technology.

One of the concerns that has been brought up about the Block Tai device is that it may be unsafe. That being said, this same concern could be raised with any other medical device, and generally one gets back to work and tries again a year later.

It seems that SpaceX is having some difficulty ramping up production at their plant, while Neuralink has been making progress but is still struggling to bring their technology to market. It may be that Neuralink’s lack of experience in the manufacturing process is causing them some trouble, while SpaceX’s larger size and expertise should make the production process much easier.

Neuralink’s animal testing is raising some eyebrows, but the FDA has a valid reason for being wary. Neuralink is proposing an entirely new method of implantation and even a brand-new in-body electronic system, which could be incredibly disruptive. Additionally, Neuralink has been cited for cruelty in its animal testing before, which is admittedly in a way unavoidably cruel. However, there are guardrails on what is ethical for testers to inflict on animals and Neuralink has reportedly exceeded those. This means that neural implants may eventually become possible but only if the company can prove that their practices are humane.

Despite the many challenges that have befallen the company, it is clear that the employees are still dedicated to its success. The co-founders and leaders who have left recently may have found a new challenge and opportunity in Precision Neuroscience, but their departure has demonstrated just how committed these employees are to helping the company achieve its goals. It will be interesting to see how this latest setback affects their commitment and productivity going forward.

In the years since Neuralink’s founder, Elon Musk, first mentioned his plans to create a brain-computer interface (BCI) technology, there has been much hype and speculation surrounding the company. While it is still unclear when or if Neuralink will be able to deliver on its promise of an implant that can directly communicate with a human brain, recent events have provided some hope for those desperate for this technology to be available. In January 2019, video footage surfaced of what appeared to be a monkey wearing an implant that was capable of communicating with its handlers via computer. The monkey seemed happy and content as it reacted delightedly to various objects being presented to it. This small success provides some encouragement for those who are doubtful about whether or not Neuralink will ever be able to realize their full potential in developing BCIs for humans. However, given the often secretive ways in which Neuralink shares information about their progress, it is difficult determine just how far they have come and how much work remains ahead of them.

Even if Neuralink is able to perfect its implant technology and secure FDA approval, the journey from research to widespread implementation will be a long and difficult one. There are still many unanswered questions about the risks and benefits of neural implants, which means that any company pursuing this type of ambitious project will have to make sure they are fully aware of all potential consequences before they even begin.

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Kira Kim

Kira Kim is a science journalist with a background in biology and a passion for environmental issues. She is known for her clear and concise writing, as well as her ability to bring complex scientific concepts to life for a general audience.

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