Neuralink, a company with a mission to create an exceptional brain-computer interface, has hit a significant hurdle. The FDA denied Neuralink’s request for human testing, citing safety concerns as the reason behind the rejection.
The grand aspirations of Neuralink have encountered hindrances
Neuralink’s goal of developing a brain-computer interface that surpasses anything currently available has encountered a major setback. Last year, the FDA denied the company’s application for human testing, citing worries about potential safety issues.
Concerns cited by the FDA
The FDA raised multiple safety concerns regarding the proposed brain-computer interface. One of the issues highlighted was the potential migration of the implanted “neural lace” through the brain’s soft tissue. Another concern was the overheating of the device. The FDA also expressed worry about the implanted battery failing. Additionally, they highlighted the possibility of brain damage during removal as another concern.
Normal concerns for medical devices
The FDA rejected Neuralink’s bid to conduct human testing of its brain-computer interface due to safety concerns, a typical response for medical devices that companies usually address before reapplying. The report didn’t show any signs of extreme frustration or disappointment among anyone involved. However, some sources claimed that Elon Musk is experiencing frustration due to the slow pace of progress.
The FDA’s justified caution
The FDA’s caution is justified, given that Neuralink proposes an entirely new in-body electronic system and a new robotic method of implantation. Furthermore, the company has been cited for cruelty in its animal testing, possibly in pursuit of faster progress.
Guardrails on ethical animal testing
While animal testing can be unavoidably cruel, there are guardrails on what is ethical for testers to inflict on animals, and Neuralink has reportedly exceeded those. One co-founder is leaving to form a new brain implant company, Precision Neuroscience, which just raised $41 million.
Doubts about Neuralink’s progress
Neuralink is very secretive, like Musk’s other companies, and only shares progress in the form of occasional, carefully curated events. While a working implant in a seemingly happy monkey is promising, it’s hardly proof that the tech is ready for human testing.
Pursuing lofty applications
A company that wants to pursue lofty applications such as restoring sight and mobility must first prove that the implants are safe at a basic level. Most companies working in this space have been doing so for years, up to and including their FDA approval for human testing and use, without making the kind of promises Musk has on behalf of Neuralink.
Conclusion
The FDA’s rejection of Neuralink’s application for human testing of its brain-computer interface highlights the potential risks and challenges of pursuing breakthrough technologies that have the potential to revolutionize medicine. As discussed in a previous post, brain chips have the potential to bring many exciting possibilities, but they also raise concerns about privacy, ethics, and safety. With the FDA’s caution, it is important for companies like Neuralink to carefully address these concerns before proceeding with human testing. Nonetheless, the pursuit of brain-computer interfaces remains an exciting area of research with immense potential for the future of medicine.