Elon Musk’s Neuralink Granted FDA Approval for Human Brain Implant Research
Neuralink, the brain-implant company owned by billionaire Elon Musk, has achieved a significant milestone in its goal to push the limits of human potential.
On Thursday, the US Food and Drug Administration (FDA) approved Neuralink’s first human clinical tests. This marks a significant breakthrough after difficulties in securing FDA approval.
Tech mogul Elon Musk has a bold vision for Neuralink’s future technology. He believes that it could possibly cure conditions such as autism, obesity, schizophrenia, and depression.
Founded in 2016, this ultramodern neurotechnology company aims to develop brain-machine interface (BMI) implants. These devices will enable direct communication between computers and the human brain.
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…
— Neuralink (@neuralink) May 25, 2023
As it can potentially cure various medical conditions, it is designed to cure neurological disorders and even improve cognition. Despite earning public scrutiny and regulatory challenges, it is still at the top of biology, neuroscience, and technological advancements.
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In a technology-dependent world, these implants may even facilitate telepathy and web browsing. Musk’s trust in the safety of these devices is so high that he stated he was willing to have his own children implanted too.
Overcoming Regulatory Issues
However, gaining FDA approval has not been an easy journey. In 2019, Elon Musk expected on four different events that Neuaralink could start human trials.
In 2022, Neuralink first applied for FDA approval but was rejected. According to Reuters, seven former and current employees confirmed this in March 2023.
Congratulations Neuralink team! https://t.co/AWZGf33UDr
— Elon Musk (@elonmusk) May 26, 2023
The FDA noted several concerns about Neuralink that they must acknowledge before giving the green light to human trials. Some of these concerns are the implant wires’ risks of moving inside the brain, the device’s lithium battery, and the safety of the device removal without harming the brain tissue.
Neuralink also faced public criticism, and the neurotechnology company has been under federal probes.
In May 2023, US lawmakers asked the regulators to investigate the panel supervising animal trials at Neuralink. This is after accusations of botched and rushed experiments surfaced.
The US Department of Agriculture’s Office of the Inspector General is also investigating possible animal-welfare negligence.
In addition, the Department of Technology is probing if Neuralink has illegally transported hazardous pathogens on chips they have removed from monkey brains without appropriate containment securities.
Neuralink’s Next Steps
Despite the hurdles, the company kept its top momentum. FDA’s approval is the first critical step that could open the doors to the widespread trials of this advanced technology.
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Neuralink tweeted, “This represents an important first step that will one day allow our technology to help many people.”
Still, as Neuralink moves to its next steps, the details of the study are still unknown. The company will soon begin recruitment for the trial and announce to release details soon.
If successful, these devices can transform the norm of treating various diseases. Amid the challenges, one thing is for sure; Neuralink’s story is just getting started.
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