Neuralink, the brain chip company founded by Elon Musk, has announced that it has received approval from the US Food and Drug Administration (FDA) for its initial human clinical trial.
In a tweet, Neuralink stated that the FDA’s approval is a crucial first step towards leveraging their technology to assist numerous individuals in the future.
This approval marks a significant milestone for Neuralink, considering the challenges it faced in obtaining regulatory clearance. The company assured that additional details would be forthcoming shortly.
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What Neuralink is
Demonstrations by the startup revealed that Neuralink prototypes, resembling the size of a coin, are implanted in the skull.
These demonstrations showcased the utilization of a surgical robot to replace a section of the skull with a Neuralink disk.
Delicate wires from the disk are then carefully inserted into specific areas of the brain. Through this process, the disk is able to detect and record nerve activity, transmitting this information wirelessly via Bluetooth to devices like smartphones, as explained by Musk.
So far, the startup has revealed that Neuralink has been successfully implanted in the skulls of monkeys.
Elon Musk, during a previous presentation, mentioned that the implant fits comfortably within the skull and could be concealed beneath the hair without detection.
In a previous showcase, Neuralink demonstrated how monkeys were able to “play” basic video games or manipulate a cursor on a screen through their Neuralink implants. The technology has also undergone testing on pigs.
Connection with human minds
Neuralink has not yet opened recruitment for a clinical trial involving humans, as stated by the company.
Elon Musk, who recently founded a business focused on advanced artificial intelligence, argues that establishing a connection between human minds and machines is crucial to prevent falling behind artificial intelligence.
However, experts and academics maintain a cautious approach towards his vision of merging human minds with highly advanced computing in a symbiotic manner.
What is Neuralink’s aim?
The firm says Neuralink is actively working towards developing a novel method to enable direct communication between computers and the human brain.
The underlying aspiration is to address intricate neurological disorders that have thus far been beyond the reach of existing medical interventions.
These encompass a wide spectrum of conditions, including paralysis, blindness, depression, and schizophrenia. By establishing this direct interface, Neuralink aims to unlock potential solutions for these complex neurological challenges.
The procedure
The procedure would involve implanting a tiny hermetically sealed chip directly into a patient’s brain.
The chip is connected to 1,024 tiny electrodes, no thicker than a human hair and is powered by a battery that can be recharged wirelessly.
It would create an interface with an external computer, allowing it to both send and receive signals.
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How safe is the Trial on Humans
Short-term physical risks, long-term medical concerns, and ethical safety are three main aspects to consider in this context, according to experts.
Engaging in any brain surgery inherently carries risks, both in terms of physical harm and potential rejection by the recipient’s body.
Extensive testing on animals, while controversial, has been conducted to assess the efficacy of the Neuralink chips.
A complaint lodged with the US Department of Agriculture in February alleged the mistreatment of macaque monkeys utilized in testing this technology, highlighting concerns regarding animal welfare.
Nevertheless, the approval from the FDA for human testing suggests that Neuralink has successfully addressed some of these challenges.
However, more significant concerns arise regarding the long-term implications of having such a device operating within the intricacies of the human brain, an organ that we are only just beginning to comprehend.
Currently, there is no available data on potential harm, but this will change as testing progresses on human subjects, playing a pivotal role in the advancement of similar products.
The final aspect, ethical safety, is a subjective matter. Technologies like this are accompanied by concerns regarding data protection, potential applications, and the possibility of human enhancement.
This entails enhancing or augmenting the capabilities of the human brain beyond its current capacity, such as improving cognition, sensory perception, or physical abilities. These possibilities often evoke strong emotions and raise ethical questions, leading to calls for stringent regulation within the field.