Having wiring in our brains seems like an inevitable thing as we progress with technology, but we might be waiting just a bit longer. The FDA reportedly denied the request of Neuralink to start human trials, seeing as there are still a few kinks that need to be sorted out.
Request Denied
The US Food and Drug Administration appears to have a different plan in mind when it comes to Neuralink, even though Elon Musk claimed that the company would get approval within six months back in November 2022.
The FDA denied authorization back in 2022 due to the brain-computer interface (BCI) device trial resulting in the death of animal test subjects, particularly pigs. There are concerns about the battery system and "novel transdermal charging capabilities" failing.
As mentioned in Engadget, the agency's major safety concerns are with the device's lithium battery specifically the implant's wires potentially migrating to other areas of the brain. There's also the possibility of causing tissue damage when the device is removed.
The FDA will need the battery of the BCI device to have a very high chance of success before the company could get approval for human trials. Otherwise, the tissue surrounding the implant might be fried should the device's pack rupture due to electrical currents or heat energy.
Given that upgrades or replacements will soon come after implantation, the agency is also wary of problems that may arise due to the small size of the electrical leads. Due to its size, there's a possibility of it breaking off when removed and could travel to places that will harm the brain.
Neuralnk's Goals and How It Works
Neuralink aims to create a direct link between the human brain and the technology that is used every day. The implants could help people with paralysis control computers and mobile devices, therefore regaining their independence despite the loss of muscle function.
The brain-computer interface company also believes that the development of technology could potentially treat a number of neurological disorders, which could restore sensory and motor function.
Since our brains communicate through electric signals, Neuralink will implant electrodes near the neurons to detect action potential. Action potentials cause synapses to release neurotransmitters and the implant may record it and decode what the brain intends to do.
As mentioned on Neuralink's website, the electrodes need to be placed inside the brain for a more precise reading. Although neural activity can be recorded through non-invasive techniques like EEG, it records the "summed activity of millions of neurons."
Neuralink likened EEG with experiencing a sporting event through a microphone placed outside the stadium. Even if the EEG reading provides useful information, a connection direct to the source can record neural spikes from individual neurons.
Neuralink's objective is to design a fully implantable and cosmetically invisible brain-computer interface. Micron-scale threads will be inserted into the areas where brain activity represents movement. Each thread will have several electrodes that will connect them the implant.
