After receiving official approval from the US Food and Drugs Administration (FDA), Neuralink, the brain chip company founded by Elon Musk, is preparing to conduct its first clinical study in humans.
The tests involve the implantation of a device in the brain of human volunteers, with the promise of, in the future, reversing incurable conditions such as paralysis and blindness.
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Neuralink announced the recent approval to carry out the experiment through a tweet, last month.
In the publication, the company stated that it was working in “close collaboration with the FDA” and that the permission “represents an important first step that will one day allow our technology to help many people".
Approval by regulatory bodies
In the United States, the FDA is the body responsible for regulating this type of activity, acting as if it were Anvisa here in Brazil.
Approval granted by the regulatory agency in May allows Neuralink to conduct human trials of the device.
However, before obtaining marketing authorization for the implant, there is a long way to go, involving several full rounds of testing and safety data collection.
The extent and details of the approved study have not been released by the FDA or Neuralink at this time.
It is known, however, that the agency requires researchers to follow strict ethical protocols to protect the clinical trial participants, including monitoring and reporting any adversities that occur during the experiments.
The company said via Twitter that the recruitment of patients for the clinical trial has not yet started.
About Neuralink
Founded by Elon Musk in 2016, Neuralink is a neurotechnology company that aims to develop interfaces to directly connect the human brain to computers.
The purpose of this development is to enable a faster and more efficient interaction between people and technology, creating an almost symbiotic relationship.
The company's promise is that its first product, a brain chip called simply "Link", will be able to record neural activity and stimulate specific regions of the brain.
With this, the device will help patients with disabilities to recover movement and communication skills, restore vision and establish direct communication with smartphones and computers, only through the power of the thought.
That's because the information collected by the chip will be interpreted by machine learning algorithms and software based on artificial intelligence.
The neural chip, about the size of five stacked coins, is surgically implanted under the skull and expands to different regions of the brain via thousands of tiny electrodes.
Neuralink informs that the surgical procedure will be performed by a robot specially developed just for this purpose.
According to Elon Musk, the surgical implantation of brain chips will become commonplace in the future. He believes that both people with severe disabilities or adverse health conditions and people healthy people will be willing to go through the procedure to install devices with a wide range of goals.
The billionaire believes that these devices will bring the cure for diseases such as obesity, autism, depression or schizophrenia, in addition to the possibility of surfing the internet and even developing a kind of telepathy. The CEO of Neurolink even stated that he would test the chip on himself if necessary.
animal testing
According to Reuters information, the Neuralink is facing an investigation in the United States over allegations of animal welfare violations during its experiments. For that reason, the FDA found it difficult to approve a study carried out in March of this year.
According to Reuters, the tests conducted by Neuralink have been done in a careless and hasty manner, resulting in unnecessary suffering and death.
The complaint was made by the US Department of Agriculture in December last year, due to violations of laws that regulate the treatment of animals in experiments conducted by researchers.