Musk’s brain-computer interface company Neuralink is approved to launch the first human clinical trial | Titanium News

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Titanium Media App News on May 26, This morning, Beijing time, Musk’s brain-computer interface company Neuralink stated on social platforms that the company has obtained approval from the U.S. Food and Drug Administration (FDA) With approval, the first human clinical study of brain implants will be launched, but clinical trial recruitment has not yet begun.

"This is the result of incredible work by the Neuralink team working closely with the FDA and represents an important first step in how our technology will one day help many people," Neuralink said in a tweet.

This means that Neuralink has become the second brain-computer interface company to be approved by the US FDA to enter the first human clinical trial after Synchron. It also indicates that Neuralink is moving towards the commercialization of the "whole brain interface" that Musk hopes to achieve. goal is one step closer.

In fact, Neuralink’s FDA approval process has been full of twists and turns.

Neuralink was founded in 2016. It is committed to the research of brain-computer interface technology. It is developing a brain implant that uses invasive brain-computer interface technology to implant tiny electrodes in the brain and use electric current to Computers interact with brain cells in hopes of helping paralyzed people walk again and curing other neurological diseases.

Musk has predicted for at least the fourth time since 2019 that Neuralink will soon receive FDA approval for human trials. The company's application was rejected in early 2022 because it failed to address safety concerns about the experimental implants. Musk announced in December that Neuralink would begin human clinical trials within the next six months.

• In September 2019, Musk announced that Neuralink had developed the "brain-machine neural mesh" device N1, which attaches more than 3,000 electrodes to flexible filaments, which may enable the brain to control computers. Since then, research on brain-computer interfaces has been pushed into the public eye and has become a current hot topic.
• In August 2020, Musk once again released the latest research results of Neuralink and realized the experiment of implanting a brain-computer interface in pigs: using a coin-sized implanted chip device Link V0.9 and a surgical robot V2, This "coin" device is implanted into the cerebral cortex part of the human skull to complete the implantation of the brain-computer interface. The machine obtains the electrode signals inside the brain and transmits them to mobile phones, computers and other devices, completing data transmission between brain and computer in real time.
• In April 2021, Neuralink went a step further and conducted a brain-computer interface experiment on a macaque named "Pager", enabling a monkey to use only its brain without a game joystick. Use your thoughts to control a computer and play table tennis.
• In December 2022, Musk announced that through multiple device/hardware upgrades, Neuralink has enabled a monkey named Sake to use his brain to control a virtual keyboard to type, completing fast "thought typing". And it is expected to start human clinical trials within the next 6 months.

According to Reuters, the U.S. government has begun investigating Neuralink after the FDA approved it. Earlier this month, U.S. lawmakers urged the U.S. Department of Agriculture and other departments to investigate whether oversight of Neuralink’s animal testing led to innocent animal deaths and rushed experimental results. In December, the U.S. Department of Agriculture’s inspector general began investigating whether Neuralink violated animal welfare laws at the request of federal prosecutors.

Neuralink said in a tweet this morning that the company is not yet open for clinical trials.

Musk once revealed that the next generation of Neuralink products, in addition to the two major products of brain-computer interface chips and electrodes, and surgical robots, the team is developing implants that enter the spinal cord and may restore the movement ability of paralyzed patients, and Vision-restoring eye implants implanted in the visual cortex of two monkeys. Neuralink's goal is to bring light back to those who have lived in darkness for years.

In the seven years since its establishment, Neuralink has completed a total of more than 160 million US dollars (approximately 1.133 billion yuan) in financing, most of which came from Musk himself. Data disclosed by PitchBook in 2020 shows that Neuralink's valuation exceeds US$500 million. Other news shows that as of January this year, Neuralink's expected valuation is as high as US$5.5 billion. (This article was first published on Titanium Media App, author | Lin Zhijia)

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