Economic Observer Network reporter Zhang LingOn May 25, local time in Los Angeles, the United States, Musk’s brain-computer interface company Neuralink announced a major development: the company has obtained approval from the U.S. Food and Drug Administration (FDA) approved that its implantable brain-computer interface device (BCI) can be used in clinical studies on humans.
Neuralink was founded in 2016. It is one of the two brain-computer interface companies that has raised more than 200 million US dollars in the world. It is also the most watched star company in the field of brain-computer interface. Neuralink claims that obtaining FDA approval to conduct the first human clinical trial is an "important milestone" in the success of brain-computer interface technology.
A medically implantable brain-computer interface device that can read electrical signals from the brain after being implanted in the brain has been approved for human trials. Neuralink hopes that this device can help paralyzed people walk again. Musk has also publicly stated that this technology will be used to help visually impaired and mobility-challenged people restore their vision and mobility.
Since 2019, Neuralink has successfully implanted brain-computer interface chips into the brains of mice, pigs and monkeys. Neuralink is being investigated for violating the Animal Welfare Act because 15 of the 23 monkeys involved in the experiment have died.
Musk has repeatedly predicted that the FDA will soon approve Neuralink for human trials. However, in early 2022, the FDA rejected its human clinical trial application due to concerns about the safety of brain implant device trials. In December 2022, Musk shared a video of a monkey controlling a mouse and keyboard typing with his thoughts. He also said that Neuralink is expected to obtain FDA approval for human trials within 6 months.
Ma Yongjie, the surgeon in charge of the first interventional brain-computer interface animal test in China and the chief physician of neurosurgery at Xuanwu Hospital, told the Economic Observer Network reporter that 3-5 years ago, people regarded Musk as a crazy person, but as time passed, The FDA has approved human trials of brain-computer interfaces, and this technology can indeed be brought into reality.
Neuralink was approved to conduct human trials. Liu Bing, chief scientist of Chinese brain-computer interface company Rouling Technology, was not surprised: "Even if it is not approved this time, it will be approved next time. Controversies will always exist, and risks must be carefully assessed, but We will definitely go in this direction.”
Only Xinwei Medical (06609.HK) is directly involved in brain-computer interface research and development among Chinese listed companies. Zhang Han, chief financial officer of Xinwei Medical, told the Economic Observer Network reporter that Neuralink's approval to conduct human trials is good news for the entire brain-computer interface industry. It will allow the industry to attract more capital and industry attention and promote China's brain-computer interface. Interfaces moving forward.
Currently, Neuralink has not yet begun recruiting human participants, and the FDA has not publicly disclosed details such as the research location and number of participants.
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