Elon Musk announced that his brain-computer interface (BCI) startup, Neuralink, has implanted a device in a third person. Neuralink is among several businesses attempting to link the human nervous system to machines.
“We have… three humans with Neuralinks, and all are working well,” Musk said during a Las Vegas event streamed on his social media platform, X.
Since the first implant nearly a year ago, Neuralink has improved its devices by enhancing electrodes, increasing bandwidth, and extending battery life. Musk also stated that the company plans to implant these experimental devices in 20 to 30 additional individuals this year.
Details about the third patient were not disclosed, but updates on prior recipients were shared:
Although Neuralink draws significant attention, many other companies and academic teams are developing similar technology. For example, two 2022 studies published in the New England Journal of Medicine demonstrated how BCIs improved communication for individuals with ALS.
Who’s Developing BCIs?
Currently, more than 45 clinical trials involving BCIs are underway in the United States. These efforts aim to treat brain diseases, aid recovery from injuries, and explore additional applications.
Rajesh Rao, co-director of the University of Washington’s Center for Neurotechnology, highlighted key advancements in the field. Numerous research labs have already shown that BCIs can provide highly accurate control over computer cursors.
Rao noted two unique aspects of Neuralink’s approach:
However, Rao pointed out that other companies, including Synchron, Blackrock Neurotech, and Onward Medical, are conducting trials using less invasive or more adaptable methods, which sometimes combine stimulation and neural recording.
Marco Baptista, chief scientific officer of the Christopher & Dana Reeve Foundation, described BCI technology as “very exciting” and promising for individuals with paralysis.
Baptista emphasized the importance of clinical trials to determine which strategies will be most successful. “It’s a little early to know,” he said.
Although Neuralink has not received funding from his foundation, Baptista mentioned that the organization supports research teams by providing funds and expertise. He acknowledged the high-risk, high-reward nature of BCI research, stating, “We don’t know how safe it’s going to be. We don’t know how feasible it will be.”
In 2023, Neuralink announced that it had received U.S. regulatory approval to begin human testing of its device.
According to Dr. Rita Redberg, a cardiologist at the University of California, San Francisco, high-risk medical devices like Neuralink’s require an investigational device exemption from the FDA. This exemption allows for clinical testing prior to market approval.
While Neuralink claims to have obtained this exemption, the FDA has not confirmed these claims or disclosed information about the study. Redberg explained that the FDA oversees every stage of the process, from patient recruitment to data analysis, with a focus on safety.
All human research must also be approved by Institutional Review Boards (IRBs), which are also known as ethical review boards or independent ethics committees. These boards ensure that:
IRBs must include at least one non-scientist and one individual unaffiliated with the organization conducting the research. “They are responsible for ensuring that patients are aware of the appropriate risk and benefit before enrolling,” Redberg said.
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