
California. The green light was given on Thursday Federal Food and Drug Administration (FDA) brain implant company Neuralinkhis property Elon Muskto begin its first human clinical trial. The company has already submitted several applications to the service, but so far has received negative responses.
Since 2019, Musk has spoken at least four times about his company’s intention to conduct human clinical trials of the implant. The device, according to its creators, is able to fight blindness and paralysis. The company, founded in 2016, unsuccessfully sought FDA approval in early 2022.
At the time, the FDA indicated that the company needed to resolve serious issues with its device before placing it on people. The agency drew attention to issues with the implant’s lithium battery, the ability to move the device’s wires inside the brain, and the problem of safely removing it without damaging brain tissue.
Thursday’s approval came as US lawmakers are asking regulators to investigate whether a panel overseeing animal trials of the implant failed in its job of allowing sketchy experiments with questionable results.
Last year, the FDA Inspector General launched an investigation into Neuralink by order of a federal appeals court for possible violations of animal welfare laws governing the treatment of laboratory animals. Musk’s company has already killed 1,500 animals, including sheep, pigs and monkeys, in experiments since 2018.
The investigation also concerns the FDA’s own oversight of Neuralink’s research activities. In a Twitter post also owned by Elon Musk, the company clarified that it is not yet ready to conduct a clinical trial with patients.
“The approval is the result of the incredible work of the Neuralink team in close collaboration with the FDA and represents an important first step in developing a technology that will one day help many people,” the company tweeted.
In recent years, Musk has unveiled ambitious plans for Neuralink. His goal is to mass-produce an implant that can be quickly installed in medical centers rather than in hospitals. Last year, a controversial South African businessman said he was so confident in Neuralink’s device that he was willing to implant it in his children’s brains.
Source: Kathimerini

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