Although Musk did not specify how many patients his company will implant and for how long, he said, "It appears that the first case will take place later this year." Musk is also the CEO of electric vehicle manufacturer Tesla, the social media platform Twitter, and the aerospace company SpaceX.
Last month, Neuralink announced that it had received permission from the U.S. Food and Drug Administration (FDA) for its first clinical trial on humans, a crucial milestone for the start-up that is currently under investigation by U.S. authorities due to its handling of animal experiments. The FDA confirmed in a previous statement to Reuters that it has approved Neuralink to use its brain implant and surgical robot for experiments but declined to provide further details.
If Neuralink can demonstrate that the device is safe for humans, it will still take several years, possibly more than a decade, before the start-up obtains approval for commercial use, according to experts who spoke with Reuters. The company is also competing with other neurotech companies that have already implanted their devices in humans.
However, Musk has previously missed deadlines regarding Neuralink. Since 2019, he has predicted at least four times that the company would soon begin clinical trials on humans.
According to Reuters, Neuralink, founded in 2016, initially applied for FDA approval in early 2022 but was rejected due to dozens of safety concerns. Some of the issues involved the device's lithium battery, the possibility of the implant's wires moving in the brain, and the challenge of safely removing the device without causing damage to brain tissue.
Neuralink is also under federal supervision following Reuters reports on animal experiments conducted by the company. Last year, Neuralink employees told Reuters that the company was rushing and improperly conducting operations on monkeys, pigs, and sheep, resulting in more unnecessary animal deaths.
Elon Musk expects first human implantation of Neuralink later this year
Wednesday, June 21, 2023
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