Neuralink receives FDA authorisation to explore human brain implants
The US Food and Drug Administration (FDA) has given Neural ink, Elon Musk’s brain implant business, permission to begin its first-in-human clinical research.
Since the start of 2019, Musk has made at least four predictions that his medical device business will soon begin human trials of a brain implant to treat fatal conditions including blindness and paralysis.
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However, the business, which was created in 2016, didn’t apply for FDA approval until early 2022, and when it did, the government denied the request, seven present and former workers told Reuters in March.
The FDA’s clearance comes after US senators urged authorities earlier this month to look into whether the composition of a panel in charge of Neuralink’s animal testing played a role in the hurried and poorly executed studies. Federal investigations have already been conducted on Neuralink.
On December 5, Reuters reported that the USDA’s Inspector General was looking into possible breaches of the Animal Welfare Act, which regulates how researchers handle and test particular species of animals, at the request of a federal prosecutor.
The investigation has also looked at how Neuralink was managed by the USDA.
In a tweet on Thursday, Neuralink said that the company is not presently taking on new patients for clinical testing.
“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” Neuralink stated in a tweet on Thursday.
Neuralink is working on a brain implant that it thinks can restore movement to paraplegic patients and treat other neurological conditions.
A request for comment from Reuters was not immediately answered by the FDA.