Neuralink, a neurotechnology company, has received the nod from US Food and Drug Administration (FDA) to proceed with first-in-human clinical trials.
In a tweet, the company said: “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!”
Neuralink, which was founded by Elon Musk, is developing a brain implant called the Link to help people with severe paralysis in operating external devices through neural signals.
If successful, this technology has the potential to restore communication abilities for patients suffering from degenerative diseases such as ALS by allowing them to interact via cursor movements and mind-controlled typing.
“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,” the company’s tweet read.
The FDA stated that Neuralink was permitted to utilise its brain implant and surgical robot for patient studies, according to Reuters.
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By GlobalDataBoth the FDA and Neuralink did not provide other details, such as the extent of the approved trial.
Neuralink stated that the recruitment for the clinical trial is not open yet, and it will announce the details soon.
The key development comes as the company faces probes by the US government.
According to the news agency, the Department of Transportation is investigating the potential illegal transportation of hazardous pathogens on chips extracted from monkey brains without appropriate containment protocols.
In addition, Neuralink is under scrutiny by the US Department of Agriculture’s Office of Inspector General for potential violations related to animal welfare, the report added.
Requests for comments from the news agency were not answered by Musk or Neuralink.