Elon Musk’s brain-implant firm Neuralink announced that the Food and Drug Administration (FDA) has approved its first-in-human clinical trial, a significant step after previous difficulties in obtaining approval.
The FDA approval “represents an important first step that will one day allow our technology to help many people,” according to a tweet from Neuralink. It did not elaborate on the study’s objectives, just stating that it was not yet recruiting and that further information would be forthcoming soon.
Musk anticipates brain implants curing diseases such as obesity, autism, depression, and schizophrenia, as well as facilitating web browsing and telepathy. He made headlines late last year when he declared he was so sure the gadgets were safe that he would implant them in his children.
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The controversial billionaire has repeatedly touted that Neuralink will commence human testing at least four times since 2019. However, the corporation only requested FDA permission in early 2022, and the application was apparently rejected by the agency.
The latest of his predictions was in December 2022, saying he is confident it would begin human clinical trials of the wireless brain chip in six months. The FDA approval validated this latest prediction.
Musk’s company prematurely began looking for a partner for its human trials back in late March. The brain implant firm, which aims to provide a cure for paralysis and blindness, is said to be in talks with Barrow Neurological Institute, a Phoenix, Arizona-based neurological disease treatment and research organization. Although the company has also discussed the possibility of partnering with other centers to carry out the complex process of testing the brain-computer interface (BCI) on its intended users.
The implant would require drilling into the brain to attach the BCI directly to the brain tissue, a novel process that had prevented the company from receiving FDA approval for testing. At least two other BCI implants using less invasive approaches have already begun human trials.
According to the employees, the FDA had raised various problems with Neuralink that needed to be rectified before human trials could be approved. The gadget’s lithium battery, the potential of the implant’s wires moving within the brain, and the difficulties of properly retrieving the device without injuring brain tissue were all major issues.
Neuralink, which was created in 2016, has been the focus of various federal investigations. In May, lawmakers in the United States urged regulators to look into whether the composition of a panel monitoring animal research at Neuralink contributed to botched and rushed trials.
Separately, the Department of Transportation is investigating whether Neuralink carried harmful infections on chips extracted from monkey brains without necessary containment precautions. The Department of Agriculture’s Office of Inspector General is also looking into Neuralink for alleged animal-welfare breaches. This investigation has also looked at the USDA’s oversight of Neuralink.
Information for this briefing was found via Reuters and the sources and companies mentioned. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
