Elon Musk’s Neuralink Receives FDA Approval

By Mimi Nguyen Lai

Elon Musk’s neurotechnology company Neuralink announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) to conduct clinical research on human brain implants.

This is the first human-to-human clinical study for the company.

“This is the result of the incredible work of 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 said in a statement.

“Recruitment for our clinical trial is not yet open. We will announce more information on this soon.” he added, without giving further details about the trial.

Musk, in response. wrote On Twitter: “Congratulations to the Neuralink team!”

Musk’s ambitions

Neuralink was founded in 2016 and is based in San Francisco. According to its website, Neuralink aims to create “the first neural implant that lets you control a computer or mobile device wherever you go.”

Musk has previously said he hopes the company will one day help people with debilitating conditions, including severe spinal cord injuries and amyotrophic lateral sclerosis.

Musk also believes that brain implants could help with other diseases such as obesity, autism, depression and schizophrenia.

He’s also optimistic that technology can enable web browsing and telemetry.

Ethical and other concerns

The company started testing animal brain implants back in 2019.

By April 2021, Neuralink released a video showing a 9-year-old macaque named Pager playing computer games with a neural implant implanted in his brain.

Neuralink also showed off a robot that can handle the most delicate parts of brain implant surgery, a pig whose legs can be remotely controlled by a computer, and a monkey with a brain implant that made it see flashes of light.

Musk appeared in late 2022 when he said the safety of brain implants was such that he would be willing to implant them in his children.

Experts told The Epoch Times that there could be ethical, safety, security, privacy and even philosophical issues when it comes to Neuralink’s goals of having healthy people interact directly with the technology through thought.

Federal investigations

Neuralink has been the subject of several federal investigations.

In February, the US Department of Transportation announced it was investigating whether the company transported potentially dangerous pathogens while removing brain chips from monkey brains without properly containing them, in violation of federal law.

Separately, Neuralink is being investigated by the US Department of Agriculture (USDA) Office of Inspector General for possible violations of the Animal Welfare Act. The investigation also examined how the USDA oversees the company.

Democratic lawmakers in Congress urged the USDA in May to investigate how Neuralink oversees its experiments and whether there are conflicts of interest within the panel responsible for overseeing animal testing.

Specifically, the lawmakers said (pdf) that a May 4 Reuters report presented “new allegations” that require USDA and the Animal and Plant Health Inspection Service (APHIS) inspector general to investigate the company for “possible conflicts of interest.” for”: Members of the Institutional Animal Care and Use Committee (IACUC).

Katabella Roberts and Reuters contributed to this report.

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