Elon Musk’s Neuralink Gets FDA Approval to Study Brain Implants in Humans

Illustration by The Epoch Times. Aleksandra Sova/Shutterstock, Carina Johansen/NTB/AFP via Getty Images

Elon Musks’s neurotechnology company Neuralink announced on Thursday it has obtained approval from the U.S. Food and Drug Administration (FDA) to carry out a clinical study of brain implants in humans.

It marks the first in-human clinical study for the company.

“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 said in a statement.

“Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!” it added, without providing further details about the trial.

Musk, in response, wrote on Twitter: “Congratulations Neuralink team!”

Musk Ambitions

Neuralink was founded in 2016 and is based in San Francisco. According to its website, Neuralink seeks to build “the first neural implant that will let you control a computer or mobile device anywhere you go.”

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

Musk also believes brain implants could have potential to help other conditions including obesity, autism, depression, and schizophrenia.

He is also optimistic the technology could enable web browsing and telepathy.

Ethical and Other Concerns

The company began testing brain implants in animals back in 2019.

By April 2021, Neuralink published a video showing a 9-year-old macaque named Pager playing computer games via a neural implant that was inserted into its brain.

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

Musk made headlines late in 2022 when he said the brain implants’ safety is such that he'd be willing to implant them in his children.

Experts have told The Epoch Times 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 via the mind.

Federal Investigations

Neuralink has been under several federal investigations.

The U.S. Department of Transportation announced in February it is investigating whether the company had transported potentially dangerous pathogens—when removing the brain chips from monkeys’ brains—without proper measures to contain them, which would be in violation of federal law.

Separately, Neuralink is under investigation by the U.S. Department of Agriculture’s (USDA) Office of Inspector General for potentially violating the Animal Welfare Act. The probe was also checking on how the USDA has been overseeing the company.

Democrat congressional lawmakers in May urged the USDA to look into how Neuralink oversaw its experiments and whether there were any conflicts of interest within the panel that was responsible for overseeing animal testing.

Specifically, the lawmakers said (pdf) that a report from Reuters on May 4 presented “a new allegation” that requires the USDA and Animal and Plant Health Inspection Service (APHIS) Inspector General to investigate the company “for possible conflicts of interest among its Institutional Animal Care and Use Committee (IACUC) members.”

Katabella Roberts and Reuters contributed to this report.