Elon Musk’s Neuralink gets FDA approval for in-human study

Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study.

Neuralink is constructing a brain implant called the Link, which goals to assist patients with severe paralysis control external technologies using only neural signals. This implies patients with severe degenerative diseases like ALS could eventually regain their ability to speak with family members by moving cursors and typing with their minds.

“That is the results of incredible work by the Neuralink team in close collaboration with the FDA and represents a crucial first step that can at some point allow our technology to assist many individuals,” the corporate wrote in a tweet.

The FDA and Neuralink didn’t immediately reply to CNBC’s request for comment. The extent of the approved trial just isn’t known. Neuralink said in a tweet that patient recruitment for its clinical trial just isn’t open yet.

Neuralink is a component of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Neuralink is maybe the best-known name within the space because of the high profile of Musk, who can also be the CEO of Tesla, SpaceX and Twitter.

Scientists have been studying BCI technology for many years, and several other firms have developed promising systems that they hope to bring to market. But receiving FDA approval for a industrial medical device is not any small task — it requires firms to successfully conduct several extremely thorough rounds of testing and data safety collection.

No BCI company has managed to clinch the FDA’s final seal of approval. But by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market.

Neuralink’s BCI would require patients to undergo invasive brain surgery. Its system centers across the Link, a small circular implant that processes and translates neural signals. The Link is connected to a series of thin, flexible threads inserted directly into the brain tissue where they detect neural signals.

Patients with Neuralink devices will learn to regulate it using the Neuralink app. Patients will then have the option to regulate external mice and keyboards through a Bluetooth connection, in line with the company’s website.

The FDA’s approval for an in-human study is a major win for Neuralink after a series of recent hurdles at the corporate. In February, the U.S. Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink for allegedly packaging and transporting contaminated hardware in an unsafe manner. Reuters reported in March that the FDA had rejected Neuralink’s application for human trials, and reportedly outlined “dozens” of issues the corporate needed to deal with.

Neuralink has also come under fire from activist groups for its alleged treatment of animals. The Physician’s Committee for Responsible Medicine, which advocates against animal testing, has repeatedly called on Musk to release details about experiments on monkeys that had resulted in internal bleeding, paralysis, chronic infections, seizures, declining psychological health and death.

A representative for PCRM didn’t immediately reply to CNBC’s request for comment.

Along with helping patients with paralysis, experts imagine BCIs could someday help treat maladies like blindness and mental illness. Musk has expressed his intent for Neuralink to explore these future use cases, in addition to potential applications for healthy people.

At a “show and tell” recruitment event late last yr, Musk even claimed he plans to someday receive certainly one of Neuralink’s implants himself.

“You might have a Neuralink device implanted at once and you would not even know,” Musk said on the time. “In reality, in certainly one of these demos, I’ll.”