Neuralink Gets Food & Drug Administration Approval: How This Tiny Brain Implant Chip Could Transform Medical Science

Elon Musk envisions that brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy

New Delhi: The neurotech startup Neuralink on Thursday announced that it has received approval from Food and Drug Administration (FDA) to conduct its first in-human clinical study.

The company co-founded by billionaire Elon Musk is building a brain implant called the Link, which aims to help patients with severe paralysis control external technologies using only neural signals. If successful, people with?severe degenerative diseases like ALS could eventually regain their ability to communicate with loved ones by moving cursors and typing with their minds.

“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 wrote in a tweet.

However, the extent of the approved trial is unknown. Both FDA and Neuralink have not responded to media queries.?Neuralink said in a tweet that patient recruitment for its clinical trial is not open yet.

Neuralink Human Trials – Key Points

1. ?A brain-computer interface (BCI) system deciphers brain signals and translates them into commands using external technologies.?Neuralink is part of the emerging BCI industry. The company is perhaps the best-known name in the industry, thanks to the high profile of Musk, who is also the CEO of Tesla, SpaceX and Twitter.
2. The BCI technology is one that scientists have been studying for decades with several companies developing promising systems hoping to bring to market. Receiving FDA approval means the company has gone through several rounds of testing and data safety collection.
3. Elon Musk envisions that brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy. One of the many instances where Musk made headlines last year was when he said?he was so confident in the devices’ safety that he would be willing to implant them in his children.
4. Neuralink is the one and only 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.
5. In order to activate the interface provided by Neuralink, one needs to undergo an invasive brain surgery. Neuralink’s system centers around 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.
6. There’s a Neuralink app that should be used by?patients with Neuralink devices to control it. Patients will then be able to control external mice and keyboards through a Bluetooth connection, according to the company’s website.
7. The FDA approval that Neuralink has received is significant in multiple fronts considering the series of hurdles that the company had to go through recently. 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. In March, the FDA had rejected Neuralink’s application for human trials, and reportedly outlined “dozens” of issues the company needed to address, as per a Reuters report.
8. Earlier, the FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees quoted by Reuters. Major issues involved the lithium battery of the device, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.
9. Neuralink has also faced numerous criticisms 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.
10. In addition to helping patients with paralysis, experts believe BCIs could someday help treat maladies like blindness and mental illness. Musk has expressed his intent for Neuralink to explore these future use cases, as well as potential applications for healthy people.

During an event late last year, Elon Musk did claim that he plans to someday receive one of Neuralink’s implants himself.

“You could have a Neuralink device implanted right now and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”