Fri 26 May 2023:

Elon Musk’s neurotech company, Neuralink, announced Thursday that it has gained Food and Drug Administration approval to undertake its first in-human clinical study.

Neuralink is developing the Link, a brain implant that will allow individuals with severe paralysis to operate external devices using only neural inputs. This suggests that patients suffering from severe degenerative diseases such as ALS may one day be able to communicate with loved ones by moving cursors and typing with their minds.

Neuralink said clearance from the US Food and Drug Administration (FDA) for its first in-human clinical study is “an important first step” for its technology, which is intended to let brains interface directly with computers.

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study,” Neuralink said in a post on Musk-run Twitter.

“This is the result of incredible work by the Neuralink team in close collaboration with the FDA.”

Recruitment for a clinical trial is not yet open, according to Neuralink.

 “We’ve been working hard to be ready for our first human (implant), and obviously we want to be extremely careful and certain that it will work well before putting a device in a human,” he said at the time.

 In July 2019, Musk vowed that Neuralink would be able to perform its first tests on humans in 2020.

Product prototypes, which are the size of a coin, have been implanted in the skulls of monkeys, demonstrations by the startup showed.

At the Neuralink presentation, the company showed several monkeys “playing” basic video games or moving a cursor on a screen through their Neuralink implant.

Musk said the company would try to use the implants to restore vision and mobility in humans who had lost such abilities.

“We would initially enable someone who has almost no ability to operate their muscles… and enable them to operate their phone faster than someone who has working hands,” he said.

Beyond the potential to treat neurological diseases, Musk’s ultimate goal is to ensure that humans are not intellectually overwhelmed by artificial intelligence, he said.

Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But receiving FDA approval for a commercial medical device is no small task — it requires companies 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.

Other companies working on similar systems include Synchron, which announced in July that it had implanted the first brain-machine interface in the United States.

Activists have criticized Neuralink for its alleged handling of animals. The Physicians Committee for Responsible Medicine, an anti-animal testing organization, has repeatedly urged Musk to share information about monkey trials that resulted in internal bleeding, paralysis, chronic infections, seizures, escalating psychological health, and death.

SOURCE: INDEPENDENT PRESS AND NEWS AGENCIES