Elon Musk's Neuralink says it has US FDA approval for human trials

Neuralink, Elon Musk’s brain-implant company, said it received approval from the US Food and Drug Administration to conduct human clinical trials.

“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 Thursday in a tweet.

The FDA and Neuralink did not immediately respond to a request for comment. The startup is developing a small device that will link the brain to a computer, consisting of electrode-laced wires. Placing the device requires drilling into the skull.

The approval is a major step for Neuralink, which was founded in 2016. The startup has attracted some top neuroscientists to work on its brain implant, although many have since moved on to other companies or academia. For many years, Musk has said that the company was close to FDA approval for in-human trials, but the goal had been elusive.

Neuralink’s device could help people with paralysis or traumatic brain injuries communicate and control a computer using only their thoughts. Eventually, aside from helping people who are sick, Musk has hypothesized that the device could enable humankind to keep up with advances being made by artificial intelligence.

Neuralink isn’t the first brain-computer interface company to enter human trials, and the field has become competitive since the company’s founding. For example, Synchron has already enrolled its first US patient in a clinical trial, putting the company’s implant on a path toward possible regulatory approval for wider use in people with paralysis. Synchron’s device is less invasive than Neuralink’s, and works using a different technology.

Musk’s startup has raised alarms with some animal rights groups for its testing on primates. The US Transportation Department began an investigation into the company after an animal advocacy group said it obtained emails suggesting the startup did not follow proper procedure when shipping possibly hazardous materials. 

ALL IN THE HEAD
 

What is Neuralink?
 

Founded by Elon Musk, Neuralink is an American neurotechnology company. Its device has a chip that processes and transmits neural signals that could be transmitted to a computer or a phone

Why connect our brains to computers?

• To be able to learn things faster, have instant access to information, and communicate with others using only thoughts 
• The company believes its device will eventually be able to restore neural activity inside the body, allowing those with spinal cord injuries to move limbs

CONTROVERSY AROUND ANIMAL TESTING

The company is facing a federal probe for potential animal-welfare violations. In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018

Source: Agencies