Elon Musk can start implanting brain chips in humans as trial gets US approval

Elon Musk’s brain implant company Neuralink can begin testing its chips in humans after it received approval from the US regulator.

The tech company, which hopes to implant tiny chips into people’s brains to treat conditions such as paralysis and blindness, had previously been denied permission for clinical trials because of the associated risks.

Neuralink said clearance from the US Food and Drug Administration (FDA) was “an important first step” in creating the coin-sized chips, which have so far been tested on monkeys and pigs.

The company gave no details about the trial, saying only recruitment for the study was not yet open.

However, there is an option for people in the US with quadriplegia, paraplegia, vision or hearing loss and the inability to speak to sign up to the firm’s “patient registry” on its website.

“We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study,” Neuralink wrote on Twitter on Thursday.

The technology is designed to be threaded into the brain using tiny filaments and harness AI technology to pick up brain activity using a so-called “brain computer interface”.

Mr Musk, 51, previously said the firm had 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”.

US medical regulators were last year said to have “dozens” of concerns over the risks posed by the device. These included fears that tiny electrodes could get lodged in other parts of the brain, which could impair cognitive function or rupture blood vessels.

To help overcome the concerns, Neuralink reportedly launched a collaboration with Barrow Neurological Institute, a Phoenix, Arizona-based neurological disease treatment and research organisation, to help carry out the human trials, sources told US news agency Reuters.

Mr Musk set up Neuralink in 2016, after warning that unless people adapt to combine with computers, humanity risks becoming outsmarted by artificial intelligence. He said under the best of circumstances, humans would be akin to “house cats”.

The disk reportedly registers nerve activity, relaying the information via common Bluetooth wireless signal to a device such as a smartphone.

“It actually fits quite nicely in your skull,” Mr Musk said previously. “It could be under your hair and you wouldn’t know.”

Tests on macaque monkeys have shown the animals “playing” video games or moving a cursor on a screen using only their brains.

Request for investigation

In May, US House Representatives Earl Francis Blumenauer and Adam Schiff, both Democrats, reportedly signed a draft letter to the US Department of Agriculture (USDA) requesting an investigation into how Neuralink oversaw its experiments.

They urged regulators to examine whether the make-up of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.

According to records reviewed by Reuters and sources close to the company’s animal-testing operations, around 1,500 animals, including more than 280 sheep, pigs and monkeys have died following experiments since 2018.

The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.

Neuralink is also under investigation by the US Department of Agriculture’s Office of Inspector General for potential animal welfare violations. This probe has also been looking at the USDA’s oversight of Neuralink.

Neuralink and Mr Musk have not commented on the investigations.