Elon Musk Gearing To Hack Brains As Neuralink Is Approved For Human Testing

The FDA Greenlights Elon Musk’s Neuralink For Human Trials

On Thursday 25th May, Neuralink announced that it had received regulatory approval to proceed with the first clinical trial of their experimental devices on humans.

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!” Neuralink announced on Twitter. Neuralink called the development “an important first step that one day will allow our technology to help many people.”

Their leader, tech mogul Elon Musk, was quick to retweet the post as well as send a congratulatory tweet that read, “Congratulations Neuralink team!”

The FDA which is known to remain tight-lipped, especially on matters about clinical trials involving humans, acknowledged the approval on Friday.

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“The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption … for its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device,” an FDA spokesperson revealed in a statement.

What Is Neuralink?

Neuralink is a brain implant company founded by Elon Musk in 2016. According to its website, the company aims to connect humans and computers. This will be done through microchips designed by the company.

The technology that Neuralink aims to develop has the potential to restore functions such as vision as well as end or manage paralysis and debilitating conditions like amyotrophic lateral sclerosis.

“The idea is to allow these chips to record the electrical signals that the brain produces, process them in real-time – that is as they are produced – and send the information via Bluetooth to an app on a mobile device.”

These are the words of Senior Lecturer in Electronic Engineering at Leeds Beckett University, Dr. Roz Wyatt-Millington while speaking to Newsround.

How Close Is The Finished Product?

The company has exclusively used animals for studies up until this point. According to Reuters, since 2018, the company has killed around 1,500 animals, including over 280 sheep, pigs, and monkeys in experiments.

The US Food and Drug Administration’s (FDA) approval is a significant turning point for the business.

Prior to this official approval, Musk has severally predicted that Musk was ‘soon’ going to start human trials. Last year, he applied for approval by the FDA but the agency denied the request on the grounds of safety issues.

The implant’s lithium battery, the potential for the implant wires to move inside the brain, and the difficulty of securely removing the device without injuring brain tissue were some of the main problems.

Despite the approval, it remains unclear when Neuralink’s clinical trials might begin. Only individuals with specific problems, such as paralysis, blindness, deafness, or the inability to communicate, are allowed to enroll, according to a patient registry on Neuralink’s website.

The brain is a very sensitive organ, so planning for anything to be attached to it or put inside it needs to be done extremely carefully. It will therefore take quite a while for the final product to be ready so as the BBC put it, ‘don’t hold your breath.’

While Elon-backed Neuralinked might receive most of the traction and publicity, other companies are developing this technology too. This includes Blackrock Neurotech and Synchron who also have FDA approval to test their product in humans. So far, at least 42 people globally have had brain-computer implants.