Elon Musk’s brain-implant company, Neuralink, has received approval from the US Food and Drug Administration (FDA) to conduct its first tests on humans.

Neuralink aims to revolutionise the field of neurotechnology by developing a high-bandwidth, implantable device that allows the brain to interface directly with computers and other external devices.

“First @Neuralink product will enable someone with paralysis to use a smartphone with their mind faster than someone using thumbs,” Musk said in April 2021.

Its device would be embedded into a person’s brain and record brain activity for potential stimulation.

The company envisions a future where individuals with neurological conditions can regain lost functionality and even enhance cognitive abilities through the seamless integration of technology with the human brain.

The company is not the first to get human testing. In fact, direct competitor Synchron had acquired testing a few years prior and less ambitious neurotechnologies have been available for decades.

“In terms of first in human, Neuralink is almost two decades behind,” said JoJo Platt, a neurotech strategist.

Neuralink first became public in 2017 and had promised to start human trials by 2020 and 2022 but was unsuccessful.

The first promising result came in animal trials in 2020. Neuralink showed off one of its chips embedded in a pig named Gertrude. The chip was moderately successful as it was able to record neural activity that indicated when the pig snuffled food and when it started walking.

Neuralink announced it had raised a $205 million series C funding round from investors including Google’s GV

Other trials on monkeys had continued since. A video in 2021 that showed a macaque playing a simple videogame after being implanted with a brain chip.

Not everyone is a fan

Since the inception of the company, many have criticised the broad claims made by Musk.

None of the tech Neuralink has showcased so far has been particularly groundbreaking and most of it is built on research from 2002 about neural communication, but neuroscientists are impressed with how well it’s been able to bundle up existing technologies.

“In terms of their technology, 1,024 channels is not that impressive these days, but the electronics to relay them wirelessly is state-of-the-art, and the robotic implantation is nice,” Andrew Jackson, an expert in neural interfaces at Newcastle University, said.

“This is solid engineering, but mediocre neuroscience,” he said.

Concerns were also raised about animal welfare by neuroscientists worldwide. Prof. Andrew Jackson was a staunch critic of Neuralink after it got animal testing approval.

“Even if the technology doesn’t do anything more than we’re able to do at the moment — in terms of number of channels or whatever — just from a welfare aspect for the animals, I think if you can do experiments with something that doesn’t involve wires coming through the skin, that’s going to improve the welfare of animals,” he said.

However, animal rights groups have submitted multiple complaints that Neuralink has mistreated its subjects. Neuralink denies these claims.

How it works?

The chip being developed is about the size of a coin.

It sits behind the ear with electrodes threading into the brain. These array of thin wires make their way into the skill, with each roughly 20 times smaller than a strand of hair.

The wires are equipped with 1,024 electrodes, which are able to monitor brain activity and, theoretically, electrically stimulate the brain. The chip transmits this data wirelessly via the chip to computers, where rearchers can study it.

By establishing a two-way communication pathway between the brain and external devices, Neuralink’s technology holds tremendous promise for treating neurological disorders, enabling brain-controlled prosthetics, and augmenting human capabilities.

What is next?

Neuralink’s success in obtaining FDA approval underscores the company’s commitment to advancing the frontiers of neurotechnology and its potential to revolutionise the lives of millions of people affected by neurological disorders.

As the progress of the trial, the scientific community eagerly anticipates the results and subsequent advancements in the field of brain-computer interfaces.

While it may still be some time before Neuralink’s technology becomes widely available, the approval from the FDA marks a crucial step toward the realisation of this visionary project.