Neuralink has already received the first approval to test its brain implants on humans.

The company began in 2022 the process with the pharmaceutical regulator to conduct clinical trials of its chip. In the short term, it opens hope for the relief of a range of medical problems, while in the medium term, it represents fuel for transhumanism, a matter that has sparked deep discussions, as it could radically alter human life and the mind.

Neuralink, Elon Musk’s brain chip company, announced it has received the green light from the pharmaceutical regulator to conduct its first human trial. The controversial entrepreneur predicted in December that approval from the Food and Drug Administration (FDA), the agency overseeing products, medicines, and surgical procedures in the U.S., would arrive during the first half of this year. He was right, although the approval wasn’t easy, as they were rejected last year. The company, founded in 2016, reported that this is the first step that will allow its technology to “help many people.”

“Recruitment is not yet open for our clinical trial,” the company posted on Twitter, promising more information in the coming days. Neuralink has been raising expectations about its advancements for several years. In 2020, Musk stated in a presentation that the chips manufactured by the company could cure some types of paralysis and certain cases of insomnia. The controversial magnate, who has often been careless with his words, even claimed that the device could give users “superhuman” vision. At that time, they showcased one of their first implants, in a pig.

A year later, in 2021, Neuralink made one of its most viral presentations. A monkey, Pager, appeared in front of a TV and attentively watched what was happening on the screen, a game of Pong. The primate controlled the game just by looking, thanks to a pair of semiconductors the size of a 25-cent coin implanted in both hemispheres of its brain.

Musk said a few months ago that they had started “extremely careful” paperwork with the FDA and were working with the agency. “I think probably in six months we will be able to put our first Neuralink in a human,” said the controversial billionaire, who recently helped Florida Governor Ron DeSantis launch his 2024 U.S. presidential campaign on Twitter.

Before this, Musk had claimed at least three times since 2019 that he was seeking FDA approval for clinical trials in humans. But it wasn’t until 2022 that the company started the legal process with the regulator. According to Reuters, this first request was rejected by the FDA authorities shortly after being submitted. The regulator was concerned about the safety of the battery used in the semiconductor, which is made of lithium. There were also worries that the small cables extending from the brain could be invasive in other areas of the skull. Finally, the regulators also raised questions about the implications of removing the chip and whether this process could damage brain tissue.

A report from the British agency cited experts who doubted whether Neuralink could quickly address the concerns raised by the government agency, which had the final say in 85% of human trials conducted in the last three years. “Neuralink doesn’t seem to have the necessary experience or mindset to launch this on the market soon,” said a neural engineer quoted in the piece published in March.

Neuralink is not the only company preparing to conduct the first human trials of its technology. One of its main competitors, Paradromics, is also seeking approval. Founded in 2015, the Austin-based company has made giant strides with its implants and has grown its team to become a rising player with around fifty researchers. Its product, called Connexus Direct Data, promises patients with paralysis to regain some communication skills.

The promising profile of its technology led the FDA to include it in its select program for cutting-edge devices, where 32 initiatives receive a faster review process, as they could benefit patients in their treatments and diagnoses. Another company competing in the emerging brain implant industry is Synchron. The companies differ in the size, weight, and functioning of their semiconductors and in the surgical methods for implantation. However, all see the future and the benefits they could bring to millions of people with optimism.