Elon Musk’s Neuralink gets US FDA approval for human trials

Neuralink, an American neurotechnology company developing implantable brain–computer interfaces, announced that it has received approval from the US Food and Drug Administration (FDA) to commence human clinical trials.

In our blog post in December 2022, we reported that Elon Musk had hoped that brain chip would be implanted in humans within six months and it has come to pass.

Founded in 2016 by a team of experts including Elon Musk, Max Hodak, Ben Rapoport, Dongjin Seo, Paul Merolla, Philip Sabes, Tim Gardner, Tim Hanson, and Vanessa Tolosa, Neuralink focuses on developing an implantable brain chip that enables the simultaneous recording and stimulation of brain activity. With expertise in neuroscience, biochemistry, and robotics, Neuralink aims to harness the chip’s potential for medical applications, particularly in the treatment of severe spinal cord injuries and neurological disorders.

The computer chip consists of a tiny device and electrode-laced wires, along with a robot that carves out a piece of a person’s skull and implants it into the brain.

According to the company in a tweet, “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.”

It however added that “it is not recruiting for the trial yet and said more details would be available soon.”

The FDA also acknowledged that the agency cleared Neuralink to use its brain implant and surgical robot for trials on patients.

This is a huge relief for the company as its earlier bid to start clinical trials was rejected by the FDA. The company has also been accused of being abusive toward its research animals and violating transportation rules by shipping implants contaminated with monkey tissue and pathogens.

Neuralink showcased the brain implants in pigs in 2020 when he hung out with a passel of Yucatan swine at an event at Neuralink’s headquarters in Fremont, California. In 2021, the company introduced us to Pager, a nine year old Macaque, who was playing MindPong with his Neuralink.

As much as the technology has awesome possibilities for mankind, Neuralink will undoubtedly encounter rigorous scrutiny from the FDA to ensure the safety and reliability of their devices. Furthermore, they will grapple with ethical and security concerns arising from a technology that potentially provides cognitive advantages to individuals with brain implants.