Elon Musk’s Neuralink startup has announced that it has received approval from U.S. regulators to test brain implants in humans.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
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…
— Neuralink (@neuralink) May 25, 2023
“We are pleased to announce that we have received approval from the FDA to launch our first-in-human clinical study,” the company said.
According to Neuralink’s statement, obtaining the approval is an “important step” in developing the brain–computer interface.
Recruitment for the clinical trial has not yet opened.
The goal of Neuralink’s implants is to allow the human brain to interact directly with computers.
“We want to be extremely careful and confident that it [the implant] will work well before testing the device in humans,” Musk said during presentation of the startup in December 2022.
Earlier stages of testing
The company has spent several years testing the technology on animals. Previously, coin-sized implants were implanted in the skulls of monkeys and pigs.
At the startup’s December 2022 presentation, Musk showed several primates playing simple video games or moving a cursor on a screen. According to him, the animals performed actions “by thought” thanks to the implant.
The implanting of the chip is performed with a surgical robot. It replaces part of the skull with a Neuralink disk and inserts thin wires into brain tissue.
According to Musk, the disk records neural activity and transmits the information via Bluetooth to external devices such as smartphones.
However, the company faced criticism from animal-rights activists. According to them, caused “severe suffering” to the test monkeys.
According to the report, from 2017 to 2020, 23 primates were subjected to “inadequate care” as well as invasive and deadly experiments. In addition, scientists used the prohibited substance “bioglue,” which destroys parts of the brain.
According to animal rights groups, only seven of the 23 monkeys survived.
Neuralink disputed the allegations. However, the USDA’s chief inspector launched an investigation into the testing of neural chips on animals.
Later, the U.S. Department of Transportation took an interest in the startup’s activities. The agency accused the company of illegally transporting neural implants contaminated with dangerous primate pathogens.
In March, reports said that the FDA denied Neuralink permission to test brain chips in humans.