Elon Musk’s startup Neuralink has announced it has received US regulatory approval 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 been approved FDA to launch our first human clinical trial,” the company said.
Obtaining the permit is an “important step” for the development of the brain-computer interface, according to Neuralink.
The clinical trial kit is not yet open.
The purpose of Neuralink implants is to allow the human brain to communicate directly with computers.
“We want to be extremely careful and make sure that he [имплант] will work well before testing the device in humans,” Musk said during presentations startup in December 2022.
Previous testing steps
The company has been testing the technology on animals for several years. Previously, coin-sized implants were placed in the skulls of monkeys and pigs.
At a startup launch in December 2022, Musk showed several primates playing simple video games or moving a cursor on a screen. According to him, the animals performed the actions “with the power of thought” thanks to the implant.
The implantation of the chip takes place with the help of a surgical robot. He replaces part of the skull with a Neuralink disc and inserts thin wires into the brain tissue.
According to Musk, the disk registers neural activity and transmits information via Bluetooth to external devices such as smartphones.
However, the company has faced criticism from animal rights activists. According to them, the company’s researchers caused “strong suffering” to experimental monkeys.
From 2017 to 2020, 23 primates were subjected to “inadequate care” and invasive and lethal experiments, according to the report. In addition, scientists used the banned substance “bio-glue”, which destroys parts of the brain.
According to animal rights activists, out of 23 monkeys, only seven survived.
Neuralink denied the allegations. However, USDA Inspector General launched investigation related to the testing of neurochips on animals.
Later, the US Department of Transportation became interested in the startup’s activities. The agency accused the company of illegally transporting neuroimplants infected with dangerous primate pathogens.
Recall that in March, the media reported that the FDA refused Neuralink in human brain chip testing.
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