The US regulator has refused to issue permission to Elon Musk's company to test brain implants on humans, Reuters writes in an investigation into the work of Neuralink. The company submitted an application to the Food and Drug Administration (FDA) in early 2022, but it was rejected, several former and current employees told the agency.
The fact that Neuralink plans to test brain chips on humans has been reported by Musk several times since 2019. According to the entrepreneur, the implants developed by the company can potentially help cure diseases such as paralysis and blindness. As a short-term goal, Neuralink representatives called the creation of a mechanism that will allow paralyzed patients to communicate through computer text without typing it.
The FDA, however, felt the risks were now too great. In justification for the refusal, the regulator listed dozens of problems that Neuralink must solve before moving on to human trials. The device's lithium battery was the biggest concern, Reuters sources said; the possibility that the implant's tiny wires could migrate to other parts of the brain; the question is how to remove the device without damaging the brain tissue, and is it possible at all. The agency’s interlocutors said that a year after the FDA’s refusal, the company still had not solved the tasks. Nevertheless, Musk promised in November that Neuralink would receive regulatory approval in the spring of 2023.
Musk and other Neuralink officials, as well as the FDA, declined to comment. Over the past three years, the FDA has approved two-thirds of all applications for human trials of various devices on the first try, according to official FDA figures.
Neuralink was founded in 2016. Neuralink's estimated value is more than $1 billion, according to people familiar with the private valuation. In April 2021, the company showed a monkey that had a chip implanted in the motor cortex of both hemispheres of the brain. The animal could control the cursor on the computer monitor with the power of thought and play ping-pong in this way: the cursor moved depending on patterns of neural activity emerging in the motor cortex of the brain.
In 2022, Reuters reported that the US government had opened an investigation into Neuralink's handling of animal testing. Nothing is known about its results yet. Employees of the company told the agency that the rush to test on animals leads to additional suffering and death of monkeys, pigs and sheep.
Neuralink's most successful brain chip competitor is Synchron, which has already received approval for human testing of a BCI implant designed to help paralyzed patients and has performed several surgeries.