The US regulator has refused to grant Elon Musk's company Neuralink permission to test brain implants on humans.
Source. Reuters writes about this in an investigation on the work of Neuralink.
Several former and current employees told the agency that in early 2022, the company submitted an application to the Food and Drug Administration (FDA), but it was rejected.
Musk has announced that Neuralink plans to test brain chips on humans several times since 2019. According to the entrepreneur, the implants developed by the company can potentially help treat diseases such as paralysis and blindness.
As a short-term goal, Neuralink representatives mentioned the creation of a mechanism that would allow paralyzed patients to communicate using computer text without typing it.
The FDA, however, recognized that the risks are too great now. In justifying the refusal, the regulator listed dozens of problems that Neuralink must solve before proceeding to human trials.
According to Reuters sources, the biggest concerns were the device's lithium battery; the possibility that the implant's tiny wires could migrate to other parts of the brain; and the question of how to remove the device without damaging brain tissue, and whether it is possible at all. The agency's interlocutors said that a year after the FDA's refusal, the company still has not solved the problems.
Nevertheless, Musk promised in November that Neuralink would receive regulatory approval in the spring of 2023.
Neuralink was founded in 2016 and has an estimated value of over $1 billion. In April 2021, the company showed a monkey that had a chip implanted in the motor cortex of both cerebral hemispheres. The animal could control the cursor on a computer monitor with its mind and thus play ping-pong: the cursor moved depending on the patterns of neural activity that occur in the motor cortex.
Background. In 2022, Reuters reported that the US government had launched an investigation into Neuralink's animal testing practices.
As a reminder, Bill Gates and Jeff Bezos invested $75 million in Neuralink's competitor.