At least four times since 2019 Elon Musk predicted that Neuralink would soon begin clinical trials of a revolutionary chip that implanted in the brainwith the aim of rehabilitating incurable cases such as paralysis and blindness.

Neuralink, based in San Francisco, California, and Austin, Texas, is developing brain chips with medical applications, such as making it easier for paralyzed people to walk and communicate again. So far, it has only been tested on animals, but a few months ago it applied for permission from the U.S. Food and Drug Administration (FDA) to test its technology on humans.

However, the FDA denied the application, seven former and current employees of the company told Reuters.

This development was not known until today, although the Neurolink company, founded in 2016, applied for a license from the beginning of 2022.

In explaining its decision, the workers said, the FDA cited dozens of questions a company must first resolve in order to gain approval for human clinical trials, a milestone on the road to final product approval.

Among the safety issues raised by the US Food and Drug Administration were the device’s lithium battery, the risk of transferring tiny implant wires to other areas of the brain, and the possibility and method of removing the device without damaging brain tissue.

Neurolink did not disclose details about its use for human clinical trials, the FDA’s negative response, or the extent of concern from the US agency. As a private company, it is not required to disclose such regulatory processes to investors.

During a presentation last November, Elon Musk said the company had submitted “most of the required documents” to the service, without citing an official statement, and Neuralink officials acknowledged that the FDA had raised questions about the product’s safety.

However, as noted by Reuters, such refusals do not necessarily mean that the company was unable to obtain approval for its human clinical trials.

It is noted that the main ambition of the company is the development of an electronic implant in the brain, which, with appropriate adjustments, every time will allow to make various medical “revolutions”such as restoring sight to the blind, restoring mobility to the paralyzed, and treating people suffering from dementia, Alzheimer’s and Parkinson’s. At some point, it also provides for the “marriage” of the human brain with artificial intelligence.

At the moment, however, Neuralink is making slow progress, and competitor Synchron, which has already been invested in by the likes of Jeff Bezos and Bill Gates to develop microchip implant technology in the human brain, already made its first major “jump” last July. . when he first implanted the chip on a patient in the US and also tested it on four people in Australia.

Source: Reuters.