The FDA cited “dozens” of safety issues that need to be resolved by Elon Musk’s Neuralink before going ahead with its tests.
The US Food and Drug Administration ( FDA ) has rejected Neuralink ‘s request to begin human trials of its developing brain chips .
Despite repeated assertions by its chief executive, Elon Musk, the prospects of brain-computer interface (BCI) startup Neuralink bringing a product to market remain dim, according to a new Reuters report.
According to the report, the FDA denied the company authorization in 2022 to conduct human trials.
“The agency’s primary safety concerns involved the device’s lithium battery, the possibility of the tiny implant wires migrating to other areas of the brain, and questions about whether and how the device can be removed without damaging the brain tissue,” current and former Neuralink employees told the outlet.
FDA ‘s concerns regarding the battery system and its novel transdermal charging capabilities revolve around the potential for device failure.
The FDA is also very concerned about potential problems should the device have to be removed entirely, either for replacement or upgrade, due to the tiny size of the electrical wires that extend into the patient’s gray matter. Those wires are so small and delicate that they risk breaking during removal (or even regular use) and then migrating to other parts of the brain where they could lodge in something important.
During the Neuralink open house last November, Musk confidently stated that the company would get FDA approval “ within six months.”
Elon Musk is trying to speed up progress at Neuralink , a company that wants to implant its first brain chips in humans in the coming months.
On several occasions over the years, Musk has told employees to imagine they have a bomb strapped to their heads in an effort to get them to move faster, according to three sources who repeatedly heard the comment. Musk once told employees a few years ago that he would cause “market failure” at Neuralink unless they made more progress, a comment some employees perceived as a threat to shut down operations.
According to sources, Neuralink releases tests in rapid succession before fixing issues in previous tests or drawing full conclusions. The result: More animals are generally tested and killed, in part because the approach leads to repeated testing.
Musk’s insistence is also due to the fact that other companies are already in higher stages than his company. Synchron, for example, has already received FDA approval for human implants since last year . Furthermore, only 80 sheep have died during their investigation since 2016.