The brain implant company of Elon Musk Neuralink, announced today (Friday) that it has received the green light from the US Food and Drug Administration (FDA) to begin its first clinical study of implanting chips in human brains.
The company tweeted that “this is the result of amazing work by the Neuralink team in close cooperation with the FDA, and it is an important first step that will allow our technology to one day help many people.”
The FDA pointed out to Musk’s company several things that must be taken care of before the human trials, among them: treatment of problems with the chip battery, correcting the possibility of the implant wires migrating inside the brain and the challenge of safely extracting the chip without damaging the brain tissue.
The company, founded in 2016, only applied for FDA approval early last year and the FDA previously rejected their request. The approval now comes after US lawmakers are calling on regulators to investigate whether the composition of the panel overseeing Neuralink’s animal experiments, and whether flawed and rushed experiments were done.
Last year, the USDA’s inspector general began investigating, at the request of a federal prosecutor, potential violations of the Animal Welfare Act, which regulates how researchers handle and test certain types of animals. It turns out that the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018.