After there were mainly negative reports about Neuralink, the company is now celebrating a success: the FDA has now allowed it to carry out tests on humans.
Machine for planting the implant (Image: Neuralink)
US billionaire Elon Musk’s medical technology company Neuralink says it has received FDA approval for human trials. The company announced on Twitter that the first clinical study could now begin. Neuralink develops Brain-Computer Interfaces (BCI) to connect a human brain to a computer. This is intended to provide relief in the event of serious illnesses. After Musk repeatedly announced that such tests should begin “soon”, it became known in the spring that the FDA had identified several obstacles.
Recruitment of test subjects has not yet started, Neuralink added to the announcement. More information will be released “soon”. The company’s blog is currently unavailable due to maintenance work. The announcement suggests that the FDA’s concerns were allayed faster than expected. According to Neuralink, the approval is the result of “incredible work” by its own team and the closely cooperating FDA. It is an important first step that will one day allow our own technology to help many people.
Many doubts at the FDA
It wasn’t until early March that it became public that the FDA had seen dozens of issues that needed to be addressed before such human trials could begin. According to insiders, the most critical aspects were the implant’s lithium battery and the risk of parts of the device once implanted migrating to other regions of the brain. It was also not sufficiently answered whether and how the device can be removed without brain damage remaining. Neuralink has now apparently eliminated all these worries. It also became known at the time that Neuralink had only applied for the tests in 2022, although Musk had announced in 2019 that they would take place “soon”.
In December, it became known that the Inspector General of the US Department of Agriculture was investigating Neuralink. It was about the suspicion that possibly too many animals were killed for the BCI development. Since the experiments began, Neuralink has killed 1,500 test animals, including over 280 sheep, pigs, and monkeys, it said at the time. This could also have consequences for the supervisory authority itself. US law enforcement officers have been investigating the role of the US Department of Agriculture oversight for months. The authority is also said to have failed to take sufficient action against violations at other research institutions.
TechAint 