After initially rejecting the brain-chip company's application, the US Food and Drugs Authority (FDA) has now given the green light for Neuralink to carry out in-human studies.
Funded by Elon Musk, Neuralink is a neurotechnology company that aims to create cranial computers to treat diseases and merge new advanced software abilities with the human brain. In addition to potentially treating brain diseases such as epilepsy and Parkinson's, the implanted device would also act as a sort of 'digital layer' that merges human grey matter with advanced technological tools.
The company revealed the news of its FDA approval on Twitter, the social media platform also owned by billionaire Elon Musk. In the same post, Neuralink also said it does not have immediate plans to start recruiting participants.
The news comes after Musk announced in December that he believed Neuralink would implant one of its devices in a human brain within the next six months. Musk previously said he was pushing for human trials to begin in 2020, a deadline he later changed to 2022, then again to 2023.
Neuralink has applied for FDA approval at least once before, but its application was rejected on safety grounds, according to a March report from Reuters that cited multiple current and former employees.
The company has now described the clearance as "an important first step" for its technology and "the result of incredible work by the Neuralink team in close collaboration with the FDA". The firm also promised more information would come "soon" in regard to its plans for human trials.
Neuralink has already been the subject of several federal investigations. In December 2022, it was revealed that the US Department of Agriculture's Inspector General was looking into possible animal welfare violations by the company after it was reported that about 1,500 animals - including more than 280 sheep, pigs and monkeys - have died as a result of Neuralink tests since 2018.
Elon Musk has also come under scrutiny for his $44bn acquisition of Twitter. The deal led to massive company layoffs immediately, changes in the social media's content moderation guidelines and even sparked fears of the platform being knocked offline.
The controversy has also affected the stock value of Tesla and SpaceX, the two other companies owned by the current world's richest man.
