Neuralink, the brain-implant company founded by Elon Musk, announced on Thursday that it had received approval from the US Food and Drug Administration (FDA) to commence its first clinical study involving human participants. This is a significant milestone for the company, which had previously faced challenges in obtaining approval. Since 2019, Musk has made multiple predictions about initiating human trials for a brain implant designed to treat severe conditions like paralysis and blindness. However, Neuralink, established in 2016, only pursued FDA approval in early 2022, resulting in the rejection of their application, according to seven current and former employees who spoke to Reuters in March.
The FDA had raised several concerns that needed to be addressed by Neuralink before granting approval for human trials. These concerns included issues with the device’s lithium battery, the potential migration of the implant’s wires within the brain, and the safe extraction of the device without causing damage to brain tissue.
The FDA’s recent approval comes at a time when US lawmakers are urging regulators to investigate whether the composition of a panel overseeing animal testing at Neuralink contributed to failed and rushed experiments. Neuralink has already been under investigation by federal authorities.
Last year, the Office of Inspector General of the United States Department of Agriculture (USDA) initiated an investigation, prompted by a federal prosecutor’s request, into potential violations of the Animal Welfare Act. This act governs the treatment and testing of specific animal types by researchers. Reuters previously reported that Neuralink has conducted experiments resulting in the deaths of approximately 1,500 animals, including over 280 sheep, pigs, and monkeys since 2018. The investigation is also examining the USDA’s oversight of Neuralink.
In a tweet on Thursday, Neuralink clarified that it is not currently accepting participants for a clinical trial. The company expressed gratitude for the collaboration with the FDA, emphasising that this approval is a crucial initial step towards enabling their technology to assist numerous individuals in the future.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
— Neuralink (@neuralink) May 25, 2023
Musk has consistently outlined an ambitious vision for Neuralink. Late last year, he garnered attention by stating his confidence in the device’s safety, going so far as to express willingness to implant it in his own children. Musk envisions a future where both disabled and healthy individuals can easily receive surgical implants at local centres, aiming to address a wide range of conditions from obesity, autism, depression, and schizophrenia to providing capabilities like web browsing and telepathy.