Neuralink, a brain implant startup owned by Elon Musk, declared that the FDA had approved their first in-human clinical trial. This milestone follows prior struggles for the company to acquire the approval. The company reported this in a tweet on May 25, 2023:
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
More information regarding the trial was withheld at this time, however Neuralink emphasized their close collaboration with the FDA and claimed this approval is an important first step toward using their technology to help many people.
According to Elon Musk, these brain implants may be potentially used to treat a number of ailments, such as diabetes, autism, depression, and schizophrenia, in addition to facilitating online web browsing directly from a person’s brain.
The FDA’s concerns about the device’s lithium battery, the possibility of the implant’s wires migrating inside the brain, and the safe removal of the device without harming brain tissue made it difficult for the business to obtain FDA approval in the past.
Neuralink, which was established in 2016, has been the focus of numerous federal investigations, including inquiries into pathogen trafficking by the Department of Transportation and procedures for using animals in research.