Neuralink, the brain-implant startup founded by Elon Musk, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting clearance for its first human clinical trial. This approval is crucial for Neuralink as it navigates ongoing investigations into its handling of animal experiments.
In a tweet, Neuralink expressed that the FDA clearance is a significant first step towards leveraging their technology to benefit numerous individuals. Although specific details of the planned study were not disclosed, Neuralink clarified that they are not currently recruiting for the trial but will provide more information soon.
While the FDA confirmed that it granted Neuralink permission to conduct trials on patients using its brain implant and surgical robot, further details were not provided by the agency.
Neuralink has faced scrutiny following reports on the company’s animal experiments. Last year, Neuralink employees revealed to Reuters that the company was rushing and mishandling surgeries on animals, resulting in unnecessary animal deaths. The pressure from Musk to obtain FDA approval allegedly contributed to these incidents. The data from these experiments was intended to support Neuralink’s application for human trials.
Instances of improper implant sizing, leading to the death of pigs, raised concerns about the lack of preparation. Lawmakers in the U.S. called for investigations into potential financial conflicts within the panel overseeing animal testing at Neuralink.
Additionally, the Department of Transportation is investigating whether Neuralink unlawfully transported dangerous pathogens without proper containment measures. The U.S. Department of Agriculture’s Office of Inspector General is conducting its own probe into potential animal-welfare violations and the USDA’s oversight of Neuralink.
Neuralink’s laboratory practices had not been inspected by the FDA as of a few weeks ago, despite concerns about the reliability of the company’s animal testing. While facility inspections are not typically part of the FDA’s review process for clinical trial applications, experts suggest that it would have been warranted in this case due to the concerns surrounding Neuralink’s animal experiments.