Dr. Krauthamer Questions FDA Decision to Approve Human Trials for Neuralink

June 7, 2023

Dr. Victor Krauthamer

In the article, “Elon Musk’s Neuralink wins FDA approval for human study of brain implants,” Reuters examined the FDA’s decision to clear Neuralink for its first-in-human clinical trials. The FDA did not provide more details beyond its statement acknowledging that they cleared Neuralink to use its brain implant on patients, which has raised skepticism as Neuralink currently faces ongoing investigations surrounding its handling of animal experiments by both the Department of Transportation and the U.S. Department of Agriculture’s Office of Inspector General.

Dr. Victor Krauthamer, visiting biomedical engineering professor at GW who spent three years at the FDA, including a stint overseeing the office that reviews human-trial requests for brain implants, told Reuters that the FDA does not typically inspect facilities as part of their review of applications for clinical trials. But he added this would have been warranted in this case, given the concerns around Neuralink’s animal experiments.

“If the animal testing is unreliable, then (human trial) approval may be based on flawed animal safety data. The FDA should have verified their trust of animal study results,” Krauthamer said.

Read the full article on Reuters. For another article on this topic featuring Dr. Krauthamer, visit the Guardian.