Dr. Krauthamer on FDA Safety Concerns Surrounding Neuralink's Request to Begin Human Trials

April 3, 2023

Dr. Victor Krauthamer

In the article, “U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks,” Reuters outlines a dozen issues Elon Musk’s company Neuralink must first address before the FDA approves them to begin human testing of their brain-computer interface (BCI) device. Dr. Victor Krauthamer, a visiting biomedical engineering professor at GW, commented on these issues in the article, particularly focusing on the possibility that the device’s tiny threads could migrate to other areas of the brain. 

Here is an excerpt from the article:  “The threads can cause damage because brains are very, very soft and very delicate,” Krauthamer said.

In a similar article titled, “Neuralink’s FDA Troubles Are Just Beginning,” IEEE Spectrum referenced the investigations of two other U.S. government agencies, the Department of Agriculture and the Department of Transportation, into Neuralink’s alleged animal abuse and mismanagement and interstate portage of biohazardous materials. Due to his extensive experience working at the FDA, Krauthamer was interviewed again on this matter.

Here is an excerpt from the article: “If the experiments are tainted in some way, then the FDA may require new data. If the animal studies are questionable, they will have to be redone,” Krauthamer says.

Read the full article on Reuters to learn more about why Neuralink is facing this initial rejection and dive deeper into Neuralink’s future struggles with FDA approval on IEEE Spectrum.