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

April 19, 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 the dozen of issues Elon Musk’s company Neuralink must first address before being able to begin human testing of their brain-computer interface (BCI) device. According to Neuralink sources, the agency’s major safety concerns involved the device’s lithium battery, whether the device could overheat or be removed without damaging brain tissue, and the possibility that the device’s tiny threads, which carry electrodes, could migrate to other areas of the brain. 

Regarding the latter issue, Visiting Professor of Biomedical Engineering at GW and former FDA official for three decades Victor Krauthamer said, “Migrating wires can induce inflammation, impair function in critical areas of the brain and rupture blood vessels. A migration problem can also erode the device’s effectiveness, he and other experts said.” 

“The threads can cause damage because brains are very, very soft and very delicate,” Krauthamer said.

In the IEEE Spectrum article titled, “Neuralink’s FDA Troubles Are Just Beginning,” Krauthamer also commented. This article references 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 including neural implants collected from diseased animal subjects. 

“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.

Another potential issue is the wide range of claims Musk and other company representatives have made regarding their BCI device. “While Neuralink’s current application will be limited to a single indication, like thought-to-type, Krauthamer believes that the larger claims made around the device may draw increased scrutiny from FDA regulators: “It may raise more questions for them because of these broad, unsubstantiated claims. Officially, the FDA just reviews the evidence in front of them, but there’s a context to that, and I think that context may bring out additional caution.” Dr. Krauthamer’s course at GW on Medical Device Engineering Evaluation explores the FDA criteria for medical device approvals, including Neuralink.

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.