U.S. regulators have rejected Elon Musk’s Neuralink from testing its brain implant technology in humans, according to seven current and former employees. The Food and Drug Administration (FDA) identified dozens of safety concerns that must be resolved before human trials can proceed.
Key Safety Issues Identified
The FDA’s rejection, which occurred but hasn’t been previously reported, highlighted three major concerns: the device’s lithium battery, potential migration of microscopic wires within the brain, and challenges surrounding safe removal without damaging brain tissue. The agency also raised questions about possible overheating of the device.
Regulatory Challenges for Ambitious Timeline
Despite Musk’s repeated predictions of imminent human trials, Neuralink didn’t submit its application until 2022. The rejection comes as the company faces federal investigations into its animal research practices and transportation of biological materials. Current employees express skepticism about meeting Musk’s latest prediction of FDA approval this spring.
Industry Context and Competitive Landscape
Neuralink operates in the emerging brain-computer interface (BCI) field, competing with more than a dozen companies in the $6 billion neuromodulation device market. While the FDA has approved similar devices for conditions like Parkinson’s disease, no company has received final approval for a BCI implant.
Cultural Clash With Regulatory Process
More than a dozen current and former employees describe a company culture that prioritizes rapid innovation over regulatory compliance. Neuralink has declined assistance from the National Institutes of Health, with Musk reportedly viewing government involvement as bureaucratic. The company secured FDA “breakthrough” designation but still faces significant hurdles.
Leadership and Organizational Challenges
Neuralink has experienced significant turnover among its leadership, with nearly all original founders departing. Musk remains actively involved but divides his attention among multiple companies. The company relies heavily on young employees, with some key regulatory roles filled by staff in their 20s lacking medical device experience.
Path Forward Uncertain
Regulatory experts note that FDA rejections are common in device development, with about two-thirds of applications approved on first attempt. However, Neuralink’s ambitious approach and Musk’s public statements create additional pressure on regulators. The company may pursue a staged trial approach to address remaining concerns.
“The reason we don’t have a device like Neuralink’s yet isn’t because no one has spent money on it,” said former FDA and NIH neurophysiologist Gene Civillico. “It’s because it’s a hard problem.”
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