Elon Musk’s Neuralink has been working on a brain-computer interface (BCI) technology that allows people to interact with computers by thinking. The goal is to help people with paralysis or other mobility impairments. However, according to a recent report, the US Food and Drug Administration (FDA) rejects Neuralink’s application until it resolves dozens of issues with its implantable device.
Musk has been claiming on Twitter that the Neuralink brain chip is on the verge of being tested in humans, with FDA approval expected this spring. However, the FDA’s rejection, which Neuralink hasn’t made public, cites many issues ranging from simple to serious.
The agency is asking Neuralink to ensure that the more than 1,000 ultrafine electrodes inserted into the brains of Neuralink’s first subjects don’t move over time. Moreover, Neuralink has yet to demonstrate that the implant can be removed without causing brain damage. The FDA is also concerned about batteries used by the company during the monkey test and proprietary wireless charging system. Neuralink has to demonstrate that lithium-ion batteries have a very low failure rate; otherwise, any malfunction could overheat and damage brain tissue.
Reuters said conversations with over a dozen current and former Neuralink employees revealed a culture of antipathy toward regulators. Under Musk’s leadership, Neuralink has set an aggressive schedule and sees regulators as an obstacle to achieving its goals, according to the employees.
Furthermore, employees say Musk insisted on keeping his distance from the National Institutes of Health (NIH) for fear of public scrutiny, despite NIH’s offer to help. This led to the government launching an investigation into Neuralink’s treatment of experimental animals.