Elon Musk‘s Nueralink will not be testing its brain implant on humans anytime soon – the US Food and Drug Administration (FDA) has rejected the company’s application.
The agency outlined dozens of issues the company must address before human testing, a critical milestone for final product approval, Neuralink staffers told Reuters.
The concerns include the device’s lithium battery; the potential for the implant´s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said.
Musk applied in early 2022, but staffers said the company co-founder has yet to solve all the problems – even though the billionaire revealed human trials would start in six months back in November.
Three staffers said they were skeptical the company could quickly resolve the issues.
During the hours-long November 30 presentation, Musk said the company had submitted ‘most of our paperwork’ to the FDA, without specifying any formal application.
But he appeared to be sure about the six-month timeline.
Neuralink officials acknowledged the FDA had asked safety questions in what they characterized as an ongoing conversation.
The sources declined to provide Reuters with the agency´s written rejection, a legally confidential document – but described them in an interview.
The company has been under scrutiny for the past few months as animal advocacy groups and former employees are sounding the alarm over animal welfare violations.
Lab notes by staffers who conducted experiments at the University of California Davis (UC Davis) show animal issues with the implants, echoing the FDA’s concerns.
The FDA’s rejection listed dozens of what the agency calls ‘deficiencies’ that the company must address before human trials, five Neuralink sources said.
The implant features tiny threads that carry electrodes and are fixed into the head, but the FDA is concerned threads could migrate to other brain areas, according to six current and former employees.
