The Food and Drug Administration denied a human-trials application from Elon Musk’s brain-computer interface company, Neuralink, in early 2022, citing dozens of concerns about the company’s device that employees are still working to address, according to a report by Reuters. The report is based on interviews with seven current and former Neuralink employees.
The revelation of the FDA rejection tracks with the thin public progress reports from the company, which place Neuralink behind rivals as well as Musk’s ambitious timelines. Musk, who co-founded Neuralink in 2016, said in 2019 that the company aimed to start human trials by the end of 2020 and held lofty goals of curing spinal cord injuries and dementia. In a November 2022 presentation, which showed little technological progress, Musk said the company was still about six months away from human trials.
According to a company document from last fall, Neuralink expected to get FDA authorization for trials by March 7—next week. But employees who spoke with Reuters said they are not confident they’ll get it, with one calling it a “gamble.”