The Food and Drug Administration has denied a human trial 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 Reuters report. The report is based on interviews with seven current and former Neuralink employees.
The revelation of the FDA rejection follows thin public progress reports from the company, which put Neuralink behind competitors as well as Musk’s ambitious timelines. Musk, who founded Neuralink in 2016, said in 2019 that the company aimed to begin human trials by the end of 2020 and had lofty goals for treating spinal cord injuries and dementia. In a November 2022 presentation that 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 was expected to receive FDA authorization for testing by March 7—next week. But employees who spoke to Reuters said they weren’t sure they would get it, with one calling it a “gamble.”
The FDA’s rejection last year reportedly listed dozens of “deficiencies” that Neuralink must address before its device can be transplanted into the human brain. Some concerns were dismissed as relatively minor by officials who read the FDA document and spoke to Reuters. But others were important. The FDA was particularly concerned about the safety of the rechargeable lithium batteries that Neuralink proposed for its device. The regulator said the company needed to do animal tests to show the battery was highly unlikely to malfunction, which could damage brain tissue.
Another reportedly serious concern from the FDA was that the implant’s tiny wires—which are thinner than individual human hairs—could migrate into the brain, possibly causing inflammation, ruptured blood vessels and impairments in brain function. The FDA was also concerned about the device overheating and questioned whether it could be removed from people’s brains without causing harm.
While Neuralink may be able to address and overcome all of the FDA’s concerns, the company will need to do more animal testing — which current and former employees say Neuralink has handled irresponsibly in the past. Specifically, some alleged that the company abused research animals, including euthanizing more animals than necessary and performing “hack job” surgeries to meet Musk’s rushed deadlines. The Department of Agriculture has launched an investigation into Neuralink for possible animal welfare violations. Similarly, the Department of Transportation is investigating whether Neuralink violated federal transportation regulations when it allegedly shipped brain implants removed from research monkeys infected with a range of dangerous pathogens.
Neuralink did not immediately respond to requests for comment from Ars. Reuters also reported that Neuralink did not respond to requests for comment.