The U.S. Food and Drug Administration will reject 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 grappling with. Stated. Reuters reportThis report is based on interviews with seven current and former Neuralink employees.
The revelation of the FDA’s rejection follows a flimsy public progress report from the company that has left Neuralink behind its competitors and Musk’s ambitious timeline. In 2016, he co-founded Neuralink, Musk said in 2019, the company aims to begin human trials by the end of 2020, with ambitious goals of treating spinal cord injuries and dementia. Said it was up. The November 2022 presentation showed little technical progress, but Musk said the company is still about six months away from human trials.
According to company documents last fall, Neuralink is on track to receive FDA testing approval by March 7 next week. But employees who spoke to Reuters said they weren’t confident they’d get it, with one calling it a “gambling.”
Last year’s FDA rejection reportedly listed dozens of “flaws” that Neuralink would need to address before the device could migrate to the human brain. Employees who read the FDA document and spoke with Reuters thought some of the concerns were relatively minor. But others were important. The FDA was particularly concerned about the safety of Neuralink’s proposed rechargeable lithium battery for its devices. Regulators said the company should conduct animal testing to show that the batteries are very unlikely to malfunction and damage brain tissue.
Another major concern reported by the FDA is that tiny wires in implants (thinner than a human hair) can migrate into the brain, causing inflammation, rupturing blood vessels and impairing brain function. bottom. The FDA was also concerned about the device overheating and wondered if it could be removed from people’s brains without causing damage.
Neuralink may be able to address and overcome all FDA concerns, but the company needs to do more animal testing. Current and former employees say Neuralink has treated them irresponsibly in the past. Specifically, some allege that the company abused research animals, including euthanizing more animals than it needed and performing “hack-job” surgeries to meet rushed deadlines for masks. The USDA 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 number of dangerous pathogens.
Neuralink did not immediately respond to Ars’ request for comment. Reuters also reported that Neuralink did not respond to a request for comment.