Since 2019, Elon Musk has predicted that his medical device company, Neuralink, would soon start human trials of a revolutionary brain implant to treat intractable conditions such as paralysis and blindness.
In explaining the negative decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, a critical milestone on the path to final product approval, the staffers said.
The agency’s major safety concerns involved 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.
A year after the previously undisclosed rejection, Neuralink is still working through the agency’s concerns. Three staffers said they were skeptical the company could quickly resolve the issues – despite Musk's latest prediction at a Nov. 30 presentation that the company would secure FDA human-trial approval this spring.
The Neuralink sources declined to provide Reuters with the agency’s written rejection, a legally confidential document. The staffers, including four who had read the FDA document and others aware of the agency’s concerns, described the safety issues in interviews, speaking on condition of anonymity.
Such FDA rejections do not mean a company will ultimately fail to gain the agency’s human-testing approval. But the agency’s pushback signals substantial concerns, according to more than a dozen experts in FDA device-approval processes.
Musk and other Neuralink officials did not respond to requests for comment on the company’s device or its dealings with the FDA. The agency declined to comment on Neuralink, citing laws keeping commercial information private.