US Regulators Rejected Neuralink's Bid To Test Brain Chips In Humans, Citing Safety Risks
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 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.
Neuralink has not disclosed details of its trial application, the FDA's rejection or the extent of the agency's concerns. As a private company, it is not required to disclose such regulatory interactions to investors. During the hours-long November presentation, Musk said the company had submitted "most of our paperwork" to the agency, without specifying any formal application, and Neuralink officials acknowledged the FDA had asked safety questions in what they characterized as an ongoing conversation. 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.
The rejection also raises the stakes and the difficulty of the company's subsequent requests for trial approval, the experts said. The FDA says it has approved about two-thirds of all human-trial applications for devices on the first attempt over the past three years. That total rose to 85% of all requests after a second review. But firms often give up after three attempts to resolve FDA concerns rather than invest more time and money in expensive research, several of the experts said. Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device.