US regulator blocks Neuralink from testing brain chip on humans

The US Food and Drug Administration (FDA) didn’t allow Neuralink, founded by businessman Elon Musk, to conduct tests on people that involve implanting a microchip into the brain to control external devices with the power of thought, Report informs referring to Reuters.

The rejection has not been previously reported. In explaining the 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 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 November 30 presentation that the company would secure FDA human-trial approval this spring.