By Rachael Levy and Hyunjoo Jin
Last month, Neuralink said it received U.S. Food and Drug Administration clearance for its first-in-human clinical trial, a critical milestone for the startup as it faces U.S. probes over its handling of animal experiments. The FDA acknowledged in an earlier statement to Reuters that the agency cleared Neuralink to use its brain implant and surgical robot for trials but declined to provide more details.
The company, founded in 2016, first sought permission from the FDA in early 2022, and the agency rejected the application, citing dozens of safety concerns, Reuters has reported. Some of the issues involved the lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.Neuralink also faces federal scrutiny following Reuters reports about its animal experiments.
In May, U.S. lawmakers urged regulators to investigate whether the makeup of Neuralink's panel overseeing animal testing contributed to botched and rushed experiments after Reuters reported on potential financial conflicts on the board.