Posted on 05/28/23
| News Source: Reuters
Elon Musk's Neuralink received U.S. Food and Drug Administration (FDA) clearance for its first-in-human clinical trial, a critical milestone for the brain-implant startup as it faces U.S. probes over its handling of animal experiments.
The FDA approval "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet on Thursday, without disclosing details of the planned study. It added it is not recruiting for the trial yet and said more details would be available soon.
The FDA acknowledged in a statement that the agency cleared Neuralink to use its brain implant and surgical robot for trials on patients but declined to provide more details.
Neuralink and Musk did not respond to Reuters requests for comment.
The critical milestone comes as Neuralink faces federal scrutiny following Reuters reports about the company's animal experiments.
Neuralink employees told Reuters last year that the company was rushing and botching surgeries on monkeys, pigs and sheep, resulting in more animal deaths than necessary, as Musk pressured staff to receive FDA approval. The animal experiments produced data intended to support the company's application for human trials, the sources said.