Elon Musk’s brain-implant company Neuralink on Thursday, May 25, said it had received a green light from the US Food and Drug Administration (FDA) to kickstart its first-in-human clinical study, a critical milestone after earlier struggles to gain approval.
The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and 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.
Victor Krauthamer, an adjunct biomedical engineering professor who spent three decades at the FDA, including a stint overseeing the office that reviews human-trial requests for brain implants, said the FDA does not typically inspect facilities as part of their review of applications for clinical trials. But he added this would have been warranted in this case, given the concerns around Neuralink’s animal experiments.
“If the animal testing is unreliable, then (human trial) approval may be based on flawed animal safety data. The FDA should have verified their trust of animal study results,” Krauthamer said.
Neuralink had hoped to receive approval to implant its device in 10 patients, Reuters has reported. But more recently, the company was negotiating a lower number of patients with the agency after it raised safety concerns, current and former employees said. It is not known how many patients the FDA ultimately approved.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling Web browsing and telepathy. He made headlines late last year when he said he was so confident in the devices’ safety that he would be willing to implant them in his children.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company sought FDA approval only in early 2022, and the agency rejected the application, Reuters reported in March.
The FDA had pointed out several safety concerns to Neuralink that needed to be addressed before sanctioning human trials, Reuters 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. – Rappler.com
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