Elon Musk’s Neuralink company has received clearance for its first human clinical trial of brain implants, as it faces US probes over its handling of animal experiments.
The approval from the US Food and Drug Administration “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet.
It added it is not recruiting for the trial yet and said more details would be available soon.
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.
In one instance in 2021, the company implanted 25 out of 60 pigs with the wrong-sized devices. All the pigs were subsequently killed – an error that employees said could have been easily avoided with more preparation.
Animal abuse probe
The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Neuralink is also under investigation by the US Department of Agriculture’s Office of Inspector General for potential animal-welfare violations. This probe has been looking at the USDA’s oversight of Neuralink.
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 safety concerns were raised, 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. 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.
-AAP
