The Food and Drug Administration rejected the application of an Elon Musk-funded startup that intended to install computer interfaces into the human brain.
Neuralink had its application for starting human testing rejected by the FDA in 2022, according to Reuters. The agency said Neuralink had to address dozens of issues before human testing would be allowed. These included safety concerns about the device's battery, the potential for device wires to migrate to other parts of the brain, and whether the device can be removed without damaging the brain.
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The revelation of the FDA rejection contrasts with prior predictions from Musk, who claimed on Nov. 30 that the company would receive FDA human trial approval by the end of spring 2023.
Neuralink has not released details about its trial application, the rejection, or specifics on the agency's concerns.
The rejection may have come about in part due to Musk's differing views on regulators, according to former staffers. The billionaire has been regularly critical of agencies such as the FDA and the Securities and Exchange Commission and has regularly attempted to evade their rules. He also ran the startup similarly to his other businesses, which may not have allowed the company to accommodate all relevant medical concerns.
The Department of Agriculture's Inspector General opened an investigation into Neuralink's experiments in early 2022 over allegations that the company had violated animal welfare laws.
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Over 20 current and former employees alleged that pressure from Musk to speed up development led to more failed experiments and animals being tested and killed. More than 1,500 animals are estimated to have been killed by the company following experiments since 2018, including 280 sheep, pigs, and monkeys.
The company was also sued by activists in Feb. 2022, who alleged that Musk's organization had tortured and mutilated monkeys while researching the subject.