U.S. FDA says Musk's Neuralink has problems with animal testing

According to Reuters, the U.S. Food and Drug Administration (FDA) approved Neuralink for human testing of a brain-computer interface less than a month ago, but later discovered that the company had some problems with animal experiment record keeping and quality control. .

Neuralink had gaps in quality controls at its California animal research facility, while inspections of facilities in Texas found no similar problems, investigators have found.

Jerry L. Chapman, senior quality specialist at Redica Systems, said: "These issues demonstrate a lack of attention to detail on the part of (Neuralink)."

Lab issues found by FDA inspectors included a lack of calibration records for some instruments, such as a pH meter used in a study. Additionally, in another study, seven instruments, including a "vital signs monitor," also had no calibration records. Neuralink conducted hundreds of experiments, including on monkeys.

Other issues include the quality assurance officer not signing off on the final study report and not documenting any deviations from the approved protocol or standard operating procedures.

Currently, Neuralink is undergoing real-person testing and is designed to help patients who have been paralyzed by spinal cord injury or amyotrophic lateral sclerosis regain the ability to communicate. More information about this study can be found in previous coverage on this site.

According to a December 2022 Reuters report, investigators from the U.S. Department of Agriculture (USDA) are investigating Neuralink for alleged animal welfare violations. Earlier, internal employees complained that the company was too hasty in conducting animal testing, causing animals to suffer unnecessary suffering and even death. The Council for Responsible Medicine, an organization responsible for animal welfare, has filed formal complaints with the U.S. Department of Agriculture and the Food and Drug Administration, accusing Neuralink of violating regulations.

Related reading:
"Musk said Neuralink's first human patient has been able to brain-control a mouse, but its safety has been questioned"

"Nearly a year later, Musk's brain-computer It was revealed that the interface company was fined for violating regulations. What happened? 》

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