Musk’s Neuralink faces roadblock from FDA over animal lab mistake

According to the report, the FDA found several quality control issues in Neuralink’s laboratory for animal testing.

U.S. Food and Drug Administration investigators at Neuralink, a brain chip startup founded by Elon Musk, identified issues with record-keeping and quality control of animal testing. This happened less than a month after the company announced approval to test its brain implant in humans.

FDA Report Description

Neuralink’s device is about the size of a dime and is implanted in the skull, with ultra-thin wires threaded into the brain to create a brain-computer interface (BCI), according to an FDA report reviewed by Reuters.

A year after passing the test, Neuralink succeeded in implanting the first wireless brain chip into a human. Musk said the patient was recovering well. Moreover, these devices have a wide range of applications, from restoring motor function to activating brain-computer interfaces. However, there was no independent verification of Musk’s claims, and Neuralink did not present any position accordingly.

FDA inspectors discovered quality control lapses at the company’s California-based animal research facility during a visit. They visited from June 12 to June 22 last year. Tests conducted at Neuralink’s Texas facility found no problems.

These visits were the only FDA inspections of Neuralink facilities on record. The inspection report was shared with Reuters by Redica Systems. This is a data analytics company that receives FDA compliance reports through public records requests.

Laboratory issues identified by FDA investigators included missing calibration records for instruments such as a pH meter used in one of the studies, as well as seven instruments. This included a “vital signs monitor” whose records were not calibrated for other studies. Neuralink also tested hundreds of animals, including monkeys, in experiments.

Additionally, quality assurance personnel failed to approve the final study report or document any deviations from the approved protocol or standard operating procedures.

Chapman, the regulatory consultant, said this is definitely a sign that companies should be vigilant about certain practices. He also added that Neuralink should follow similar practices for human trials.

Brain implants are also being tested to help patients paralyzed by spinal cord injury or amyotrophic lateral sclerosis (ALS). It is possible to communicate by manipulating computer devices using one’s thoughts.

The story continues in 2022.

In 2022, Neuralink was investigated by the United States Department of Agriculture (USDA) for alleged animal welfare violations. They have been accused of conducting animal testing too quickly, causing unnecessary suffering and death. The Physicians Committee for Responsible Medicine has filed complaints with the USDA and FDA.

But last July, the USDA found no violations beyond the 2019 incident that Neuralink had already reported. The company announced that its device has been approved for human trials. Additionally, the FDA inspected human trial approvals to ensure data integrity, reliability, and compliance with other FDA regulations.

summary

Neuralink’s device is the size of a coin and is implanted in the skull using ultra-thin wires to develop a brain-computer interface. Issues identified by FDA inspectors included missing device calibration records. Additionally, the FDA inspected human trial approvals to ensure data integrity, reliability, and compliance with other FDA regulations.

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