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Exclusive: US legislator requests answers on FDA investigation of Musk's Neuralink

Neuralink logo and Elon Musk silhouette are featured in this image shot, December 19, 2022.

WASHINGTON, March 26 (mod1s) - A U.S. politician interested in health policy has questioned the Food and Drug Administration why it did not investigate Elon Musk's Neuralink before permitting the brain implant business to test its technology in people.

Reuters revealed this month that FDA inspectors identified flaws with record keeping and quality controls for animal trials at Neuralink in June, less than a month after the firm declared it was approved to test its brain implants in people.

Neuralink, which originally tested the gadget in monkeys and other animals, is now testing the device in people. The firm creates a brain-chip which allows disabled individuals to manage a computer using just their thoughts.

In a letter to the FDA on Monday, Democratic U.S. Representative Earl Blumenauer said he was worried the agency overlooked "troubling evidence" of animal testing infractions that had been raised going back to at least 2019.

Blumenauer also noted stories by Reuters from late 2022 that revealed staff' accusations of "hack jobs" of animal studies owing to a tight deadline, inflicting unnecessary suffering and fatalities. Employees were concerned that data quality might be compromised, the media group stated at the time. He requested the FDA to explain how it harmonized allegations of such breaches with its decision to permit Neuralink's human study.

"These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials," said Blumenauer, who serves on the House Ways and Means subcommittee on health.

In response to questioning from Reuters about the letter, the FDA said it will react to the legislator personally. The FDA also claimed it frequently conducts out checks once a human experiment is authorized. When it examined Neuralink, the FDA claimed it did not identify infractions that would jeopardize the safety of the experiment.

Neuralink did not immediately react to inquiries.

In recent years, a number of device firms have started testing such brain implants in people, notably Synchron and Blackrock Neurotech, who have both proved the capacity of patients to control specific behaviors with their thoughts.

Last week, Neuralink presented a livestream on Musk's social media platform X, showcasing how the first patient implanted with its brain gadget was able to play online chess using his thoughts. Noland Arbaugh, a 29-year-old who was paralyzed below the shoulders following a diving accident, also wrote a remark on X by conveying his feelings.


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