USDA

Neuralink

Story

FDA has found some issues with the quality controls with the animal experiments Neuralink’s&nbsp; labs, according to their report&nbsp;
Issues related to record-keeping and quality controls for animal experiments were identified by the inspectors of the US Food and Drug Administration (FDA) at Neuralink, the brain-chip startup founded by Elon Musk. It happened less than a month after the company announced its clearance to test its brain implants in humans.&nbsp;
<h2 class="wp-block-heading" id="strong-the-fda-report-explained-strong">The FDA Report Explained</h2>
The FDA report, which Reuters reviewed, revealed that Neuralink’s device is the size of a coin and is implanted in the skull, with ultra-thin wires that go into the brain and develop a brain-computer interface (BCI).&nbsp;
A year after being cleared for the test, Neuralink has successfully implanted its wireless brain chip in a human for the first time. Musk revealed that the patient is recovering well. Besides, the device has multiple applications, from restoring motor functionality to enabling a brain-computer interface. However, there was no independent verification of Musk’s claims, and Neuralink did not offer any statements in addition to this.
The FDA inspectors found quality control lapses at the company’s California-based animal research facility during their visits. They visited between June 12 and June 22 last year. No issues were found during an inspection conducted at the Neuralink’s Texas facility.
These visits were the only FDA inspections of Neuralink facilities on record. The inspection reports were shared with Reuters by Redica Systems. That’s a data analytics company, obtaining FDA compliance reports via open records requests.&nbsp;
The laboratory problems identified by FDA inspectors include missing calibration records for instruments like a pH meter used in one of the studies, and seven instruments. This included a “vital signs monitor,” which had no record of being calibrated for another study. Moreover, Neuralink tested hundreds of animals, including monkeys, in their experiments.&nbsp;
Additionally, quality assurance officials failed to sign off on the final study report or document any deviations from approved protocols or standard operating procedures.
Chapman, a regulatory consultant said that this certainly is a signal that the company needs to be vigilant about certain practices. He also added that Neuralink would be required to follow similar practices for its human trials.&nbsp;
Moreover, tests are being conducted on a brain implant that aims to assist patients who are paralyzed due to spinal cord injury or amyotrophic lateral sclerosis (ALS). It is being done to communicate by using their thoughts to operate a computer device.
<h2 class="wp-block-heading" id="strong-the-story-links-to-2022-strong">The Story Links to 2022</h2>
In 2022,<a href="https://www.thecoinrepublic.com/2023/05/26/elon-musk-congratulates-his-neuralink-team-for-fdas-approval/" target="_blank" rel="noopener noreferrer nofollow"> Neuralink </a>was investigated by the US Department of Agriculture (USDA) for animal welfare violations. They were accused of conducting animal testing too quickly, causing unnecessary suffering and death. The Physicians Committee for Responsible Medicine submitted a complaint to the USDA and the FDA.&nbsp;
However, in July, the USDA found no violations beyond a 2019 incident that Neuralink had already reported. The company announced that its device was cleared for human trials. Moreover, The FDA inspected human trial approval to ensure data integrity, reliability, and compliance with other FDA regulations.
<h3 class="wp-block-heading" id="strong-summary-strong">Summary</h3>
Neuralink’s device is the size of a coin and is implanted in the skull, with ultra-thin wires that develop a brain-computer interface. The problems identified by FDA inspectors included missing calibration records for instruments. Moreover, The FDA inspected human trial approval to ensure data integrity, reliability, and compliance with other FDA regulations.
<h5 class="wp-block-heading">Disclaimer</h5>
The views and opinions stated by the author, or any people named in this article, are for informational purposes only. They do not establish financial, investment, or other advice. Investing in or trading in stocks, cryptos or any other related indexes comes with a risk of financial loss.

Musk’s Neuralink Suffers Hurdles from FDA for Animal Lab Lapses

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