Elon Musk’s Brain Implant Company Approved For Human Testing

By Hira Waheed

26 May 2023

Elon Musk's brain-implant company, Neuralink, has achieved a significant milestone after receiving approval from the US Food and Drug Administration (FDA) to commence its first-ever in-human clinical study. This development marks a crucial step forward for the company, which had previously faced challenges in obtaining regulatory clearance.
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Human Trials Delayed but Now Approved

Neuralink was required to address several concerns raised by the FDA before gaining approval for human trials. The FDA highlighted issues related to the device's lithium battery, the potential migration of implant wires within the brain, and the safe extraction of the device without causing harm to brain tissue, according to the employees.

Ongoing Investigations and Panel Oversight

As the FDA granted approval, US lawmakers are urging regulators to investigate the composition of the panel responsible for overseeing animal testing at Neuralink. This move comes amid concerns that the panel's structure may have contributed to rushed and problematic experiments.
Previous Investigations and USDA Oversight
Neuralink has been the subject of federal investigations, including an inquiry initiated by the USDA's inspector general in response to potential violations of the Animal Welfare Act. These investigations were prompted by concerns over the treatment and testing of certain animals, with Reuters reporting that over 1,500 animals, including sheep, pigs, and monkeys, were euthanized during experiments conducted by Neuralink since 2018. The USDA's oversight of Neuralink is also under scrutiny.

Neuralink's Future Plans

In a tweet, Neuralink clarified that it is not yet open for a clinical trial, despite receiving FDA approval. The company acknowledged the collaborative effort between its team and the FDA and expressed optimism about the technology's potential to assist many individuals in the future. Elon Musk has outlined an ambitious vision for Neuralink, envisioning a future where both disabled and healthy individuals can readily receive surgical implants at local centers. The aim is to address various conditions, from obesity, autism, depression, and schizophrenia, to enabling capabilities such as web browsing and telepathy.

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