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FDA Approves Neuralink Human Study for Brain Implants: A Milestone for Elon Musk’s Company

Elon Musk’s brain implant business, Neuralink, declared on Thursday that it has been given FDA approval to start its first clinical study on humans.

In multiple instances since 2019, Elon Musk has made predictions that his medical device company would commence human trials for a brain implant designed to treat severe ailments like paralysis and blindness. 

Lawmakers Demand Probe into Neuralink Animal Testing

Nevertheless, according to ex-employees who disclosed information in March, despite its establishment in 2016, the company did not commence the FDA approval process until early 2022, resulting in the subsequent rejection of their application.

The employees revealed that the FDA had raised various concerns that Neuralink needed to address before granting permission for human trials. These concerns primarily revolved around the lithium battery of the device, the potential migration of the implant’s wires within the brain, and the safe extraction of the device without causing damage to brain tissue.

The FDA’s approval on Thursday arrives at a time when U.S. lawmakers are urging regulators to investigate whether the composition of the panel overseeing animal testing at Neuralink contributed to flawed and hastily conducted experiments. 

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Revolutionizing Implants and Advancing Healthcare

Elon Musk’s brain implant business, Neuralink, declared on Thursday that it has been given FDA approval to start its first clinical study on humans.


Additionally, the U.S. Department of Agriculture’s Inspector General is investigating potential violations of the Animal Welfare Act, prompted by a federal prosecutor’s request, which governs the treatment and testing of certain animals. The probe also encompasses the USDA’s oversight of Neuralink.

Neuralink, in a tweet on Thursday, stated that it is not yet prepared for a clinical trial and expressed gratitude for the collaborative efforts between its team and the FDA, emphasizing the significance of this initial milestone towards eventually assisting numerous individuals through their technology.

Over the years, Elon Musk has publicly shared an ambitious vision for Neuralink, including his statement late last year that he was confident enough in the safety of the devices to implant them in his own children. 

Musk envisions a future where both disabled and healthy individuals can readily receive surgical implants at local facilities, aiming to cure various conditions such as obesity, autism, depression, and schizophrenia, as well as enabling web browsing and telepathy.

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