Elon Musk's Neuralink Gets FDA Approval For Human Trials

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Elon Musk's brain implant firm Neuralink said it has received approval from the U.S. Food and Drug Administration to conduct first-in-human clinical trials.

In a tweet, Neuralink said, "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study! This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people."

The company, which is developing implantable brain-computer interfaces, said it is yet to open recruitment for clinical trials and will announce more information on this soon.

Musk co-founded the neurotechnology company in 2016 to develop brain implants with hopes to help the paralyzed walk, the blind see and to help treat brain diseases like Parkinson's, dementia and Alzheimer's.

Since 2019, Musk was hoping that Neuralink would get FDA approval for human trials.

Previously, the FDA rejected a 2022 application to pursue human clinical trials, citing major safety concerns. The agency reportedly was concerned about the device's lithium battery, the chances for the implant's tiny wires to migrate to other areas of the brain, and questions about removing the device without damaging brain tissue.

Since then, the company has been working to resolve concerns expressed by the FDA over the safety of the implant.

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