Elon Musk'sMusk's brain-implant company, Neuralink, has achieved a major milestone with the green light from the FDA to begin its first-in-human clinical trial. This approval marks a critical turning point for Neuralink, which faced earlier obstacles in obtaining regulatory clearance.
Musk had been hoping for human trials of Neuralink's brain implant, which has the potential to address severe conditions like paralysis and blindness, since 2019. Although Neuralink was established in 2016, it wasn't until early 2022 that Neuralink started the process for FDA approval. Regrettably, the agency rejected their application, according to information shared by seven current and former employees with Reuters in March.
The FDA had raised several concerns that needed to be resolved before granting human trials, the employees said. The lithium battery of the implant, the potential migration of wires into the brain, and the safe extraction of the device without causing brain damage were among the concerns.
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The FDA's recent approval comes amidst increasing pressure from US lawmakers pushing for regulatory authorities to investigate potential issues with the panel overseeing the animal testing at Neuralink, which may have resulted in rushed and flawed experiments. A federal probe has already been launched into Neuralink, with the US Department of Agriculture's Inspector General conducting an investigation into possible violations of the Animal Welfare Act at the request of a federal prosecutor. The probe has also scrutinised the USDA's involvement in Neuralink's investigation.
While the FDA's approval of the drug is a significant step forward, Neuralink said in a tweet that it is not yet ready for a clinical trial. The company recognized the collaborations between its team and the FDA, emphasising the importance of this milestone in paving the way for their technology to benefit numerous individuals in the future.
Elon Musk has long proposed a bold vision for Neuralink, which attracted attention when he declared his faith in the devices' safety, even to the extent of being willing to implant them in his own children. Musk is looking for a future in which both disabled and healthy individuals can easily receive surgical implants at local clinics. The implants are designed to address a variety of conditions, including obesity, autism, depression, and schizophrenia, while also enabling capabilities such as web browsing and telepathy.
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