Elon Musk’s Neuralink says FDA has given nod to kickstart first human trials

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The US Food and Drug Administration (FDA) has approved Elon Musk's brain-implant company Neuralink to begin its first-in-human clinical study.

The company announced the milestone in a Twitter post, which stated, "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." However, the regulator is yet to comment on this.

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…

It was difficult for the company to obtain approval for the human trials. Concerned about the implantable brain device's lack of safety, the FDA had denied the company's application to begin human clinical trials in early 2022.

The FDA outlined several key issues, including the "use of lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue."

There's more. Neuralink has been accused of abusing animal test subjects, and for flouting biohazard rules. In May, US lawmakers urged regulators to look into the rushed animal testing for the device. Reuters obtained the information from the company's internal employees.

In addition, the US Department of Transportation is conducting an independent investigation into the illegal transport of chips that were implanted in monkey brains. According to the report, the implanted chips were removed without proper containment measures and may have harbored dangerous animal pathogens. The Department of Agriculture's Office of Inspector General had launched an investigation into potential violations of the Animal Welfare Act. Since 2018, the company has claimed the lives of 1,500 animals, including over 280 sheep, pigs, and monkeys, in the name of research.

The organization was founded in 2016 to cure a wide range of diseases, including paralysis, autism, depression, and schizophrenia. It also has an ambitious plan to restore people's vision and movement by connecting their brains to computers. The chips work on the basis of interpreting brain signals and sending information back to computer devices via Bluetooth.

Musk has consistently exaggerated the timeline of events. Initially, the goal was to begin implanting chips in human brains in 2020, and then later it was postponed to 2022. Musk has been seen stating that human trials for the company's brain implant device will begin in 2019. According to the report, the company only sought FDA approval in early 2022.

Musk also made headlines when he said to implant the device in his own children, as he was "so confident in the device's safety."

Meanwhile, the company has not revealed many details about the trials. According to a Twitter post, the company hasn't started recruiting volunteers, but more information will be available soon.