Neuralink, a company owned by Tesla and SpaceX CEO Elon Musk, is seeking to hire both a Clinical Trial Director and Coordinator, hinting that human testing for its series of brain implantation chips could be imminent.
In August 2020, Musk and Neuralink engineers unveiled the v0.9 device. The small “chip” could be integrated into the human brain to solve a variety of problems, including depression and anxiety, blindness, paralysis, seizures, and other neurological disorders. “It’s like a FitBit in your skull with tiny wires,” Musk half-joked during his presentation. “I could have it right now and you wouldn’t even know. Maybe I do!”
In July of the same year, the Food and Drug Administration (FDA) presented Neuralink with a “breakthrough device designation,” hinting that the technology was on the rise from lofty idea to a potentially groundbreaking medical device that could solve the medical conditions of hundreds of thousands of people, and for an affordable price. However, since the presentation, not much has come from Neuralink as development has been quiet but ongoing. Musk hinted that human trials could begin in 2021, but it appears that the company may be preparing for that to occur this year instead.
Initially spotted by Bloomberg, Neuralink placed two new job postings related to the introduction of potential human trials. The company is seeking both a Director and a Coordinator for the trials. The director will “work closely with some of the most innovative doctors and top engineers, as well as working with Neuralink’s first Clinical Trial participants,” the posting says.
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Meanwhile, the Coordinator will “help build the team responsible for the heavy operational activities and regulatory activities that come with a fast-paced and ever-evolving environment.” The Coordinator will have an extensive list of duties, which includes “monitoring visits to review and assure the rights, welfare, and safety of study subjects are protected, and ensure integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of eCRFs, source documents, medical records, and regulatory documents.”
The v0.9 device unveiling included a display of how the chips work on pigs. The implanted chip was able to accurately predict brain activity in the animals and required no invasive procedures for implantation. Getting a Neuralink should take less than an hour, without the need for general anesthesia. Users could have the surgery done in the morning and go home later during the day.
There is no evidence to suggest that Neuralink’s devices have been approved for human trials by the FDA, yet. Bloomberg notes that no Neuralink trials are posted on any official government website.
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