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Neuralink, Elon Musk’s brain implant firm, is hiring a clinical trial director.

By Bloomberg

Elon Musk’s brain implant company Neuralink is now hiring a clinical trial director, an indication that the company’s longstanding goal of implanting chips in human brains is coming closer.

The trial director position would oversee the startup’s long-promised human trials of its medical device, according to the listing. Neuralink’s brain implant — which Musk has said already allows monkeys to play video games with their thoughts alone — is intended to help treat a variety of neurological disorders, such as paralysis.

The job description for the position, based in Fremont, California, promises that the applicant will “work closely with some of the most innovative doctors and top engineers” as well as with “Neuralink’s first Clinical Trial participants.” It also indicates that the job will mean leading and building “the team responsible for enabling Neuralink’s clinical research activities,” as well as adhering to regulations.

Last month, Musk told the Wall Street Journal that Neuralink hoped to implant its device in human brains sometime in 2022. However, he has made similar predictions in the past that proved overly optimistic — including in 2019, when he said during a presentation that the device would be in human skulls by the following year.

The first in-human test that medical device makers must go through on the path to U.S. Food and Drug Administration approval is known as a feasibility test. The next, after a submission, review and approval process with the FDA based on the feasibility test, is a pivotal device test.

It isn’t clear precisely where Neuralink is in the process. Representatives for Neuralink and the FDA didn’t respond to requests for comment. Generally, device makers hire trial directors early in their interaction with the FDA, to help design trials in a way that would maximize the chances of FDA approval. Neuralink doesn’t appear to have human trials posted on clinicaltrials.gov, but postings there can lag recruitment of the first patients.

Last year, another company working on brain-machine interfaces, Synchron, said the FDA had approved its planned feasibility study. Synchron is currently in the recruiting stage, a spokeswoman said.

Neuralink is also advertising for a Fremont-based clinical trial coordinator, as well as several other positions.

To contact the author of this story:
Sarah McBride in San Francisco at [email protected]

Source: Al Jazeera

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