Neuralink human testing has reportedly already received one FDA rejection

by Ana Lopez

from Neulink ambition to provide a brain-computer interface orders of magnitude better than what’s out there today met with headwinds at the FDA, That reports Reuters. The agency reportedly rejected the company’s application to begin human testing last year, a somewhat anticipated hurdle that nevertheless seems to have frustrated financier Elon Musk.

The well-researched report explains that the company made its bid for human testing in 2022, but was rejected with numerous concerns cited. The “neural lace” that forms the implant can migrate through the soft tissue of the brain; the device may overheat; the implanted battery may fail; removal under any circumstances of failure, rejection or infection can damage the brain.

Such concerns are perfectly rational, and it’s natural for medical devices to be rejected because of potential safety issues that the makers either failed to test properly or hoped the regulator wouldn’t notice. Usually people go back to work and try again a year later.

That might just be what’s happening at Neuralink; nothing the Reuters sources said suggests anyone is tearing their heart out and lamenting their bad luck. But some report Musk’s dismay at the slow pace of progress.

But the FDA is right to be wary: Not only is Neuralink proposing an entirely new in-body electronic system and even a new, robotic method of implantation, but the company has also been cited for cruelty in animal testing. This part of the process is, of course, inevitably cruel in a way, but there are guardrails to what testers ethically justify in animals, and Neuralink has reportedly surpassed them — possibly to make faster progress.

Executives have fled the company for some reason, one co-founder even left to start a new brain implant company, Precision Neuroscience, which just raised $41 million.

It’s hard to measure progress and setbacks because Neuralink, like Musk’s other companies, is very secretive and only shares progress in the form of occasional, carefully curated events. But a working implant in a seemingly happy monkey on video, while promising, is hardly evidence that the technology is ready for human testing. And when all we hear from the company is “soon, very soon” for years, despite apparently non-trivial rejection from regulators, we begin to have second thoughts.

Most of the companies working in this space have been doing this for years, right up to their FDA approval for human testing and use, without making the kind of promises Musk has made on behalf of Neuralink. This technology in all its forms represents a potential breakthrough for people with debilitating conditions, but introducing foreign substances, let alone a large portion of them, into the brain is fundamentally dangerous. For a company to pursue such lofty applications as restoring vision and mobility, it must first prove that the implants are safe on a basic level, which is what the FDA is reportedly asking for.

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