According to reports, the FDA rejected Neuralink’s request to start human testing. This was an unexpected obstacle that disappointed Elon Musk.
According to the well-sourced report, the company submitted a bid for human testing in 2022. However, it was denied due to numerous concerns. The implant’s “neural lacing” could move through the brain’s soft tissues; it could overheat; the battery could explode, and removal could cause permanent brain damage.
These concerns are completely rational, and medical devices with potential safety problems can often be rejected because their makers didn’t test them properly or hoped regulators wouldn’t notice them.
One usually returns to work and attempts again one year later. This may be the case at Neuralink. However, Reuters sources do not suggest anyone tearing up or wailing about their luck. Some do report being consternated by Musk’s slow pace of development.
The FDA has a right to be concerned: Neuralink is proposing a completely new in-body electronic system and introducing a new robotic method of implanting. Additionally, the FDA has cited the company for animal cruelty. Although this part of the process is unavoidably cruel, there are guidelines on what tests can be done on animals. However, Neuralink has surpassed those barriers to make faster progress.
Leaders have left the company for various reasons; one co-founder has decided to leave to start Precision Neuroscience, a brain implant company that just raised $41 Million.
Like Musk’s other companies, it is difficult to measure progress and setbacks as Neuralink is very secretive. They only share progress through carefully planned events. Although a video of a functioning implant in a happy monkey shows promise, it is not proof that the technology is ready for human testing. When a company continually responds with promises of “soon, very soon” for years while also having been denied approval by regulators, it’s natural for us to begin to question the integrity of their statements.
Many companies in this field have been working for years without Musk making any promises. Although this technology is potentially a breakthrough for those with debilitating conditions in its various forms, it poses a real risk to the brain by putting the foreign matter into it. The FDA wants companies to prove that implants are safe to pursue lofty goals such as restoring sight or mobility.
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