FDA rejects Elon Musk’s request to explore brain implants in people for safety reasons

In 2016, Musk established Neuralink. Since then, the billionaire has made audacious promises about the technology’s potential, touting it as a means of treating diseases like paralysis and blindness as well as a tool to transform people into cyborgs that are better able to compete with artificial intelligence.

According to reports, Neuralink has sought to conduct a first-in-human clinical trial to determine whether the implant can assist persons with disabilities. According to Reuters, which cited three persons who had read the FDA’s letters, the FDA acknowledged a danger that the device’s wires may travel to other parts of the brain and cause inflammation, which might reduce the implant’s effectiveness and need its removal. Neuralink talked about some of the issues last year in public.

They do pose some fantastic questions. The thermal benchtop testing of our implant is one of the other issues. It is crucial that our implant does not overheat and harm the surrounding tissue. For that reason, it is crucial to have highly thorough and reliable bench testing. In order to make it even more precise, we are revamping it. These pose a lot of challenging concerns about biocompatibility chemical characterisation, according to Jeremy Barenholtz, director of Neuralink’s brain interface software department, at the time.

According to Reuters, the FDA reportedly requested further animal evidence regarding the failure risk of the lithium battery used by Neuralink, which can be recharged remotely. While Neuralink has conducted pig studies to address some of the FDA’s concerns, it has not yet received approval to move forward through the clinic.

Another problem is device removal. The ability to upgrade the device is essential to Musk’s vision; during a presentation last year, he declared, “I’m pretty sure you would not want an iPhone 1 stuck in your head with the iPhone 14 is available.” However, the FDA is concerned that the removal of the implant could harm brain tissue, according to Reuters.

At its presentation in November, Neuralink acknowledged that removal and replacement is a “tough problem” that it hasn’t yet figured out. It noted that the root of the difficulty is the tissue that develops over the device’s surface as the body heals.

“Reducing the procedure’s invasiveness has led to our greatest triumphs. We preserve the dura, keeping the body’s natural barrier of protection in situ, as opposed to directly exposing the brain surface. This avoids encapsulation at the brain’s surface, according to a presentation by mechanical engineer Alex Wood-Thomas of Neuralink. We were very close to simply pulling out an implant and replacing it with a new one in the same spot. Neuralink is designing a system to address the new imaging issues the method raises.

Uncertainty exists on when the FDA’s concerns will be addressed. Musk anticipated Neuralink would be approved in the spring at the end of last year, but he has a track record of missing deadlines for entering human testing.