Elon Musk’s company, Neuralink, is known for its groundbreaking work in brain-computer interface technology. However, the US Food and Drug Administration (FDA) has denied the company human trials for its brain implants.
Why FDA rejected brain implant human trials?
Safety Concerns of the FDA According to former and current employees of Neuralink, the FDA denied the company’s request due to several safety concerns. The agency expressed concerns over the device’s lithium battery, the potential for the implant’s tiny wires to migrate to other areas of the brain, and questions regarding the device’s removal without damaging brain tissue.
The Risk of Implant Failure The FDA is looking for reassurance that the battery is “very unlikely to fail” after being implanted. The agency wants to ensure that the device’s discharge of electrical current or heat energy from a ruptured pack won’t lead to the burning of surrounding tissue.
Potential Risks on Device Removal Another issue the FDA is concerned about is the small size of the electrical leads that extend into the patient’s brain. There could be potential risks if the device needed to be removed for upgrades or replacements.
Employees’ Concerns One employee of Starlink, a subsidiary of Neuralink, expressed concerns about the FDA’s decision. He stated, “He can’t appreciate that this is not a car. This is a person’s brain. This is not a toy.”
In short, the FDA has denied Neuralink’s request for human trials due to several safety concerns. The agency wants to ensure the safety of the device’s battery, potential wire migration, and removal without damaging brain tissue. Employees of the company also share concerns regarding the safety and use of such a device on human brains.
This is the best thing to do as this is very risky. However, it will be fun to see how Elon Musk counters this issue because we know for sure one day this is going to take place.