Neuralink has not received FDA clearance to test its brain implants in humans. The FDA remains overly concerned about potential risks.
Despite repeated and brash pronouncements by its CEO, Elon Musk, the idea of seeing brain-computer interface (BCI) startup Neuralink turn it into a commercial product is still a long way off. And a recent statement by Reuters makes that possibility even less likely. The company would really suffer if the Food and Drug Administration (FDA) refused in 2022 to start human trials of its chips, which have killed so many pigs in the past.
Neuralink did not have FDA clearance to test its brain implants in humans.
“The agency’s main security concerns are related to the lithium battery; the risk of tiny implant wires migrating to other areas of the brain; and questions about how to remove the device without damaging brain tissue,” former and current Neuralink employees told Reuters.
When it comes to the battery system and its innovative transdermal charging capabilities, the FDA fears the process will be misguided. The agency wants to be sure the battery is “very unlikely to be defective,”according to Reuters, because otherwise the discharge of electrical current or heat if the battery ruptures could burn surrounding tissue.
FDA remains overly concerned about potential risks
The FDA is also concerned about potential problems if the entire device has to be removed, whether for replacement or upgrades, due to the tiny size of the electrical wires that penetrate the patient’s gray matter. These threads are so thin and delicate that they can break during implant removal (and even during normal use), and then migrate to other areas of the brain where they can get stuck in something important.
During the Neuralink event last November, Elon Musk claimed with great certainty that the company would receive this approval from the FDA “within six months”, in other words, by the spring of this year. This estimate seems to be just as reliable as other predictions, such as the start date for the production of the Cybertruck. “He can’t tell himself it’s not a deal,”one employee told Reuters. “This is the human brain. This is not a toy”. Neuralink declined to comment on this topic.