Despite repeated bold claims by its sometimes-CEO Elon Musk, the prospects of brain-computer interface (BCI) startup Neuralink bringing a product to market remain dim, according to a new report from Reuters. The FDA apparently denied the BCI company clearance in 2022 to conduct human trials using the same devices that killed all those pigs, namely due to; pig slaughter.
“The agency’s primary safety concerns involved the device’s lithium battery, the possibility of the tiny implant wires migrating to other areas of the brain, and questions about whether and how the device can be removed without damaging the brain tissue,” said current and former Neuralink employees. said Reuters.
FDA’s concerns regarding the battery system and its novel transdermal charging capabilities revolve around the potential for device failure. According ReutersThe agency is seeking assurance that the battery is “very unlikely to fail” because if it did, the discharge of electrical current or thermal energy from a ruptured pack could fry surrounding tissue.
The FDA is also very concerned about potential problems should the device have to be removed entirely, either for replacement or upgrade, due to the tiny size of the electrical wires that extend into the patient’s gray matter. Those wires are so small and delicate that they risk breaking during removal (or even regular use) and then migrating to other parts of the brain where they could lodge in something important.
During Neuralink’s open house last November, Musk confidently stated that the company would get FDA approval “within six months,” basically this spring. That estimate is turning out to be about as accurate as his guesswork as to when the Cybertruck might finally go into production. “He can’t appreciate that this isn’t a car,” an employee said. Reuters. “This is a person’s brain. This is not a toy.” Neuralink did not respond to requests for comment.
All Engadget Recommended products are curated by our editorial team, independent of our parent company. Some of our stories include affiliate links. If you purchase something through one of these links, we may earn an affiliate commission. All prices are correct at the time of publication.
