According to a new Reuters investigation, despite the frequent and brazen statements of its sometimes CEO, Elon Musk, the possibilities of brain-computer interface (BCI) firm Neuralink bringing a product to market remain remote. The FDA allegedly refused the BCI business permission to perform human trials in 2022 using the same technology that killed all those pigs — basically, pig slaughter.
“The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue,” current and former Neuralink employees told Reuters.
The FDA’s reservations about the battery system and its innovative transdermal charging capabilities centre on the device’s failure rate. According to Reuters, the FDA is looking for assurances that the battery is “extremely unlikely to fail,” because a ruptured pack’s release of electrical current or heat energy might destroy the surrounding tissue.
Due to the small size of the electrical lines that reach into the patient’s grey matter, the FDA is also concerned about possible complications if the device needs to be removed wholesale, either for replacement or updates. The leads are so little and sensitive that they risk breaking off during removal (or even normal use) and migrating to other sections of the brain, where they may become trapped in something essential.
Musk boldly asserted during Neuralink’s open house last November that the business will obtain FDA clearance “within six months,” or by this spring. His estimate is proving to be as accurate as his predictions for when the Cybertruck will go into production. “He doesn’t understand that this isn’t an automobile,” one employee told Reuters. “This is a human brain. It’s not a toy.” Requests for comment were not returned by Neuralink.
