According to a recent Reuters story, the chances of brain-computer interface (BCI) firm Neuralink commercialising a product remain remote despite the company’s occasionally CEO Elon Musk’s repeated and bold promises. According to reports, the FDA denied the BCI company’s request for permission to undertake human trials in 2022 using the same equipment that killed all those pigs, specifically because of pig killing.
According to current and former Neuralink employees who spoke to Reuters, “the agency’s major safety concerns involved the device’s lithium battery, the potential for the implant’s tiny wires to migrate to other parts of the brain, and questions over whether and how the device can be removed without harming brain tissue.
The FDA’s worries about the battery system and its new transdermal charging capabilities centre on the likelihood that the apparatus would malfunction.
U.S. regulators REJECTED Elon Musk’s bid for Neuralink to test brain chips in humans pic.twitter.com/xHdIWfMbVa
— Los Angeles Magazine (@LAmag) March 3, 2023
The agency is looking for evidence that the battery is “extremely unlikely to fail,” according to Reuters, because if it did, the release of electrical current or heat energy from a ruptured pack might fry the nearby tissue.
FDA Is Concern About The Damage It Would Make While Removing From Brain
Due of the tiny size of the electrical leads that extend into the patient’s grey matter, the FDA is also quite worried about potential issues should the device need to be removed entirely, either for replacement or updates. These tiny, fragile leads run the danger of breaking during removal (or even during routine use), moving to distant areas of the brain, where they might become ensnared in something crucial.
Musk boldly asserted at Neuralink’s open house in November of last year that the business will obtain FDA certification “within six months,” or essentially by this spring. That estimate is turning out to be as accurate as his predictions for the potential launch date of the Cybertruck.
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He is unable of understanding that this is not a car, a worker told Reuters. “This is an individual’s brain. It’s not a toy, though. When contacted for comment, Neuralink did not provide any.
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