Apr 3, 2023 07:30 PM
(This post was last modified: Apr 4, 2023 02:40 AM by C C.)
Facing animal-abuse investigations, Elon Musk’s neurotech company is stumbling
https://spectrum.ieee.org/neuralink-seeks-fda-approval
EXCERPTS: Neuralink, the neurotechnology company founded by Elon Musk, is at best having a rough initial go-round with the Food and Drug Administration’s human-trials application process. The company also faces additional investigations by two other U.S. government agencies. These setbacks and the broad, cure-all expectations that its founder has placed on the company’s neural implant could now incite increased scrutiny from regulators. By contrast, however, other neurotech companies have, to date, managed largely to avoid such intense regulatory scrutiny.
[...] Ongoing investigations will not likely factor directly into how the FDA evaluates the data in Neuralink’s next IDE application, but it will likely complicate the process. Data from diseased animals and contaminated equipment may need to be rejected, says Victor Krauthamer, visiting professor of biomedical engineering at George Washington University and the former acting director of the FDA’s Division of Neurological and Physical Medicine Devices. “If the experiments are tainted in some way, then the FDA may require new data. If the animal studies are questionable, they will have to be redone,” he says.
Further complicating Neuralink’s application are the many claims Musk and other company representatives have made regarding The Link’s purportedly extensive list of capabilities... (MORE - missing details)
https://spectrum.ieee.org/neuralink-seeks-fda-approval
EXCERPTS: Neuralink, the neurotechnology company founded by Elon Musk, is at best having a rough initial go-round with the Food and Drug Administration’s human-trials application process. The company also faces additional investigations by two other U.S. government agencies. These setbacks and the broad, cure-all expectations that its founder has placed on the company’s neural implant could now incite increased scrutiny from regulators. By contrast, however, other neurotech companies have, to date, managed largely to avoid such intense regulatory scrutiny.
[...] Ongoing investigations will not likely factor directly into how the FDA evaluates the data in Neuralink’s next IDE application, but it will likely complicate the process. Data from diseased animals and contaminated equipment may need to be rejected, says Victor Krauthamer, visiting professor of biomedical engineering at George Washington University and the former acting director of the FDA’s Division of Neurological and Physical Medicine Devices. “If the experiments are tainted in some way, then the FDA may require new data. If the animal studies are questionable, they will have to be redone,” he says.
Further complicating Neuralink’s application are the many claims Musk and other company representatives have made regarding The Link’s purportedly extensive list of capabilities... (MORE - missing details)
