Recent layoffs at the FDA, which included approximately 20 employees from the office responsible for reviewing medical devices, have raised concerns about the agency's capacity to evaluate clinical-trial applications from Neuralink. Sources indicated that the cuts were part of a broader federal workforce reduction and not specifically targeted at Neuralink personnel. Experts warn this decrease in staffing could hinder the FDA's ability to safely manage medical device applications and jeopardize the safety of ongoing trials, particularly for vulnerable patients participating in Neuralink's research on brain-computer interfaces.
The loss of roughly 20 employees will hamper the agency's ability to quickly and safely process medical device applications of all sorts, including Neuralink's.
We should be worried about the whole trial, and the protection of the people in the trial.
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