About 20 employees from the Federal Drug Administration’s Office of Neurological and Physical Medicine Devices were fired. Officials said that included some involved with Neuralink.
The layoffs raised concerns about the FDA’s ability to safely process medical device applications, according to external experts and sources familiar with the matter.
Concerns were expressed that the layoffs could be intimidating for the FDA professionals overseeing Neuralink’s trial, raising worries about trial safety.
Neuralink is testing its device that enables paralyzed individuals to control digital devices with their thoughts, having received FDA approval for its first human clinical trial in May 2023.