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Re:How Artificial Intelligence Gave a Paralyzed Woman Her Vo... by 5440 on Thursday August 24, 2023 @06:10PM (#37255235)
I have several of these devices in front of FDA on behalf of clients. I recommend anyone interested read the FDA guidance on the matter.

Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation Non-clinical Testing and Clinical Considerations

https://www.fda.gov/media/120362/download

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