On Wednesday, Neuralink introduced the first human subject to receive the company’s brain implant, a 29-year-old man who has been paralyzed from the shoulders down for eight years after a diving ...
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence ...
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing ...
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