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Parallel actions notably a February 2025 FDA warning letter to Exer Labs (an AI-based medical device) also emphasized that AI increases the Agencys scrutiny of quality systems rather than providing regulatory cover ( [6] ) ( [7] )

Upregulated gene sets included those associated with GPCR signaling, neuropeptide receptor interactions and ligand binding, cilia formation, metabolic processes, and endocrine function Supplemental Figure 5B)

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