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The Regulatory Landscape: Navigating FDA Classification and Certification for AI-Powered Clinical Decision Support Systems
A major trend dominating the Clinical Decision Support Systems (CDSS) Market is the pivot toward personalized medicine, driven by the increasing availability and integration of patient-specific genomic and proteomic data. Traditional CDSS recommendations were based on population-level evidence, but the new market reality requires systems that can interpret a patient's unique genetic profile to...
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