04/15/26 - FDA Lifecycle Guidance for AI Devices, Administrative Automation Capital Concentration, AI-Discovered Antifibrotic in

04/15/26 - FDA Lifecycle Guidance for AI Devices, Administrative Automation Capital Concentration, AI-Discovered Antifibrotic in

Episode description

This episode examines the operational and regulatory landscape of clinical AI deployment in twenty twenty-five. We cover the FDA’s Total Product Life Cycle guidance for AI-enabled medical devices, the concentration of venture capital in administrative automation and clinical documentation tools, the deployment gap between large health systems and smaller providers in clinical decision support, and the first AI-discovered drug compound to advance into phase 2a trials. The briefing also addresses brain-computer interface production scaling and the reimbursement bottlenecks constraining digital therapeutics despite regulatory approval. Listeners gain a structured view of where capital, regulatory clarity, and operational adoption are converging in healthcare AI infrastructure.

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