This episode examines the regulatory boundaries between Harrison.ai’s twelve FDA cleared imaging triage modules and its unapproved generative radiology copilot, the operational impact of CMS New Technology Add on Payment status and Series C capital on U.S. market entry, and emerging governance frameworks including the proposed Accelerated Radiology AI Pathway, the FDA’s first qualified AI drug development tool for MASH trials, IQVIA’s five pharmacovigilance governance strategies, and the Sodium Dichloroacetate rare disease petition that tests accelerated approval mechanisms when trial enrollment faces structural barriers.
