12/29/25 - AI Imaging Transition to Operational Standard, FDA Expanded Access and Device Clearance Updates, Remote Monitoring In

This episode examines the operational transition of AI-powered diagnostic imaging from pilot deployments to clinical standard across U.S. health systems in 2025, including the workflow integration challenges, workforce development requirements, and change management investments that determined deployment success. The briefing covers FDA’s October 2025 expanded access guidance revisions clarifying physician-sponsor roles and IRB waiver procedures, alongside new premarket notification exemptions for radiology computer-aided detection devices. The episode also analyzes the infrastructure maturation that enabled remote patient monitoring to reach critical mass through actionable dashboards, alert fatigue reduction, and hybrid staffing models, while addressing the elevation of healthcare cybersecurity to board-level strategic priority following attacks on connected medical devices and operational technology.