This episode examines the FDA’s formalization of single-trial evidentiary standards for new drug applications, supported by confirmatory evidence including mechanistic data, real-world evidence, and computational modeling. The briefing reviews three five ten k clearances for GE Healthcare MRI systems integrating deep learning reconstruction algorithms designed to reduce scan times and improve image quality. The episode concludes with the appointment of Rick Abramson as director of the Digital Health Center of Excellence, following January policy adjustments that altered regulatory pathways for clinical decision-support AI and expanded wellness product exemptions from premarket review.
