This episode examines the February twenty twenty six implementation of the Quality Management System Regulation, which harmonizes U.S. device standards with ISO thirteen four eight five and integrates cybersecurity lifecycle requirements under Section five twenty four B. We cover the American College of Radiology’s formal comments on a manufacturer petition seeking optional five ten k exemptions for certain AI enabled computer aided detection devices, including recommendations for narrowed qualification criteria and mandatory third party registry participation. The briefing also addresses the FDA’s three new guidance documents on rare disease development pathways, including surrogate endpoint frameworks and adaptive trial designs for cell and gene therapies in ultra rare populations. Finally, we review recent AI device clearances from Qure.ai and Meddevice that demonstrate pattern recognition and procedural decision support in high volume diagnostic and interventional cardiology workflows.