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Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The June 2025 cover features the European Commission headquarters in Brussels. Here we spotlight points of interest for the EU Act Act and the Medical Device and IVD Regulations.
To understand how changing guidelines and clinical practice have impacted TAVR’s utilization compared to SAVR across age groups over the last decade and what they portend for the future, Health Advances conducted a comprehensive analysis of real-world data of US aortic valve replacement procedures.
FDA will hold a meeting in early August to discuss recommendations for a renewed user fee program. Excerpted from Pathways’ Picks June 11: MDUFA Meeting, Companion Dx 510(k)s, Next-Gen Sequencing in China, and More.