FDA Output
FDA Output, July 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in July 2025. Updated July 14.
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Perspective & Commentary
TAVR Patients Get Younger as Technology Ages
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.
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Regulatory & Reimbursement
Pathways' Pick of the Week: MDUFA VI Reauthorization to Commence
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.