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Regulators in the EU, UK, and US already mandate the structured capture of medical device safety data. Now they are beginning to analyze it, and they expect device manufacturers to be doing the same. Existing capabilities, however, may hold companies back, warns Qinecsa’s Jonathan Messer.
Innovation in tricuspid valve therapies has long lagged other transcatheter heart interventions. But that gap is beginning to close. A deeper understanding of the disease—combined with the emergence of three first-generation devices now in clinical use—is accelerating progress. Start-ups are entering the field, though the pace remains more measured than the surge once seen in the mitral valve space. We interview Edwards Lifesciences, VDyne, TriCares and Innoventric.
The number of MDR submissions and certificates is trending up. Excerpted from Pathways’ Picks April 1: AI Act Deemphasized, MDR Numbers, Generative AI Approval, and More.