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In this week’s Pathways Picks: HHS Secretary Kennedy hints about work on Breakthrough Device coverage policies; Kenya publishes a forward-leaning AI guidance; Europe updates its guides on risk classifications and borderline products; and more from South Korea and US policy groups.
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.
Next-gen start-ups treat heart failure tap into physiological mechanisms to help patients. Excerpted from our recent feature article.