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In this week’s Pathways Picks: The first two devices have been recommended to undergo EU-side joint clinical assessments; six products have been chosen for Europe’s breakthrough device pilot; the slow transition to the MDR/IVDR continues; Shuren joins MedTech Innovator; AdvaMed appointments; updates from Canada, Australia, and India; and more.
Now that renal denervation is FDA-approved, Medicare-covered, and guideline-recommended, Medtronic is investing in additional research to show it does more than just reduce blood pressure.
Medicare’s phased-in elimination of the inpatient only rule and simultaneous expansion of the list of procedures it covers in ambulatory surgery centers are forcing medical device manufacturers to rethink where and how much they get paid.