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In this week’s Pathways Picks: Breakthrough devices will lose streamlined path to add-on payments, and more Medicare updates; FDA details MDUFA VI user fee amounts; UK defines when an AI scribe is a medical device; registering trials in Canada; and more global medical policy updates.
After several ultra-challenging years for Integra LifeSciences, Chair and shareholder Stuart Essig is stepping back into the CEO role, with ambitions to accelerate the company’s turnaround. Wall Street remains wary, despite Essig’s previous successes.
CMS reiterates its plan to cancel the streamlined path. Excerpted from Pathways’ Picks June 8: MDUFA Agreement, Medicare Plans, EU Parliament Response, and More.