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The Medicare agency finalized plans to cancel its “alternative pathway” to new technology add-on and device pass-through payments for FDA Breakthrough Devices. However, it agreed to add a transitional period allowing firms to access the streamlined route for the next two years if they get a breakthrough designation by September.
XVIVO is chipping away at the enormous unmet demand for heart transplants with hypothermic oxygenated perfusion preservation technology.
The agency outlines new centralized operations. Excerpted from Pathways Picks July 29: FDA Consolidation, User Fees Rise, South Korea Streamlines .