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In this week’s Pathways Picks: CMS plans to reverse bonus payment fast track for Breakthrough Devices, and advances novel payment models in orthopedics and digital health; FDA is slow on TEMPO responses while exempting AI exemption petition; UK ups AI sandbox investments; and more regulatory updates from FDA and the EU.
Heart failure isn’t just a failing heart—it’s a system in revolt, where heart, lungs, kidneys, lymphatics, and blood vessels conspire to fuel decline. Next-gen heart failure start-ups tap into physiological mechanisms to bring order back to the system. We profile Levron Cardiovascular, Ventric Health, and WhiteSwell.
User fees would bankroll more than half of the FDA’s FY2027 budget request. Excerpted from Pathways’ Picks April 7: Shuren Venture Fund, MDUFA Agreement, Global Digital Health Updates.