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In this week’s Pathways Picks: The EU finalizes tighter requirements for notified bodies, with compromises from an earlier proposal; Europe’s breakthrough device pilot launches; digital labeling initiative; UDI in EHRs; eSTAR clarifications; FDA upgrades AI and data tools; China trial exemptions; structured submissions in Canada; and more.
In medical devices, the path to market is often shorter and more visible than in therapeutics, but that does not make investing straightforward. The challenge shifts earlier from science to commercialization, reimbursement, and buyer fit, and survival is far more common than meaningful liquidity. Can disciplined screening improve angel outcomes? Alex Pederson and Yaniv Sneor, Mid Atlantic Bio Angels,
CMS advances novel payment models in orthopedics. Excerpted from Pathways’ Picks April 15: New Medicare Directions, AI Picks, and Global Regulatory Updates