Market Pathways covers the people, challenges, and opportunities impacting the global medtech regulatory, reimbursement, and policy communities. We invite you to explore our coverage. Think Strategically.
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In this week’s Pathways Picks: Key takeaways from MDMA's annual meeting in DC, including the first post-Trump public appearance by the CDRH director and comments from a top CMS official on medtech coverage; CDRH FOIA staff returns, while industry educators never left; Switzerland pursues efforts to rely on US FDA; and more global medtech policy news.
The recently enacted European Health Data Space Regulation could expand data access horizons but also raise serious data protection issues for device companies. We explore the EHDS and its medtech implications, with insights from health data expert Cécile van der Heijden, from Axon Lawyers.
FDA’s device center lost more than 200 people in the large-scale reduction-in-force action advanced April 1, and many more have left in a steady stream of retirements and resignations under pressure by the Trump administration. Here’s a roundup of what we know about the people and functions lost at CDRH, and possible next shoes to drop, including review impacts and user-fee program risks. (Pictured: Building 66, FDA's White Oak Campus) Updated May 6