Digital Edition: Market Pathways April-May 2025
How EBR Systems navigated the COVID pandemic and recent CDRH layoffs in its quest to gain FDA approval for its heart failure device. Building a methodological framework to align clinical expectations with different device types in MDR/IVDR; Tips for dealing with the DOGE-era FDA, plus the latest on people and functions lost at CDRH; and a look at the new European Health Data Space Regulation.
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