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- China clamps down on investigator-initiated clinical trials, tightening oversightChina has announced tighter oversight of investigator-initiated trials (ITTs), requiring these studies to obtain approval from the National Medical Products Administration before they can begin. Th…
- Abiomed and Oscor advise correction of Impella catheter introducers due to leakage riskAbiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…