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- 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,…
- Early regulatory operations planning key to submission-ready dossiersRegulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…