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- Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus riskThe FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
- FDA advisory panel backs experimental Replimune melanoma therapy after two prior rejectionsAn FDA advisory committee voted 10‑to‑3 to recommend the use of an experimental Replimune treatment for patients with advanced melanoma. The panel’s recommendation marks a shift after the agency p…