TransMedics集团获FDA完全无条件批准开展新一代OCS心脏增强试验

美股速递
Feb 09

TransMedics集团宣布,其新一代器官护理系统(OCS)心脏增强试验已获得美国食品药品监督管理局(FDA)的完全无条件试验性器械豁免(IDE)批准。这一关键监管里程碑为该公司推进心脏移植领域的前沿研究铺平道路,有望为终末期心衰患者带来革新性治疗方案。

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