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FDA 已延长对用于治疗早期乳腺癌的 ProSense 冷冻消融系统的审查时间
FDA 延长了 ProSense 冷冻消融系统 De Novo 上市许可申请的审查期,预计将在 2025 年第一季度后就 ProSense 用于内分泌治疗早期低风险乳腺癌做出授权决定。 此更新来自 FDA 和 IceCure Medical 之间持续的讨论,标志着对这项创新技术的持续和彻底评估。
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