KORU Medical Systems已正式向监管机构提交510(k)申请，旨在为其Freedomedge®系统与一款已商业化的肿瘤生物制剂联合使用获取市场准入许可。此次申报标志着该创新医疗器械在肿瘤治疗领域的应用迈出关键一步。
Freedomedge®系统的技术优势与肿瘤生物制剂的精准疗法相结合，有望为临床治疗提供更高效、便捷的解决方案。此次提交的510(k)申请材料包含详实的性能验证数据与临床前研究结果，充分论证了该联合方案的安全性与有效性。
若获得批准，该组合方案将拓宽Freedomedge®系统在肿瘤支持性护理领域的应用场景，为患者提供更优化的药物输注体验。公司将持续跟进审批进展，并及时向市场披露重要节点信息。
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