KORU Medical Systems获FDA 510(K)批准用于输注Rystiggo®,扩大Freedomedge®输液系统适应症范围

美股速递
Jan 30

KORU Medical Systems近日宣布,其Freedomedge®输液系统已获得美国食品药品监督管理局(FDA)的510(K)许可,可用于输注Rystiggo®(Rozanolixizumab-Noli)。这一批准标志着Freedomedge®输液系统的标签得到重要扩展,为其在特定药物输送领域的应用开辟了新途径。

此次许可不仅强化了KORU Medical Systems在医疗设备领域的创新地位,也为患者提供了更高效、便捷的治疗方案。公司表示,这一进展将进一步提升其在专业输液解决方案市场的竞争力。

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