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美国食品和药物管理局批准雅培 CGM 在医学影像检查中使用
2024-12-10 17:22  浏览:55
Abbott (NYSE:ABT) today announced a significant regulatory milestone that could make common medical procedures easier for people with diabetes.
雅培公司(NYSE:ABT)今天宣布了一项重要的监管里程碑,它将使糖尿病患者更容易进行常见的医疗程序。

Our sister site, Drug Delivery Business News, reports today that the FDA cleared the removal of the imaging contradiction for the FreeStyle Libre 2 and 3 continuous glucose monitors (CGMs) for procedures like X-rays, CT scans and MRIs. Abbott said it makes its systems the first and only patient-applied CGM sensors approved for these screenings.
我们的姊妹网站《给药商业新闻》(Drug Delivery Business News)今天报道,美国食品及药物管理局(FDA)批准取消
FreeStyle Libre 2
3 血糖监测仪(CGM)在 X 射线、CT 扫描和核磁共振成像(MRI)等程序中的成像限制。雅培表示,这使其系统成为首款也是唯一一款获准用于这些检查的患者应用 CGM 传感器。

Imaging procedures often come as part of diabetes care, Abbott said, especially as diabetes can cause a number of medical complications. The company rigorously tested its Libre 2 and 3 sensors to ensure they remain effective after radiologic procedures. This FDA clearance comes with no changes made to the sensor, too.
雅培公司表示,成像程序通常是糖尿病护理的一部分,尤其是糖尿病会引起一系列医疗并发症。该公司对 Libre 2 3 传感器进行了严格测试,以确保它们在放射治疗后仍然有效。此次通过 FDA 认证,传感器也未做任何改动。