雅培公司宣布，其新一代Ultreon™ 3.0人工智能冠状动脉成像平台已正式获得美国食品药品监督管理局（FDA）的上市许可，并同步取得欧盟CE认证标志。这一突破性进展标志着该AI驱动血管成像系统同时获得全球两大核心医疗市场的准入资格。
该平台融合了先进的人工智能算法与光学相干断层扫描技术，能够为临床医师提供更精准的血管腔内影像评估方案。通过智能化的斑块性质分析、支架贴壁评估及血管尺寸测量功能，系统可辅助医生优化冠状动脉介入治疗决策流程。
此次双认证的落地，不仅体现了监管机构对雅培创新成像技术安全性与有效性的认可，也为全球更多冠心病患者带来精准诊疗的新机遇。作为血管内影像领域的重大升级，Ultreon™ 3.0平台有望重塑心血管介入治疗的标准范式。
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