Elucid 获 FDA 批准 FFR-IQ,实现冠脉斑块与血流动力学联合评估
Elucid Scores FDA Clearance for FFR-IQ to Unify Plaque Biology and Hemodynamics
Elucid 的 FFR-IQ 拿到了 FDA 许可,做一次冠脉 CT 就能同时看斑块和缺血,不用再做有创的血流储备分数检查了。
心血管影像 AI 公司 Elucid 的 FFR-IQ 软件获得 FDA 510(k) 许可(编号 K262015,2026 年 9 月 29 日批准)。该软件基于冠脉 CT 血管造影(CCTA)影像,无创估算血流储备分数(FFR)。其采用的 BioIntegrated FFR-CT 计算建模方法,将冠脉血管解剖结构、斑块组织形态与血流动力学整合在同一模型中。这让医生能在一次 CCTA 检查中同时评估斑块生物学特征和心肌缺血状况。
Elucid Scores FDA Clearance for FFR-IQ to Unify Plaque Biology and Hemodynamics
What You Should Know Cardiovascular imaging AI innovator Elucid has received U.S. FDA 510(k) clearance (K262015, authorized September 29, 2026) for FFR-IQ™, its software for the non-invasive estimation of fractional flow reserve derived from coronary computed tomography angiography (CCTA). Introduces BioIntegrated FFR-CT: a computational modeling approach that integrates coronary vascular anatomy, plaque tissue morphology, and ... Read More