Accurate and rapid assessment of sarcopenia in older adults through electrical impedance myography - Development of Regulatory Plans Supplement

项目总结 这一行政补充将为制定监管计划提供资金，以支持 母公司研发的产品和技术R44AG074840-01A。家长的资助正在展示 并验证了电阻抗心肌成像(EIM)是一种快速、无痛、廉价、非侵入性、 准确评估老年人腿部肌肉状况的方法。在父母的资助中， 我们正在通过其新设备MSCAN®与基于云的机器学习相结合来建立EIM 平台，作为获取老年人肌肉中类似MRI的定量数据的手段。在这个支持下 行政补充，我们计划从FDA获得从头开始的营销授权 MSCAN设备和支撑平台。

PROJECT SUMMARY This administrative supplement will fund development of regulatory plans in support of commercialization of products and technology developed by parent grant R44AG074840-01A. The parent grant is demonstrating and validating Electrical Impedance Myography (EIM) as a fast, painless, inexpensive, non-intrusive, accurate method for the assessment of lower extremity muscle condition in older adults. In the parent grant, we are establishing EIM, via its new device, the mScan®, in conjunction with machine learning cloud-based platform, as a means of obtaining MRI-like quantitative data in muscle of older adults. With the support of this administrative supplement, we plan to achieve de novo authorization for marketing from the FDA for the mScan device and the supporting platform.