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

项目总结

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.