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

通过电阻抗肌动描记法准确、快速地评估老年人的肌少症 - 制定监管计划补充材料

• 批准号: 10700526
• 负责人: William David Arnold
• 金额: $ 5万
• 依托单位: MYOLEX, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10700526
• 关键词: Administrative Supplement; Authorization documentation; Caring; Data; Development; Devices; Diagnostic; Elderly; Funding; Gait; Health; Impairment; Infiltration; Lower Extremity; Machine Learning; Magnetic Resonance Imaging; Marketing; Measures; Medical; Methods; Muscle; Muscle Weakness; Myography; Nurses; Painless; Physicians; Research; Techniques; Technology; Work; age-related muscle loss; authority; cloud based; commercialization; cost effective; electric impedance; improved; parent grant; physical therapist; sarcopenia; tool

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.

项目概要 该行政补充将为制定监管计划提供资金，以支持商业化 母基金 R44AG074840-01A 开发的产品和技术 母基金正在演示。 并验证电阻抗肌动描记 (EIM) 是一种快速、无痛、廉价、非侵入性、 评估老年人下肢肌肉状况的准确方法在家长的资助下， 我们正在通过其新设备 mScan® 结合基于云的机器学习来建立 EIM 平台，作为获取老年人肌肉中类似 MRI 的定量数据的手段。 行政补充，我们计划获得 FDA 的重新营销授权 mScan设备及支撑平台。