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中文摘要
翻译
NICHD与美国国家生物医学成像和生物工程研究所(NIBIB)以及美国国立卫生研究院主任办公室合作,旨在利用RADx Tech项目的创新漏斗设计——NIBIB曾使用该设计来加速COVID-19检测技术的开发、商业化和实施——来加速诊断设备、可穿戴设备、或其他遥感技术,这些技术可以减少产后第一年(即从分娩之日或妊娠结束之日起)居住在产科护理沙漠的个人的SMM/MM。创新漏斗方法使用阶段性的、里程碑式的奖励支付来压缩传统的技术开发时间表。这是通过同时雇用专家团队来解决科学/技术、法规、临床和商业化需求来实现的,以通过无缝管道验证、降低风险、扩大规模、制造和部署新的测试。
英文摘要
NICHD, in partnership with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the NIH Office of the Director, aims to leverage the RADx Tech program’s innovation funnel design—which was used by NIBIB to speed the development, commercialization and implementation of COVID-19 testing technologies—to accelerate the development of diagnostic devices, wearables, or other remote sensing technologies that can reduce SMM/MM for individuals residing in maternity care deserts during the first year of the postpartum period (namely, from day of delivery or end of pregnancy). The innovation funnel approach uses stage-gated, milestone-based award payments to compress the customary technology development timeline. this is accomplished by employing, in parallel, expert teams to address scientific/technical, regulatory, clinical, and commercialization requirements to validate, de-risk, scale up, manufacture, and deploy novel tests through seamless pipeline. Successful outputs from this Challenge may include technologies such as wearable devices, smartphone-enabled diagnostic tools, integrated sensor technologies, and diagnostic devices or tests for use at-home or at the point-of-care (POC). Solutions generated by innovators shall allow continuity of monitoring when access to care providers is limited and extend diagnostic and monitoring capabilities to support timely return to maternity care when necessary. Priority conditions for prediction, detection, diagnosis, and monitoring during the postpartum period may include cardiovascular diseases (such as cardiomyopathies), hemorrhage, sepsis, and mental health conditions (such as postpartum depression), which are recognized as associated with high rates of severe morbidity and mortality during the first year after delivery or end of pregnancy.
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RADX Independent Test Assessment Program for MPOX Lesion Panel - Commercialization Center
  • 批准号:
    10941137
  • 项目类别:
  • 资助金额:
    $65.98万
  • 财政年份:
    2023
  • 负责人:
    MARK MARINO
  • 依托单位:
NCE FOR COMMERCIALIZATION CENTER TASK ORDER FOR CANCER SCREENING RESEARCH NETWORK
  • 批准号:
    10976181
  • 项目类别:
  • 资助金额:
    $52.85万
  • 财政年份:
    2023
  • 负责人:
    MARK MARINO
  • 依托单位:
NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING (NIBIB) INNOVATION FUNNEL FOR HIV/AIDS - COMMERCIALIZATION CENTER
  • 批准号:
    10708392
  • 项目类别:
  • 资助金额:
    $30.68万
  • 财政年份:
    2022
  • 负责人:
    MARK MARINO
  • 依托单位:
SUPPLEMENTAL FUNDS FOR RADX INDEPENDENT TEST ASSESSMENT PROGRAM FOR HEPATITIS C VIRUS - COMMERCIALIZATION CENTER
  • 批准号:
    10934771
  • 项目类别:
  • 资助金额:
    $85.0万
  • 财政年份:
    2022
  • 负责人:
    MARK MARINO
  • 依托单位:
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