Digital Itap Supplement

数字 Itap 补充

• 批准号: 10654931
• 负责人: BRYAN O BUCHHOLZ
• 金额: $ 124.66万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10654931
• 关键词: Address; Boston; Businesses; COVID-19 detection; COVID-19 diagnostic; COVID-19 pandemic; Characteristics; Clinical; Clinical Research; Development; Device or Instrument Development; Engineering; General Hospitals; Goals; Healthcare; Heart Diseases; Hematological Disease; Incubators; Lung diseases; Massachusetts; Medical; Medical Device; National Heart, Lung, and Blood Institute; National Institute of Biomedical Imaging and Bioengineering; Performance; Point of Care Technology; Population; Process; Research; Resources; Site; Sleep Disorders; Technology; Testing; Universities; Work; commercialization; digital; in-vitro diagnostics; industry partner; medical schools; new technology; programs; usability

Abstract The goal of this initiative is to fast-track carefully selected clinical studies that can help address the urgent healthcare issues created by the COVID-19 pandemic. The extent and urgency of the situation requires an aggressive approach to accelerate the delivery of solutions to address current needs. The proposed approach augments the strong technical, clinical and commercialization expertise of CAPCaT to get needed solutions into practice within weeks to months. This supplement will use a digital, site-less study approach to test the clinical performance of new in vitro diagnostics for SARS-CoV-2. The Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Diseases is an offshoot of a highly successful medical product incubator, the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell and Medical School campuses. The founding goal of M2D2 was to accelerate the development of medical devices, combining the engineering and business expertise of UMass Lowell (UML) with the clinical expertise of UMass Medical School (UMMS) in Worcester. CAPCaT, along with M2D2, has a network of industry partners and funders to support the development and commercialization of promising technologies. Among our industry partners are Johnson & Johnson, Boston Scientific, Amgen, and Hologic. CAPCaT is one of four Point of Care Technology Research Network (POCTRN) Centers (Emory/GA Tech, Northwestern, and Johns Hopkins University house the others). CAPCaT has worked with the other POCTRN Centers and its Coordinating Center (CIMIT-Mass General Hospital) and our scientific and program officers at NHLBI and NIBIB to review the situation and to understand unmet needs and resources accessible by the network that can make a difference.

抽象的 该倡议的目的是快速进行精心选择的临床研究，以帮助解决 COVID-19大流行创造的紧急医疗保健问题。的程度和紧迫性 情况需要一种积极的方法来加速解决方案以解决 当前需求。拟议的方法增加了强大的技术，临床和 CAPCAT的商业化专业知识，以在数周内将所需的解决方案付诸实践 月份。该补充剂将使用数字，无网站的研究方法来测试临床 SARS-COV-2的新体外诊断性能。前进的中心 心脏，肺，血液和睡眠疾病的护理技术（CAPCAT）是 非常成功的医疗产品孵化器，马萨诸塞州医疗设备开发 马萨诸塞大学洛厄尔大学和医学院校园的中心（M2D2）。这 M2D2的创建目标是加速医疗设备的开发，结合 UMass Lowell（UML）的工程和业务专业知识具有UMass的临床专业知识 伍斯特的医学院（UMMS）。 CAPCAT与M2D2一起拥有一个行业网络 合作伙伴和资助者支持有前途的发展和商业化 技术。我们的行业合作伙伴包括约翰逊和约翰逊，波士顿科学，安进 和全息。 CAPCAT是四个护理技术研究网络（POCTRN）之一 中心（Emory/GA Tech，Northwestern和Johns Hopkins University House其他）。 Capcat曾与其他Poctrn中心及其协调中心合作（Cimit-Mass 综合医院）以及我们在NHLBI和NIBIB的科学和计划官员审查 情况并了解网络可以访问的未满足的需求和资源 有所作为。