Framewise Integrated Real-Time MRI Monitoring (FIRMM) software commercialization readiness for clinical care

逐帧集成实时 MRI 监测 (FIRMM) 软件为临床护理做好商业化准备

• 批准号: 10697965
• 负责人: Ken Bruener
• 金额: $ 106.28万
• 依托单位: TURING MEDICAL TECHNOLOGIES INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697965
• 关键词: Adoption; Agreement; Anesthesia procedures; Award; Biofeedback; Brain Mapping; Breakthrough device; Catalogs; Clinical; Communication; Complex; Computer software; Data; Data Collection; Decision Making; Development; Devices; Diffusion; Engineering; Enrollment; Ensure; Epilepsy; Excision; FDA approved; Feedback; Functional Magnetic Resonance Imaging; Future; Goals; Grant; Head; Health; Healthcare Systems; Hospitals; Image; Institution; Intervention; Letters; Licensing; Magnetic Resonance Imaging; Manufacturer; Maps; Marketing; Medical; Monitor; Morphologic artifacts; Motion; Movement; Neurology; Operative Surgical Procedures; Pathway interactions; Patients; Positioning Attribute; Predisposition; Protocols documentation; Psychiatry; Questionnaires; Radiology Specialty; Randomized; Relaxation; Research; Resolution; Risk; Sales; Scanning; Scheme; Secure; Site; Source; Standardization; Suggestion; System; Tablets; Technology; Testing; Time; Translating; Vendor; Work; base; brain magnetic resonance imaging; clinical care; cohort; commercialization; commercialization readiness; cost; imaging modality; improved; neuroimaging; neuroregulation; neurosurgery; operation; price lists; programs; satisfaction; success; transmission process; treatment-resistant depression; usability; visual feedback; wasting

Project Abstract/Summary Motion related artifacts are a significant source of cost to the healthcare system. With over 12,000 MRI scanners in the U.S. and estimates that $434,000 are lost per scanner each year, motion in MRIs is costing our health care system approximately $4B yearly. Our FDA-cleared software solution Framewise Integrated Real- Time MRI Monitoring (FIRMM) mitigates data lost due to motion. However, the majority of paying customers so far are academic neuroimaging research centers; in order to ensure the commercial success of FIRMM, we need to expand the customer base to clinical institutions. The goal of this CRP application is to fill gaps in FIRMM clinical commercialization sales by partnering with Siemens and building functionality to streamline clinical use of FIRMM and FIRMM-pix. Leading hospitals have expressed enthusiasm to use FIRMM for clinical care; however, two main barriers to clinical adoption remain: a reduction in technician critical decision making and a seamless integration into existing clinical workflows. Both of these barriers can be overcome via Siemens’ Access-I, which provides an FDA approved licensing and authentication scheme to enable secure and direct operation of Siemens systems from any 3rd party vendor device. Pairing the FIRMM tablet with Siemens' Access-I module will allow for the FIRMM tablet to re-start a scan automatically when the quality is low via a direct interaction with the clinical scanner, thus saving time, easing workflows, and standardizing decision making for technicians. Integrating the FIRMM tablet with Siemens' Access-I will lead to a more seamless integration into existing workflows; thus reducing the disruption to existing complex clinical workflows. In addition, integrating the FIRMM tablet with Siemens' Access-I module will facilitate the wide-spread adoption of FIRMM(-pix) in the clinical market by obtaining widespread visibility via co-marketing with Siemens Healthineers and their catalog. Importantly, this partnership with Siemens is planned only as an initial step to establishing clinical commercialization sales. Although Siemens is the leading MRI manufacturer, GE and Philips combine with Siemens to account for almost 90% of the MRI market. The proposed activities in this CRP will form the basis of future work to establish similar partnerships with GE and Philips. Overall, this CRP is perfectly positioned to put FIRMM and its subsequent products on a pathway to long-term success.

项目摘要/摘要 与运动有关的工件是医疗系统的重要成本来源。超过12,000 MRI 美国的扫描仪，估计每年扫描仪损失了434,000美元，MRI的动议正在花费我们 医疗保健系统每年约4B美元。我们的FDA清除软件解决方案框架集成的实用 - 时间MRI监测（FIRMM）减轻由于运动而丢失的数据。但是，大多数付费客户 远是学术神经影像学中心；为了确保Firmm的商业成功，我们 需要将客户群扩展到临床机构。此CRP应用程序的目的是填补空白 FIRMM临床商业化销售与西门子合作并简化建筑功能 Firmm和Firmm-Pix的临床使用。 领先的医院表示热情使用Firmm进行临床护理；但是，两个主要 临床采用的障碍仍然存在：减少技术关键决策和无缝的障碍 集成到现有的临床工作流程中。这两个障碍都可以通过西门子的Access-I克服 它提供了FDA批准的许可和身份验证计划，以实现安全和直接操作 任何第三方供应商设备的西门子系统。将Firmm平板电脑与西门子的Access-I模块配对 将允许Firmm平板电脑通过直接相互作用自动重新启动扫描 使用临床扫描仪，从而节省了时间，缓解工作流程并标准化决策 技术人员。将Firmm平板电脑与西门子的访问集成在一起 - 我将导致更无缝的集成 现有工作流；从而减少了现有复杂临床工作流程的破坏。 此外，将Firmm平板电脑与西门子的Access-I模块集成在一起，将有助于广泛 通过与西门子共同营销，通过获得宽度的可见性来在临床市场中采用FirmM（-ppix） 卫士及其目录。重要的是，与西门子的这种合作伙伴关系仅是作为首先的一步 建立临床商业化销售。尽管西门子是领先的MRI制造商，GE和 飞利浦与西门子结合使用，占MRI市场的近90％。提出的活动 CRP将构成未来工作的基础，以与GE和Philips建立类似的合作伙伴关系。总体而言，这个CRP 完全可以使Firmm及其后续产品进入长期成功的途径。