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 运动相关伪影是医疗保健系统的重要成本来源。超过12，000个MRI 扫描仪在美国，估计每台扫描仪每年损失434，000美元，MRI中的运动正在花费我们的 医疗保健系统每年约40亿美元。我们的FDA批准的软件解决方案Framewise Integrated真实的- 时间MRI监测（FIRMM）可减少因运动而丢失的数据。然而，大多数付费客户 远是学术神经影像研究中心;为了确保FIRMM的商业成功，我们 需要将客户群扩大到临床机构。此CRP应用程序的目标是填补 FIRMM通过与西门子合作进行临床商业化销售，并构建功能以简化 FIRMM和FIRMM-pix的临床应用。 领先的医院表示了将FIRMM用于临床护理的热情;然而， 临床采用的障碍仍然存在：技术人员关键决策的减少和无缝的 整合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SIEMENS-I克服， 它提供了FDA批准的许可和认证方案， 来自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E-I模块配对 将允许FIRMM平板电脑在质量较低时通过直接交互自动重新启动扫描 使用临床扫描仪，从而节省时间，简化工作流程，并标准化决策， 专业人将FIRMM平板电脑与西门子的EQU-I集成， 现有工作流程;从而减少对现有复杂临床工作流程的干扰。 此外，将FIRMM平板电脑与西门子的E-I模块集成， 通过与西门子的联合营销获得广泛的知名度，在临床市场采用FIRMM（-pix） 保健师和他们的目录重要的是，与西门子的合作只是计划的第一步， 建立临床商业化销售。虽然西门子是领先的MRI制造商，但GE和 飞利浦联合收割机和西门子占据了近90%的MRI市场。在这方面拟议的活动 CRP将成为今后与通用电气和飞利浦建立类似伙伴关系的工作基础。总的来说， 完全有能力使FIRMM及其后续产品走上长期成功的道路。