REMI Platform for Remote EEG Monitoring

用于远程脑电图监测的 REMI 平台

• 批准号: 10383365
• 负责人: Mark J. Lehmkuhle
• 金额: $ 105.34万
• 依托单位: EPITEL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383365
• 关键词: Accident and Emergency department; Adhesives; Adoption; Adult; Applications Grants; Blinded; Bluetooth; Capital; Caring; Cessation of life; Child; Clinical; Clinical Trials Design; Community Hospitals; Computer software; Contracts; Costs and Benefits; Data; Development; Diagnosis; Economic Models; Electroencephalography; Emergency Situation; Emergent care; Foundations; Freedom; Goals; Health; Healthcare; Hospitals; Intellectual Property; Intensive Care Units; Investigation; Investments; Legal patent; Letters; Life; Marketing; Medical; Modeling; Monitor; Neurological emergencies; Neurologist; Neurology; Outcome; Outcomes Research; Patients; Peer Review; Phase; Physicians; Positioning Attribute; Process; Production; Randomized Clinical Trials; Randomized Controlled Trials; Readiness; Research; Resources; Risk; Running; Rural Community; Rural Hospitals; Sales; Scalp structure; Screening procedure; Secure; Seizures; Services; System; Tablets; Technology; Time; Traction; Translations; Universities; Utah; base; blind; budget impact; care costs; cloud platform; commercialization; cost; cost effective; design; health economics; improved; overtreatment; payment; pediatric emergency; prospective; remote grading; remote monitoring; screening; sensor; wireless

ABSTRACT REMI Platform for Remote EEG Monitoring The REMI EEG screening platform. The REMI app running on a medical tablet guides staff through the placement of four Epilog sensors. Epilog transmits EEG through Bluetooth to the app which then relays the data to a cloud server running Persyst EEG reviewing software. An epileptologist logs on to Persyst Mobile to remotely review Epilog EEG in real time as a 10-channel “longitudinal-transverse” montage in Persyst. PROBLEM There is a clear need for discrete, wearable EEG that can be deployed by non-EEG professionals in an emergent setting, especially in community and rural hospitals that lack an EEG service. Rapid neuro screening with EEG is critical for situations when patients are at risk of under-treatment if they are having undetected subclinical or non-convulsive seizures, over-treatment if EEG is normal, and delayed treatment if they are transported to a tertiary hospital for diagnosis. WEARABLE SOLUTION Epitel has developed Epilog, a wireless wearable EEG sensor capable of transmitting EEG to a recording, display, and review platform called REMI (Remote EEG Monitoring). Developed through R43/R44, REMI synchronizes four Epilog sensors placed by hospital Emergency Department (ED) staff within minutes of patient arrival who are suspect of seizures, prior to initial treatment. REMI securely transmits the data Epilog sensors use a one-piece conductive and adhesive to its cloud server where Persyst® software ‘sticker’ that attaches the sensor to the scalp below hairline. processes the EEG in the real time for live remote review by an epileptologist using Pesyst Mobile. As the final milestone in R44, Epitel cleared the REMI platform with FDA (K203827) for use as a remote EEG screening tool for emergent care in EDs and intensive care units, specifically targeting community and rural hospitals that do not have access to neurology or EEG. REMI enables epileptologists to remotely direct time-sensitive treatment more accurately and faster in hospitals that lack neurology or the capability to provide emergency EEG services. COMMERCIALIZATION READINESS PILOT (CRP) Gaining market clearance through FDA is simply the first step toward commercialization. We have identified 5 post-FDA development activities designed for translation. 1. Demonstrate Clinical Utility through a multi-center, prospective, blinded, randomized clinical trial in children and adults 2. Health Economics and Outcomes Research 3. Intellectual Property Strategy assistance 4. Manufacturing Optimization 5. Go-to-Market Technical Assistance The value of this CRP for Epitel is evidence for clinical utility, health economics modeling, market access, and manufacturing optimization. The technical assistance provided through this CRP will de-risk our technology to make the REMI platform attractive to venture capital investment prior to full commercialization.

抽象的 远程脑电图监视的REMI平台 REMI EEG筛选平台。在医疗平板电脑上运行的雷米应用程序通过 放置四个Epilog传感器。 Epilog通过蓝牙将脑电图传输到该应用 数据到运行persyst脑电图审查软件的云服务器。癫痫学家登录到Persyst Mobile 远程回顾Epilog EEG，作为10通道中的“纵向横向”单声道。 问题显然需要由非EEG专业人员部署的离散，可穿戴的脑电图 在紧急情况下，尤其是在社区和缺乏脑电图服务的粗糙医院。快速神经 用脑电图筛查对于患者患者患有不足的情况至关重要，如果 未检测到的亚临床或非偏置性癫痫 他们被送往三级医院进行诊断。 可穿戴解决方案 Epitel开发了Epilog，一种无线 可穿戴的EEG传感器能够传输 脑记录到录音，显示和审查 称为remi的平台（远程脑电图 监视）。通过R43/R44开发 雷米同步四个Epilog传感器 由医院急诊室放置 （ed）患者到达后的几分钟内工作人员 在首次之前犯了怀疑癫痫发作的人 治疗。 remi安全地传输数据EPILOG传感器使用单件导电和粘合剂 在其云服务器上，将传感器附加到发际线下方的头皮上的Persyst®软件“贴纸”。 实时处理脑电图 癫痫学家使用PESYST手机进行远程审查。作为R44的最后一个里程碑，Epitel清除了Remi 使用FDA（K203827）的平台用作远程脑电图筛选工具，用于ED和密集的紧急护理 护理单位，特别针对无法获得神经病学或脑电图的社区和粗糙的医院。 REMI使癫痫学家能够更准确地远程直接对时间敏感的治疗 缺乏神经病学或提供紧急脑电服务的能力。 商业化准备飞行员（CRP）通过FDA获得市场许可只是第一个 迈向商业化。我们已经确定了5项用于翻译的FDA后开发活动。 1。通过多中心，前瞻性，盲目的随机临床试验证明临床实用性 在儿童和成人中 2。卫生经济学和结果研究 3。知识产权战略援助 4。制造优化 5。上市的技术援助 该CRP对epitel的价值是临床公用事业，健康经济学建模，市场获取和 制造优化。通过此CRP提供的技术援助将使我们的技术危险到 在全面商业化之前，使雷米平台对风险投资具有吸引力。