SALT LAKE CITY--(BUSINESS WIRE)--Epitel, a leader in AI technologies for patient-focused brain health solutions, announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearances for two new innovative technologies: REMI™ Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz™ AI For Event Detection.

盐湖城--（商业新闻短讯）--Epitel是以患者为中心的大脑健康解决方案人工智能技术的领导者，今天宣布它获得了美国食品和药物管理局（FDA）510（k）的两项新创新技术的许可：用于门诊（家中）使用的REMI™远程脑电图监测系统和用于事件检测的REMI Vigilenz™AI。

REMI for Ambulatory use allows EEG recording in outpatient and home environments for an extended duration, while REMI Vigilenz AI for Event Detection analyzes and marks REMI EEG records for potential electrographic seizures to assist with ease and accuracy of interpretation..

非卧床使用的REMI允许在门诊和家庭环境中长时间记录脑电图，而用于事件检测的REMI Vigilenz AI则分析并标记REMI脑电图记录的潜在电图癫痫发作，以帮助轻松准确地解释。。

“Existing EEG monitoring systems have been cumbersome and restrictive for patients, and technical requirements and limitations have impeded providers' ability to administer, record, and interpret EEG. REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions,” said Mark Lehmkuhle, PhD, Chief Executive Officer and Co-Founder of Epitel.

Epitel首席执行官兼联合创始人Mark Lehmkuhle博士说：“现有的脑电图监测系统对患者来说既麻烦又有限制，技术要求和局限性阻碍了提供者管理、记录和解释脑电图的能力。用于事件检测的REMI Ambulatory和REMI Vigilenz AI将帮助患者和提供者做出更明智的治疗决策。”。

“We are excited about how these two advances will shift the paradigm of brain health monitoring.”.

“我们对这两项进展将如何改变大脑健康监测的范式感到兴奋。”。

Current outpatient and ambulatory EEG monitoring is often uncomfortable and inconvenient. Patients are unable to go about their daily activities, including something as simple as moving about their own house, due to the burdens of a fully wired system, while some patients may experience infrequent seizures that standard 72-hour ambulatory EEG studies may miss or be unable to classify seizures adequately.1 REMI Ambulatory allows for an extended EEG in the comfort of one's home while going about daily activities.

目前的门诊和动态脑电图监测通常不舒服和不方便。由于全有线系统的负担，患者无法进行日常活动，包括像在自己家里走动这样简单的事情，而一些患者可能会经历罕见的癫痫发作，标准的72小时动态脑电图研究可能会错过或无法对癫痫发作进行充分分类。1 REMI动态脑电图允许在日常活动中在家中舒适地进行扩展脑电图。

REMI Ambulatory leverages the same REMI Sensors used in REMI for Healthcare Facility Use and adds a mobile computing platform that allows patients and caregivers to mark when they’ve experienced an event or suspected event..

REMI Ambulatory利用REMI中用于医疗保健设施的相同REMI传感器，并添加了一个移动计算平台，允许患者和护理人员在经历事件或疑似事件时进行标记。。

“Patients with infrequent seizures may go on for years without definitive diagnosis and characterization of their seizure events, which may result in either inappropriate medications or use of medications when not necessary. Most significantly, some patients may not be started on medications because the events were not thought to be seizures,” said Jong Woo Lee, MD, PhD, associate professor of neurology at Harvard Medical School..

哈佛医学院神经病学副教授Jong Woo Lee博士说：“罕见癫痫发作的患者可能会持续数年，而没有明确的诊断和癫痫发作事件的特征，这可能会导致不适当的药物治疗或在不必要时使用药物。最重要的是，一些患者可能不会开始服用药物，因为这些事件被认为不是癫痫发作。”。。

Extended-duration ambulatory EEGs can often amass weeks’ or months' worth of the data needed to detect and assess seizures accurately. This aggregation of data can be time-consuming for epileptologists to interpret and may cause lengthy delays for patients and providers trying to make informed treatment decisions.

延长持续时间的动态脑电图通常可以积累数周或数月的数据，以准确检测和评估癫痫发作。这种数据汇总对于癫痫病学家来说可能是耗时的，并且可能会导致患者和提供者试图做出明智的治疗决策的长时间延迟。

REMI Vigilenz AI for Event Detection leverages state-of-the-art proprietary machine learning to identify and annotate potential seizure events in REMI EEG records. The platform categorizes seizure-like events with four levels of confidence, improving ease and speed of interpretation. The FDA also cleared REMI Vigilenz AI for Event Detection with a Predetermined Change Control Plan (PCCP), a new program to help AI/ML-enabled devices to manage change.

用于事件检测的REMI Vigilenz AI利用最先进的专有机器学习来识别和注释REMI EEG记录中的潜在癫痫发作事件。该平台将癫痫样事件分为四个置信水平，提高了解释的容易性和速度。FDA还通过预先确定的变更控制计划（PCCP）批准了REMI Vigilenz AI用于事件检测，这是一个新程序，可帮助支持AI/ML的设备管理变更。

Under this Authorized PCCP, Epitel expects to train REMI Vigilenz AI further over time to improve its performance at detecting potential seizures, aiding physicians in providing better clinical care..

根据这一授权的PCCP，Epitel预计将随着时间的推移进一步培训REMI Vigilenz AI，以提高其检测潜在癫痫发作的性能，帮助医生提供更好的临床护理。。

REMI Ambulatory and REMI Vigilienz AI For Event Detection will be available through select practices later this year. Clinicians and practices interested in partnering with Epitel can request additional information via www.epitel.com. Epitel is venture-backed by ​​Catalyst Health Ventures (CHV), Genoa Ventures, Dexcom, OSF Ventures, Wavemaker 360, MedMountain Ventures and Salt Lake City Angels..

用于事件检测的REMI Ambulatory和REMI Vigilienz AI将于今年晚些时候通过精选实践提供。有兴趣与Epitel合作的临床医生和实践机构可以通过www.Epitel.com请求更多信息。Epitel由​​Catalyst Health Ventures（CHV）、热那亚Ventures、Dexcom、OSF Ventures、Wavemaker 360、Medmounting Ventures和盐湖城天使。。

REMI Remote EEG Monitoring Indications For Use

REMI远程脑电图监测指示使用

The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days..

REMI远程脑电图监测系统适用于保证近实时和/或远程脑电图的医疗保健环境，以及保证远程脑电图的门诊环境。REMI使用一次性、单病人、一次性、可穿戴传感器，用于放大、捕获和无线传输大脑的单个电活动通道，持续时间长达30天。。

The REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software..

REMI系统使用在合格的商业现成移动计算平台上运行的REMI移动软件应用程序。REMI Mobile向训练有素的医疗专业人员显示用户设置信息，并向医疗专业人员和门诊用户提供通知。REMI Mobile接收连接的REMI传感器的数据并将其传输到安全的REMI云，在那里存储数据并准备在合格的脑电图查看软件上进行审查。。

REMI does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).

REMI不会对受试者的病情做出任何诊断结论，而是用作生理信号监测器。REMI系统适用于成人和儿科患者（6岁以上）。

REMI Vigilenz AI For Event Detection Indications For Use

REMI Vigilenz AI用于事件检测指示

REMI Vigilenz AI For Event Detection is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI Vigilenz AI For Event Detection is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information..

REMI Vigilenz AI用于事件检测，用于分析REMI远程脑电图监测系统脑电图（EEG）记录。REMI Vigilenz AI用于事件检测，旨在供有资格分析和解释脑电图的医生使用，他们将在使用信息时进行专业判断。。

As an aide to the qualified physician’s REMI EEG review, REMI Vigilenz AI For Event Detection marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI Vigilenz AI For Event Detection is indicated for use with adult and pediatric patients (6+ years)..

作为合格医师REMI EEG审查的助手，用于事件检测的REMI Vigilenz AI标记了先前获得的REMI EEG部分，这些部分可能对应于感兴趣的神经事件，表明潜在的电图癫痫发作持续至少10秒。用于事件检测的REMI Vigilenz AI适用于成人和儿科患者（6岁以上）。。

REMI Vigilenz AI For Event Detection does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient's condition to the user.

用于事件检测的REMI Vigilenz AI不会实时标记REMI EEG记录，也不会向用户提供有关患者病情的任何诊断结论。

About Epitel, Inc.

关于Epitel，Inc。

Epitel™ is a digital health company modernizing brain health solutions to improve seizure monitoring and detection. By leveraging a proprietary cloud-based wearable sensor system and other innovative AI technologies, Epitel is empowering better treatment decisions by making EEG readily deployable and accessible.

Epitel™是一家数字健康公司，对大脑健康解决方案进行现代化改造，以改善癫痫发作的监测和检测。通过利用专有的基于云的可穿戴传感器系统和其他创新的人工智能技术，Epitel通过使EEG易于部署和访问来实现更好的治疗决策。