Zeto has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-gen ONE electroencephalography (EEG) brain monitor.

Zeto已获得美国食品和药物管理局（FDA）510（k）的下一代脑电图（EEG）脑监测仪许可。

ONE is comprised of a user-friendly headset with 21 soft-tip electrodes positioned according to the 10-20 EEG system. It also has LED feedback for easy adjustments.

一个是由一个用户友好的耳机组成，该耳机具有21个软尖端电极，根据10-20 EEG系统定位。它还具有LED反馈，便于调整。

The company said it only needs minimal training to operate effectively. The portable recording devices captures patient audio and video for display and recording controls. It also offers live, artificial intelligence (AI)-enabled notifications for seizure activity.

该公司表示，它只需要很少的培训就可以有效运作。便携式录制设备捕获患者音频和视频，用于显示和录制控制。它还为癫痫发作活动提供实时的人工智能（AI）通知。

ONE streams its data to the Zeto Cloud so board-certified neurologists can interpret the data remotely. Adding to its role as a point-of-care system, it also serves as a comprehensive EEG platform. This enables workflow management, patient scheduling, and report generation.

其中一个将其数据流到Zeto云，以便董事会认证的神经科医生可以远程解释数据。除了作为护理点系统的作用外，它还可以作为一个综合的脑电图平台。这可以实现工作流管理、患者日程安排和报告生成。

'Zeto ONE is a breakthrough EEG system, revolutionizing many aspects of emergency EEG acquisition,” said Susan Herman, MD, Professor and Vice Chair of Clinical Affairs, Department of Neurology at Barrow Neurological Institute. “We know that up to 40% of brain injured emergency department and intensive care patients may experience seizures, which are often subclinical and require EEG for diagnosis.

“Zeto ONE是一个突破性的脑电图系统，彻底改变了紧急脑电图采集的许多方面，”医学博士苏珊·赫尔曼（SusanHerman）说，她是巴罗神经研究所神经病学系教授兼临床事务副主席。“我们知道，多达40%的脑损伤急诊科和重症监护患者可能会出现癫痫发作，癫痫发作通常是亚临床的，需要脑电图进行诊断。

ONE fills a gap for hospitals that lack EEG resources—provides streamlined point-of care application of full 10-20 electrodes, video and audio recording, AI triage tools, and efficient connectivity to the interpreting neurologist. This enhanced workflow ensures that EEGs have high technical quality and accurate interpretations in our most critically ill patients.'.

一个填补了缺乏脑电图资源的医院的空白，提供了完整的10-20个电极的简化护理点应用，视频和音频记录，AI分类工具，以及与口译神经科医生的有效连接。这种增强的工作流程确保脑电图在我们最危重的患者中具有高技术质量和准确的解释。”。

'Breakthrough changes arise from the cumulative effect of years of gradual improvements,” added Zeto founder and CEO Aswin Gunaseka. “ONE is a culmination of 8+ years of customer centric product development by our industrious team. As our first-generation Wrap (WR19) headset sees increasing adoption for short-term EEGs, ONE strengthens our portfolio by democratizing access to continuous EEG brain monitoring and diagnostics.

Zeto创始人兼首席执行官阿斯温·古纳塞卡（AswinGunaseka）补充道：“突破性的变化来自多年逐步改进的累积效应。”。“一个是我们勤劳的团队8年多以客户为中心的产品开发的高潮。随着我们的第一代Wrap（WR19）耳机越来越多地被短期脑电图采用，一个是通过民主化连续脑电图大脑监测和诊断来加强我们的产品组合。

We anticipate ONE to notably advance EEG monitoring in critical care, outpatient and home settings.' .

我们预计其中一项将显着提高重症监护，门诊和家庭环境中的脑电图监测。”。