FDA授予Epitel无线脑电图系统扩展的510(k)许可-动脉网

FDA grants expanded 510(k) clearance for Epitel’s wireless EEG system

Medical Device Network 等信源发布 2025-04-01 07:55

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The system is intended for neurological monitoring in infants and pediatric patients aged one year and above. Credit: Saylakham / Shutterstock.

该系统用于一岁及以上婴幼儿和儿科患者的神经监测。来源：Saylakham / Shutterstock。

The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants and paediatric patients aged one year and above.

美国食品药品监督管理局 (FDA) 已授予 Epitel 的 REMI 无线脑电图 (EEG) 系统扩大 510(k) 许可，用于一岁及以上婴幼儿和儿科患者的神经监测。

According to the company, the system’s design offers a “comfortable” experience, averting children from wire pulling or electrode displacing, which could compromise the integrity of the data.

据该公司称，该系统的设计提供了“舒适”的体验，避免儿童拉扯电线或电极移位，从而影响数据的完整性。

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Additionally, the system’s setup and extended monitoring claims to offer wireless brain health examination at home or hospital with no constraints associated with a tethered system.

此外，该系统的设置和扩展监控声称可以在家中或医院进行无线大脑健康检查，且不受有线系统的限制。

This is the fifth 510(k) clearance for the Epitel’s REMI portfolio, with the first clearance obtained in March 2021.

这是Epitel的REMI产品组合获得的第五次510(k)许可，其首次许可于2021年3月获得。

The REMI System is suitable for healthcare settings requiring near real-time or remote EEG monitoring and for ambulatory settings that require remote monitoring.

REMI系统适用于需要接近实时或远程脑电图监测的医疗环境，以及需要远程监测的门诊环境。

It uses disposable, single-use wearable sensors to capture and wirelessly transmit brain activity for up to 30 days.

它使用一次性、单次使用的可穿戴传感器来捕捉并无线传输大脑活动，最长可达30天。

The accompanying REMI Mobile application displays setup information for medical professionals and delivers notifications to medical staff and ambulatory users.

随附的REMI移动应用程序显示医疗专业人员的设置信息，并向医务人员和门诊用户发送通知。

Data from the connected REMI Sensors is transmitted to the REMI Cloud for storage and review using qualified EEG viewing software.

来自连接的REMI传感器的数据会传输到REMI云端，以便使用合格的EEG查看软件进行存储和审查。

The REMI System does not provide diagnostic conclusions about the patient’s condition, and it is intended as a monitor of physiological signals for adult and paediatric subjects over one-year-old, as stated by the company.

REMI系统并不提供关于患者病情的诊断结论，根据公司声明，它旨在监测一岁以上成人和儿童受试者的生理信号。

Epitel CEO Steve Pacelli said: “Epitel continues to make EEG monitoring accessible and deployable for all communities. This new clearance reflects our commitment to improving brain health across all age groups, demographics, and geographies, ensuring that even the youngest patients receive timely and accurate care.”.

Epitel首席执行官史蒂夫·帕切利表示：“Epitel继续让所有社区都能获得并部署脑电图监测。这一新的许可反映了我们致力于改善所有年龄组、人口统计和地理区域的脑健康，确保最年轻的患者也能得到及时且准确的护理。”

In April 2024, the company

2024年4月，该公司

obtained 510(k) clearance

获得了510(k)许可

for its REMI Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz AI For Event Detection.

针对其用于院外（居家）使用的REMI远程脑电图监测系统和REMI Vigilenz人工智能事件检测系统。

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