EN
登录

医疗器械研发商SmartCardia用于门诊心脏遥测的心电图贴片获FDA批准

FDA clears outpatient cardiac telemetry for SmartCardia ECG patch

MASSDEVICE 等信源发布 2024-11-13 00:09

可切换为仅中文


SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG platform.

SmartCardia今天宣布,其ECG平台的移动门诊心脏遥测(OCT/MCT)已获得FDA批准。

The clearance comes for the company’s seven-lead live ECG montoring patch and cloud platform. SmartCardia designed its easy-to-wear, cable-free, waterproof patch for up to 14 days of continuous monitoring. The Lausanne, Switzerland-based company already has FDA clearance for extended Holter, event and Holter monitoring..

该许可是针对该公司的七导联实时心电图监测补丁和云平台。SmartCardia设计了一种易于佩戴、无电缆、防水的贴片,可连续监测14天。这家总部位于瑞士洛桑的公司已经获得FDA批准,可以进行延长动态心电图、事件和动态心电图监测。。

With the latest approval, the system now offers remote live monitoring for ECG and immediate clinician notifications for important arrhythmias.

经最新批准,该系统现在为心电图提供远程实时监测,并为重要心律失常提供即时临床医生通知。

The seven ECG leads stream live to the cloud, with ECG immediately available. The prorprietary cloud platform analyzes the ECG live to provide outpatient telemetry notifications and full disclosure ECG analysis. According to SmartCardia, it also features a real-time view of the patient’s ECG and can deliver visual and audio alarms..

七个ECG将stream live连接到云端,并立即提供ECG。prorprietary云平台实时分析心电图,以提供门诊遥测通知和全面披露心电图分析。据SmartCardia介绍,它还可以实时查看患者的心电图,并可以提供视觉和音频警报。。

All ECG data transmits live, with automated analysis applied continuously across the entire signal, The full-disclosure analysis enables highly accurate arrhythmia detection. Meanwhile, the cloud platform’s intuitive navigation allows clinicians to easily review and analyze ECG data at any moment.

所有ECG数据实时传输,通过在整个信号中连续应用自动分析,完全公开的分析可以实现高度准确的心律失常检测。同时,云平台的直观导航使临床医生可以随时轻松查看和分析心电图数据。

“Many products available on the market do not have explicit FDA clearance for outpatient cardiac telemetry. Our patch and cloud platform are designed from the ground up to meet stringent outpatient telemetry standards, and this clearance validates our commitment and efforts. With an end-to-end patch to cloud, our solution provides accurate and on time detection of arrhythmia events,” said Adam Kirchgessner, SmartCardia’s U.S.

SmartCardia美国分公司的Adam Kirchgessner说:“市场上的许多产品都没有明确的FDA批准用于门诊心脏遥测。我们的补丁和云平台从头开始设计,以满足严格的门诊遥测标准,这一批准验证了我们的承诺和努力。通过端到端的云补丁,我们的解决方案可以准确及时地检测心律失常事件。”。