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EMEATelehealthPatient-friendly real-time remote monitoring system receives FDA clearanceFDA clearance opens US door for European RPM system

EMEATelehealthPatient-friendly实时远程监控系统获得FDA许可FDA许可为欧洲RPM系统打开美国大门

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April 04, 202409:12 AM

202409年4月4日上午12:12

Corsano Health Patient-friendly real-time remote monitoring system

Corsano Health患者友好实时远程监控系统

Image: Corsano Health

图片：科萨诺健康

Current solutions for remote health monitoring can be seen as invasive by patients and mostly do single variant intermittent tracking. FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time.

目前用于远程健康监测的解决方案被患者视为具有侵入性，并且大多进行单变量间歇性跟踪。FDA的批准首次将欧洲最先进的实时连续远程监控系统之一带入美国市场。

A patient-friendly multi-sensor bracelet which helps to address some of the key challenges around the adoption of remote patient monitoring systems (RPM) has been given clearance by the United States Food and Drug Administration (FDA).

美国食品和药物管理局（FDA）批准了一种对患者友好的多传感器手镯，该手镯有助于解决采用远程患者监测系统（RPM）所面临的一些关键挑战。

Corsano Health’s CardioWatch System is an advanced real-time monitoring system, which consists of a bracelet worn by an adult patient (at least 22 years old), a web-based browser, and a mobile app that can operate in either patient or healthcare professional (HCP) mode.

Corsano Health的CardioWatch系统是一种先进的实时监测系统，由成年患者（至少22岁）佩戴的手镯，基于网络的浏览器和可在患者或医疗保健专业（HCP）模式下运行的移动应用程序组成。

The system collects continuous vital signs data and makes it available to patients, clinicians, healthcare providers and developers for screening, diagnosis, treatment and care, and clinical research applications.

该系统收集连续的生命体征数据，并将其提供给患者，临床医生，医疗保健提供者和开发人员，用于筛查，诊断，治疗和护理以及临床研究应用。

Vital signs that can be monitored include Pulse Rate, Saturation (SpO2), Respiration Rate, Temperature, Activity, Spiro and Lung Function, Blood Pressure, and Weight. Encrypted data is transmitted from the system to a secure health cloud, where it is stored and made available for further analysis, including for AI and ML applications development..

可以监测的生命体征包括脉搏率、饱和度（SpO2）、呼吸频率、体温、活动、呼吸和肺功能、血压和体重。加密数据从系统传输到安全的健康云，在那里存储并可用于进一步分析，包括用于AI和ML应用程序开发。。

European pedigree

欧洲血统书

FDA clearance is significant for a system which is already CE-MDR medically certified in Europe. It has played a role in more than 100 clinical trials and research projects, mainly Europe-focused, including the development of cardiovascular, oncology and stress therapies. The results of these trials have been published in medical publications such as The Lancet, Nature, and the European Heart Journal..

FDA的批准对于已经在欧洲获得CE-MDR医学认证的系统具有重要意义。它在100多个临床试验和研究项目中发挥了作用，主要集中在欧洲，包括心血管，肿瘤学和压力疗法的开发。这些试验的结果已发表在医学出版物上，如《柳叶刀》、《自然》和《欧洲心脏杂志》。。

'This achievement is a major milestone for Corsano Health in its mission to provide continuous patient monitoring, anytime, anywhere,' said CEO Dr Peter Stas.

首席执行官彼得·斯塔斯（PeterStas）博士说：“这一成就是科萨诺健康（Corsano Health）在其随时随地提供持续患者监测的使命中的一个重要里程碑。”。

“We take pride in delivering a proven and reliable digital health system that accelerates clinical trials and generates unparalleled insights to develop life-saving therapies faster.”

“我们为提供一个经过验证和可靠的数字健康系统而感到自豪，该系统可以加速临床试验，并产生无与伦比的见解，以更快地开发挽救生命的疗法。”

According to analyst Straits Research, RPM and the increasing prevalence of chronic conditions are the main drivers of a global patient monitoring market which is growing by 7.3% annually, and will be worth $91.04 billion by 2031. The analyst suggests that RPM’s capacity to lower costs and enhance outcomes is “transforming” healthcare provision in the US..

根据Straits Research的分析，RPM和慢性病患病率的增加是全球患者监测市场的主要驱动因素，该市场每年以7.3%的速度增长，到2031年将达到910.4亿美元。该分析师表示，RPM降低成本和提高成果的能力正在“改变”美国的医疗保健服务。。

Reduced overall healthcare costs, fewer hospital readmissions, improved patient mobility, and insights that can be captured in real-time to provide a more streamlined patient experience are also widely seen as potential benefits of RPM implementation.

降低总体医疗保健成本，减少再入院，改善患者移动性，以及可以实时捕获以提供更简化的患者体验的见解，也被广泛视为RPM实施的潜在好处。

Meeting the integration challenge

迎接集成挑战

However, integration remains an important challenge for developers and digital health leaders as they seek to enable and realise those benefits. The Corsano CardioWatch System includes an API and Software Development Kit (SDK), which allows providers of RPM platforms and researchers to build interfaces between the device and their own systems..

然而，对于开发人员和数字健康领导者来说，集成仍然是一个重要的挑战，因为他们寻求实现这些好处。Corsano CardioWatch系统包括一个API和软件开发工具包（SDK），它允许RPM平台的提供商和研究人员在设备和他们自己的系统之间构建接口。。

The system is also integrated with third-party devices for displaying and monitoring physiological signs including spot monitoring of non-invasive blood pressure (NIBP), lung function and spirometry, weight, and continuous monitoring of axillary temperature.

该系统还与第三方设备集成，用于显示和监测生理体征，包括无创血压（NIBP）的现场监测，肺功能和肺活量测定，体重以及腋窝温度的连续监测。

Other challenges for RPM adoption include patient participation in the system and adherence to its use, and the burden of data management and interpretation which new systems can impose on healthcare professionals.

RPM采用的其他挑战包括患者参与系统并遵守其使用，以及新系统可能给医疗保健专业人员带来的数据管理和解释负担。

As a highly automated, non-intrusive solution, the CardioWatch System can assist with the creation of personalised treatment plans which help patients to feel more motivated to participate in their own care, improving outcomes and providing a better patient experience.

作为一种高度自动化的非侵入性解决方案，CardioWatch系统可以帮助创建个性化治疗计划，帮助患者更有动力参与自己的护理，改善结果并提供更好的患者体验。

The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or at home by trained healthcare professionals. For them, the system enables in-house monitoring – for example, notifying them when physiological data falls outside selected parameters while freeing them from manual monitoring tasks. .

该手镯适用于医院或专业护理机构等专业医疗机构，或由受过训练的医疗保健专业人员在家使用。对于他们来说，该系统可以实现内部监测-例如，当生理数据超出选定参数时通知他们，同时将他们从手动监测任务中解放出来。。

Find out more at Corsano Health.

在Corsano Health了解更多信息。

Topics: Telehealth

主题：远程医疗

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更多地区新闻

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Current solutions for remote health monitoring can be seen as invasive by patients and mostly do single variant intermittent tracking. FDA clearance brings one of Europe’s most advanced real-time continuous remote monitoring systems to the US market for the first time.

目前用于远程健康监测的解决方案被患者视为具有侵入性，并且大多进行单变量间歇性跟踪。FDA的批准首次将欧洲最先进的实时连续远程监控系统之一带入美国市场。

A patient-friendly multi-sensor bracelet which helps to address some of the key challenges around the adoption of remote patient monitoring systems (RPM) has been given clearance by the United States Food and Drug Administration (FDA).

美国食品和药物管理局（FDA）批准了一种对患者友好的多传感器手镯，该手镯有助于解决采用远程患者监测系统（RPM）所面临的一些关键挑战。

Corsano Health’s CardioWatch System is an advanced real-time monitoring system, which consists of a bracelet worn by an adult patient (at least 22 years old), a web-based browser, and a mobile app that can operate in either patient or healthcare professional (HCP) mode.

Corsano Health的CardioWatch系统是一种先进的实时监测系统，由成年患者（至少22岁）佩戴的手镯，基于网络的浏览器和可在患者或医疗保健专业（HCP）模式下运行的移动应用程序组成。

The system collects continuous vital signs data and makes it available to patients, clinicians, healthcare providers and developers for screening, diagnosis, treatment and care, and clinical research applications.

该系统收集连续的生命体征数据，并将其提供给患者，临床医生，医疗保健提供者和开发人员，用于筛查，诊断，治疗和护理以及临床研究应用。

Vital signs that can be monitored include Pulse Rate, Saturation (SpO2), Respiration Rate, Temperature, Activity, Spiro and Lung Function, Blood Pressure, and Weight. Encrypted data is transmitted from the system to a secure health cloud, where it is stored and made available for further analysis, including for AI and ML applications development..

可以监测的生命体征包括脉搏率、饱和度（SpO2）、呼吸频率、体温、活动、呼吸和肺功能、血压和体重。加密数据从系统传输到安全的健康云，在那里存储并可用于进一步分析，包括用于AI和ML应用程序开发。。

European pedigree

欧洲血统书

FDA clearance is significant for a system which is already CE-MDR medically certified in Europe. It has played a role in more than 100 clinical trials and research projects, mainly Europe-focused, including the development of cardiovascular, oncology and stress therapies. The results of these trials have been published in medical publications such as The Lancet, Nature, and the European Heart Journal..

FDA的批准对于已经在欧洲获得CE-MDR医学认证的系统具有重要意义。它在100多个临床试验和研究项目中发挥了作用，主要集中在欧洲，包括心血管，肿瘤学和压力疗法的开发。这些试验的结果已发表在医学出版物上，如《柳叶刀》、《自然》和《欧洲心脏杂志》。。

'This achievement is a major milestone for Corsano Health in its mission to provide continuous patient monitoring, anytime, anywhere,' said CEO Dr Peter Stas.

首席执行官彼得·斯塔斯（PeterStas）博士说：“这一成就是科萨诺健康（Corsano Health）在其随时随地提供持续患者监测的使命中的一个重要里程碑。”。

“We take pride in delivering a proven and reliable digital health system that accelerates clinical trials and generates unparalleled insights to develop life-saving therapies faster.”

“我们为提供一个经过验证和可靠的数字健康系统而感到自豪，该系统可以加速临床试验，并产生无与伦比的见解，以更快地开发挽救生命的疗法。”

According to analyst Straits Research, RPM and the increasing prevalence of chronic conditions are the main drivers of a global patient monitoring market which is growing by 7.3% annually, and will be worth $91.04 billion by 2031. The analyst suggests that RPM’s capacity to lower costs and enhance outcomes is “transforming” healthcare provision in the US..

根据Straits Research的分析，RPM和慢性病患病率的增加是全球患者监测市场的主要驱动因素，该市场每年以7.3%的速度增长，到2031年将达到910.4亿美元。该分析师表示，RPM降低成本和提高成果的能力正在“改变”美国的医疗保健服务。。

Reduced overall healthcare costs, fewer hospital readmissions, improved patient mobility, and insights that can be captured in real-time to provide a more streamlined patient experience are also widely seen as potential benefits of RPM implementation.

降低总体医疗保健成本，减少再入院，改善患者移动性，以及可以实时捕获以提供更简化的患者体验的见解，也被广泛视为RPM实施的潜在好处。

Meeting the integration challenge

迎接集成挑战

However, integration remains an important challenge for developers and digital health leaders as they seek to enable and realise those benefits. The Corsano CardioWatch System includes an API and Software Development Kit (SDK), which allows providers of RPM platforms and researchers to build interfaces between the device and their own systems..

然而，对于开发人员和数字健康领导者来说，集成仍然是一个重要的挑战，因为他们寻求实现这些好处。Corsano CardioWatch系统包括一个API和软件开发工具包（SDK），它允许RPM平台的提供商和研究人员在设备和他们自己的系统之间构建接口。。

The system is also integrated with third-party devices for displaying and monitoring physiological signs including spot monitoring of non-invasive blood pressure (NIBP), lung function and spirometry, weight, and continuous monitoring of axillary temperature.

该系统还与第三方设备集成，用于显示和监测生理体征，包括无创血压（NIBP）的现场监测，肺功能和肺活量测定，体重以及腋窝温度的连续监测。

Other challenges for RPM adoption include patient participation in the system and adherence to its use, and the burden of data management and interpretation which new systems can impose on healthcare professionals.

RPM采用的其他挑战包括患者参与系统并遵守其使用，以及新系统可能给医疗保健专业人员带来的数据管理和解释负担。

As a highly automated, non-intrusive solution, the CardioWatch System can assist with the creation of personalised treatment plans which help patients to feel more motivated to participate in their own care, improving outcomes and providing a better patient experience.

作为一种高度自动化的非侵入性解决方案，CardioWatch系统可以帮助创建个性化治疗计划，帮助患者更有动力参与自己的护理，改善结果并提供更好的患者体验。

The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or at home by trained healthcare professionals. For them, the system enables in-house monitoring – for example, notifying them when physiological data falls outside selected parameters while freeing them from manual monitoring tasks. .

该手镯适用于医院或专业护理机构等专业医疗机构，或由受过训练的医疗保健专业人员在家使用。对于他们来说，该系统可以实现内部监测-例如，当生理数据超出选定参数时通知他们，同时将他们从手动监测任务中解放出来。。

Find out more at Corsano Health.

在Corsano Health了解更多信息。