本文摘译自MASSDEVICE 2020年6月2日

以下为详文

飞利浦公司今天宣布，其IntelliVue病人监护仪和主动式显示器已获得FDA紧急使用授权（EUA）。

该公司的MX750 / MX850 型IntelliVue 监护仪和AD75 / D85型主动式显示器，在COVID-19大流行持续期间，获得感染控制协议授权，并可远程为护理人员提供信息。

Philips网站截图

这两款IntelliVue产品去年都获得了CE认证批准，MX750型病人监护仪于今年4月获得了EUA。最新EUA允许飞利浦公司开始向美国的医院交付远程监护产品，同时，该公司今年正准备向FDA提交510(k)许可。

该监护仪和主动式显示器可以展现飞利浦的IntelliVue Horizon Trends信息试图，该视图能展示生命体征方面的偏差；它还具有报警分析和警示报告的功能，可以减轻护理人员的报警疲劳。飞利浦公司在新闻稿中特别指出，该系统最新版本中给出了更新的功能，包括加强网络安全功能的更新。

“全世界都在与COVID-19继续战斗，我们定会加大所有关键解决方案的产量，这些解决方案能够在危机时刻提供帮助。”飞利浦汽车及分析公司的总经理 Peter Ziese 在新闻稿中说道，“给予我们公司MX750型、MX850型监护仪和AD75型、AD85型IntelliVue主动式显示器的FDA EUA，使我们能够为这些远程病人提供监控解决方案，这些方案在ICU中是至关重要的。”

原文：

Philips wins EUA for acute-care patient monitoring

JUNE 2, 2020 BY SEAN WHOOLEY LEAVE A COMMENT

Royal Philips (NYSE:PHG) announced today that it received FDA emergency use authorization (EUA) for its IntelliVue patient monitors and active displays.

The Amsterdam-based company’s IntelliVue monitors MX750/MX850 and active displays AD75/D85 received authorization to support infection-control protocols and provide caregivers information remotely during the ongoing COVID-19 pandemic.

Both sets of IntelliVue products received CE Mark approval last year and the MX750 patient monitor already received EUA in April. The latest EUA allows Philips to begin delivering the remote monitoring products to hospitals in the U.S., while it is preparing to submit to the FDA for 510(k) clearance this year.

The monitors and active displays include Philips’ IntelliVue Horizon Trends information view that shows deviations in vital signs. It also features an alarm advisor and alarm reporting to reduce caregivers’ alarm fatigue. Philips noted in a news release that the systems have updated features, including strengthened cybersecurity functionalities.

“As the world continues to battle against COVID-19, we’re committed to ramping up production of all critical solutions that can help in this time of crisis,” Philips GM of motoring & analytics Peter Ziese said in the release. “This FDA EUA for our MX750 and MX850 monitors and IntelliVue AD75 and AD85 active displays allows us to do that for these remote patient monitoring solutions, which are of vital need in the ICU.

“At Philips, being able to provide the right information at the right time to caregivers has always been a top priority. Now more than ever, there’s an urgent need to make sure those on the frontline have all the available resources at their disposal.”