本文摘譯自MASSDEVICE 2020年6月2日

以下為詳文

飛利浦公司今天宣布，其IntelliVue病人監(jiān)護(hù)儀和主動(dòng)式顯示器已獲得FDA緊急使用授權(quán)（EUA）。

該公司的MX750 / MX850 型IntelliVue 監(jiān)護(hù)儀和AD75 / D85型主動(dòng)式顯示器，在COVID-19大流行持續(xù)期間，獲得感染控制協(xié)議授權(quán)，并可遠(yuǎn)程為護(hù)理人員提供信息。

Philips網(wǎng)站截圖

這兩款I(lǐng)ntelliVue產(chǎn)品去年都獲得了CE認(rèn)證批準(zhǔn)，MX750型病人監(jiān)護(hù)儀于今年4月獲得了EUA。最新EUA允許飛利浦公司開(kāi)始向美國(guó)的醫(yī)院交付遠(yuǎn)程監(jiān)護(hù)產(chǎn)品，同時(shí)，該公司今年正準(zhǔn)備向FDA提交510(k)許可。

該監(jiān)護(hù)儀和主動(dòng)式顯示器可以展現(xiàn)飛利浦的IntelliVue Horizon Trends信息試圖，該視圖能展示生命體征方面的偏差；它還具有報(bào)警分析和警示報(bào)告的功能，可以減輕護(hù)理人員的報(bào)警疲勞。飛利浦公司在新聞稿中特別指出，該系統(tǒng)最新版本中給出了更新的功能，包括加強(qiáng)網(wǎng)絡(luò)安全功能的更新。

“全世界都在與COVID-19繼續(xù)戰(zhàn)斗，我們定會(huì)加大所有關(guān)鍵解決方案的產(chǎn)量，這些解決方案能夠在危機(jī)時(shí)刻提供幫助?！憋w利浦汽車及分析公司的總經(jīng)理 Peter Ziese 在新聞稿中說(shuō)道，“給予我們公司MX750型、MX850型監(jiān)護(hù)儀和AD75型、AD85型IntelliVue主動(dòng)式顯示器的FDA EUA，使我們能夠?yàn)檫@些遠(yuǎn)程病人提供監(jiān)控解決方案，這些方案在ICU中是至關(guān)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.”