中國，北京—2024年3月7日—Analog Devices, Inc. (Nasdaq: ADI)宣布，ADI的Sensinel?心肺管理(CPM)系統(tǒng)已獲得美國食品藥物監(jiān)督管理局(FDA) 510(k)認(rèn)證，并正式上市。這款緊湊型可穿戴設(shè)備是一種非侵入式遠(yuǎn)程管理系統(tǒng)，能夠監(jiān)測(cè)心肺生理數(shù)據(jù)，用于心力衰竭等慢性疾病的管理。這是ADI成立59年以來首次獲得的FDA認(rèn)證。

ADI數(shù)字醫(yī)療健康高級(jí)副總裁Patrick O'Doherty表示：“自公司創(chuàng)立以來，ADI一直致力于加速突破性創(chuàng)新，利用創(chuàng)新產(chǎn)品豐富人們的生活。通過將我們?cè)诳纱┐魃w征監(jiān)測(cè)和信號(hào)處理領(lǐng)域的先進(jìn)技術(shù)，與在心臟病專家指導(dǎo)下設(shè)計(jì)的算法相結(jié)合，我們成功研發(fā)出Sensinel CPM系統(tǒng)，它可以精確評(píng)估充血性心力衰竭患者的每日健康狀況。這款以服務(wù)為導(dǎo)向的創(chuàng)新產(chǎn)品，不僅有可能為ADI公司開辟數(shù)十億美元的全新市場(chǎng)，而且能夠提升患者護(hù)理效果，優(yōu)化臨床醫(yī)生的工作流程，并有效降低醫(yī)療成本?！?

目前有超過600萬美國人患有心力衰竭，預(yù)計(jì)到2030年，這一數(shù)字將增至近800萬人。1 目前，心力衰竭每年給美國人帶來約300億美元的醫(yī)療開銷，預(yù)計(jì)到2030年，這項(xiàng)費(fèi)用將攀升至近700億美元，1 其中大約80%是住院治療費(fèi)用。1 過往推出的一些監(jiān)測(cè)類似健康指標(biāo)的解決方案已被證明能夠降低住院率。然而，這些解決方案通常要么是侵入式的，要么監(jiān)測(cè)的數(shù)據(jù)不夠精確和具體，無法在臨床上產(chǎn)生顯著影響。準(zhǔn)確及時(shí)的數(shù)據(jù)至關(guān)重要，這可以讓醫(yī)療團(tuán)隊(duì)提前預(yù)測(cè)并進(jìn)行干預(yù)，從而避免患者因心力衰竭而支付昂貴的住院治療費(fèi)用。

Sensinel CPM系統(tǒng)是針對(duì)心力衰竭等心肺疾病管理的新一代解決方案。它具備一系列生理指標(biāo)監(jiān)測(cè)功能，可以輔助醫(yī)護(hù)團(tuán)隊(duì)更早、更有效、更精確地遠(yuǎn)程管理慢性疾病?；颊呖勺孕信宕鰽DI的Sensinel CPM可穿戴設(shè)備，在家庭護(hù)理環(huán)境下只需佩戴三到五分鐘。佩戴后，設(shè)備會(huì)采集患者的心肺健康數(shù)據(jù)，并通過蜂窩鏈路將數(shù)據(jù)自動(dòng)上傳至ADI的Sensinel CPM云平臺(tái)（無需患者自備互聯(lián)網(wǎng)連接），并利用ADI的Sensinel CPM智能算法在云端進(jìn)行進(jìn)一步的分析處理。

美國紐約市西奈山莫寧賽德醫(yī)院（Mount Sinai Morningside）心臟科主任Sean Pinney博士表示：“對(duì)于臨床醫(yī)生來說，盡早發(fā)現(xiàn)患者的生理變化是避免患者因心力衰竭入院治療的關(guān)鍵。ADI的Sensinel CPM系統(tǒng)是一種高度準(zhǔn)確、可重復(fù)且可靠的解決方案，有助于提升我們對(duì)病癥發(fā)展的預(yù)見性，從而更好地護(hù)理患者?！?

ADI院士兼ADI醫(yī)療產(chǎn)品管理總監(jiān)Venu Gopinathan博士表示：“在管理心力衰竭等慢性疾病時(shí)，及早調(diào)整治療措施以控制病情、避免住院，是非常重要的。目前其他一些非侵入式解決方案無法提供足夠具體的數(shù)據(jù)，不能滿足臨床醫(yī)生有效進(jìn)行早期干預(yù)的需求。我們研發(fā)的新型心肺管理系統(tǒng)能夠無縫融入護(hù)理工作流程，通過進(jìn)行多種生理指標(biāo)測(cè)量幫助醫(yī)護(hù)團(tuán)隊(duì)盡早作出準(zhǔn)確的臨床決策，同時(shí)避免了信息過載的問題?！?

ADI公司的Sensinel CPM系統(tǒng)現(xiàn)已上市。更多信息，請(qǐng)?jiān)L問sensinel.analog.com/ 。

關(guān)于Sensinel by Analog Devices?

Senseless by Analog Devices是一個(gè)全新的可穿戴醫(yī)療健康系列，旨在從根本上改變慢性疾病的管理方式，讓患者能夠以負(fù)擔(dān)得起的方式提高生活質(zhì)量。該系列的首款產(chǎn)品Sensinel CPM系統(tǒng)是一種非侵入式的家庭護(hù)理方案，能夠監(jiān)測(cè)心肺生理數(shù)據(jù)，用于心力衰竭等慢性疾病的管理。推出Sensinel系列的Analog Devices, Inc.是一家全球領(lǐng)先的半導(dǎo)體公司，擁有超過50年的醫(yī)療健康行業(yè)經(jīng)驗(yàn)，特別是在檢測(cè)、測(cè)量、計(jì)算、連接和電源等技術(shù)領(lǐng)域，推動(dòng)加速人類的突破性創(chuàng)新，使我們的生活和世界更加豐富多彩。

關(guān)于ADI公司

Analog Devices, Inc. (NASDAQ: ADI)是全球領(lǐng)先的半導(dǎo)體公司，致力于在現(xiàn)實(shí)世界與數(shù)字世界之間架起橋梁，以實(shí)現(xiàn)智能邊緣領(lǐng)域的突破性創(chuàng)新。ADI提供結(jié)合模擬、數(shù)字和軟件技術(shù)的解決方案，推動(dòng)數(shù)字化工廠、汽車和數(shù)字醫(yī)療等領(lǐng)域的持續(xù)發(fā)展，應(yīng)對(duì)氣候變化挑戰(zhàn)，并建立人與世界萬物的可靠互聯(lián)。ADI公司2023財(cái)年收入超過120億美元，全球員工約2.6萬人。攜手全球12.5萬家客戶，ADI助力創(chuàng)新者不斷超越一切可能。更多信息，請(qǐng)?jiān)L問www.analog.com。

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Forward-Looking Statements

This press release contains forward-looking statements, which address a variety of subjects including, for example, statements regarding applications, benefits and growth opportunities related to Sensinel or other healthcare wearables; and other future events. Statements that are not historical facts, including statements about our beliefs, plans and expectations, are forward-looking statements. Such statements are based on our current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward-looking statements: the effects of business, economic, political, legal and regulatory uncertainty or conflicts upon our global operations; changes in demand for semiconductors and the related changes in demand and supply for our products; manufacturing delays, product availability and supply chain disruptions; our future liquidity, capital needs and capital expenditures; our development of technologies and research and development investments; our ability to compete successfully in the markets in which we operate; changes in our estimates of our expected tax rates based on current tax law; adverse results in litigation matters; the risk that we will be unable to retain and hire key personnel; security breaches or other cyber incidents; unanticipated difficulties or expenditures relating to integrating Maxim Integrated Products, Inc. (“Maxim”); uncertainty as to the long-term value of our common stock; and the risk that expected benefits, synergies and growth prospects of acquisitions, including those from our acquisition of Maxim, may not be fully achieved in a timely manner, or at all. For additional information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to our filings with the Securities and Exchange Commission, including the risk factors contained in our most recent Annual Report on Form 10-K. Forward-looking statements represent management’s current expectations and are inherently uncertain. Except as required by law, we do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances.

參考文獻(xiàn)

1.美國心臟協(xié)會(huì)，“Understand your risk for heart failure”（了解心力衰竭的風(fēng)險(xiǎn)），美國心臟協(xié)會(huì)網(wǎng)站，發(fā)布于2017年5月9日，更新于2023年6月13日，訪問于2024年3月5日。 https://www.heart.org/en/health-topics/heart-failure/causes-and-risks-for-heart-failure/understand-your-risk-for-heart-failure

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