IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today FDA clearance of MightySat® Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available Over-The-Counter (OTC) direct to consumers without a prescription. All other pulse oximeters available at drug stores and online and sold direct to consumers are not FDA cleared and should not be relied upon for medical use; many of them have been reported to give erroneous measurements.1 This clearance brings consumers a pulse oximeter medical device powered by Masimo SET® pulse oximetry—the same technology relied on by hospitals and clinics around the world to monitor more than 200 million patients every year2 and shown to have no clinically significant difference in accuracy or bias between light- and dark-skinned individuals.3 Starting today, the MightySat Medical Pulse Oximeter can be purchased at masimo.com, and it will soon be available for purchase at retail and drug stores across the country..

加利福尼亚州欧文市（商业新闻短讯）--Masimo（纳斯达克代码：MASI）今天宣布FDA批准MightySat®Medical，这是第一个也是唯一一个FDA批准的非处方（OTC）直接向消费者提供的医用指尖脉搏血氧仪。药店和网上提供的所有其他直接出售给消费者的脉搏血氧仪均未经FDA批准，不应用于医疗用途；据报道，其中许多人给出了错误的测量结果。1这项许可为消费者带来了一种由Masimo SET®脉搏血氧仪驱动的脉搏血氧仪医疗设备，这与世界各地的医院和诊所每年监测2亿多患者所依赖的技术相同2，并且显示在浅肤色和深色皮肤的个体之间，在准确性或偏倚方面没有临床上的显着差异。3从今天开始，MightySat medical pulse oximeter可以在Masimo.com上购买，不久将在全国的零售店和药店购买。。

Joe Kiani, Founder and CEO of Masimo, said, “Until now, consumers and even healthcare providers had no way of knowing what pulse oximeter they could trust to use at home. On the internet and even in drug stores, they are inundated with a myriad of products that are unreliable, with misleading advertisements about their abilities to provide accurate measurements of oxygen saturation and pulse rate.

Masimo创始人兼首席执行官乔·基亚尼表示，“到目前为止，消费者甚至医疗保健提供者都不知道他们可以信任在家使用什么脉搏血氧仪。在互联网上，甚至在药店，他们被无数不可靠的产品淹没，并有误导性广告宣传他们提供准确的血氧饱和度和脉搏率测量的能力。

This clearance of MightySat Medical for consumers eliminates the confusion, placing an FDA-cleared, accurate, reliable, and revolutionary SET® pulse oximeter, with technology that hospitals have been using for more than 25 years, directly into their hands. Healthcare providers can also now be confident when referring their patients to get MightySat Medical knowing that it has actually been cleared by the FDA as an OTC medical pulse oximeter.”.

MightySat Medical为消费者提供的这一许可消除了混乱，将FDA批准的、准确、可靠且具有革命性的SET®脉搏血氧仪直接交到他们手中，该血氧仪采用了医院使用25年以上的技术。医疗保健提供者现在也可以自信地将患者转介给MightySat Medical，因为他们知道它实际上已被FDA批准为OTC医用脉搏血氧仪。”。

In 2021, the FDA issued a safety communication clarifying that it does not review the accuracy of “health and wellness” pulse oximeters and highlighting the common limitations of both health and wellness and some prescription pulse oximeters—such as difficulty measuring accurately during patient motion, on patients with poor circulation (low perfusion), and on darker skin pigmentation.4 The overwhelming majority of consumers say that device accuracy—measurements they can trust—is their top priority when choosing a pulse oximeter.

2021年，FDA发布了一份安全通讯，澄清它没有审查“健康与健康”脉搏血氧仪的准确性，并强调了健康与健康以及一些处方脉搏血氧仪的共同局限性，例如在患者运动过程中难以准确测量循环不良（低灌注）的患者，绝大多数消费者表示，在选择脉搏血氧仪时，他们可以信任的设备精度测量是他们的首要任务。

MightySat Medical provides a direct-to-consumer option for a medical device with hospital-grade pulse oximetry technology, Masimo SET®, whose performance has been reviewed and cleared by the FDA for medical use. MightySat Medical provides accurate and reliable oxygen saturation (SpO2) and pulse rate (PR) measurements on patients of all skin colors and patients with low perfusion..

MightySat Medical为具有医院级脉搏血氧仪技术Masimo SET®的医疗设备提供了直接面向消费者的选择，该技术的性能已被FDA审查并批准用于医疗用途。MightySat Medical为所有肤色的患者和低灌注患者提供准确可靠的血氧饱和度（SpO2）和脉搏率（PR）测量。。

Consumers with diagnosed breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung cancer, flu, pneumonia, or COVID-19 depend on accurate assessment of their arterial blood oxygen saturation that they can confidently share with their healthcare providers.

被诊断患有呼吸问题或肺部疾病（如哮喘，慢性阻塞性肺病（COPD），肺癌，流感，肺炎或新型冠状病毒肺炎）的消费者依赖于对其动脉血氧饱和度的准确评估，他们可以自信地与医疗保健提供者分享。

Prior to the FDA clearance of MightySat Medical, consumers were only able to buy unregulated health and wellness devices without a prescription. Now, MightySat Medical with Masimo SET® provides an FDA-cleared medical device with validated accuracy without the need for a prescription. SET®, available in numerous hospital devices, is the primary pulse oximetry technology at 9 of the top 10 U.S.

在FDA批准MightySat Medical之前，消费者只能在没有处方的情况下购买不受监管的健康和保健设备。现在，MightySat Medical with Masimo SET®提供了一种FDA认可的医疗设备，无需处方即可验证其准确性。SET®可用于多种医院设备，是美国前10名中的9名的主要脉搏血氧仪技术。

hospitals listed in the U.S. News and World Report Honor Roll.5 In addition, over 100 independent and objective studies have shown that SET® outperforms other pulse oximetry technologies.6.

《美国新闻与世界报道》荣誉榜上列出的医院。5此外，超过100项独立和客观的研究表明，SET®优于其他脉搏血氧仪技术。

Peter Pronovost, MD, PhD, Chief Quality and Clinical Transformation Officer, University Hospitals, Cleveland, commented, “More and more care is moving to the patient’s home. Patients now have the ability to monitor their oxygen levels and pulse rate, which can help them know when they need to seek care.

克利夫兰大学医院首席质量和临床转化官、医学博士彼得·普洛诺沃斯特（PeterPronovost）评论道：“越来越多的护理转移到患者家中。患者现在能够监测他们的氧气水平和脉搏频率，这可以帮助他们知道何时需要寻求护理。

Yet to be useful, their pulse oximetry data must be accurate and the accuracy of these devices varies widely. Doctors and nurses rely on Masimo technology in the hospital.”.

然而，为了有用，他们的脉搏血氧仪数据必须准确，并且这些设备的准确性差异很大。医生和护士在医院依靠Masimo技术。”。

Masimo MightySat Medical is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

Masimo MightySat Medical旨在抽查动脉血红蛋白（SpO2）和脉搏率（PR）的功能性氧饱和度。

MightySat Medical is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

MightySat Medical适用于18岁及以上在无运动条件下灌注良好或灌注不良的个体。

MightySat Medical is not intended for the diagnosis or screening of lung disease. Treatment decisions using the device should only be made under the advice of a healthcare provider.

MightySat Medical不用于诊断或筛查肺部疾病。使用该设备的治疗决策只能在医疗保健提供者的建议下做出。

@Masimo | #Masimo

@Masimo.#Masimo

About Masimo

关于Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio.

Masimo（纳斯达克股票代码：MASI）是一家全球医疗技术公司，开发和生产各种行业领先的监测技术，包括创新的测量、传感器、患者监护仪以及自动化和连接解决方案。此外，Masimo Consumer Audio拥有八个传奇音频品牌，包括Bowers&Wilkins、Denon、Marantz和Polk Audio。

Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.6 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,7 improve CCHD screening in newborns8 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.9-12 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,2 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S.

我们的使命是改善生活，改善患者预后，降低护理成本。1995年推出的Masimo SET®运动测量和低灌注™脉搏血氧仪已经在100多项独立和客观的研究中显示出优于其他脉搏血氧仪技术。6 Masimo SET®也被证明可以帮助临床医生减少新生儿严重的早产儿视网膜病变，7改善新生儿的CCHD筛查8，当在手术后病房使用Masimo Patient SafetyNet™进行连续监测时，可以减少快速反应团队的激活、ICU转移和成本。9-12 Masimo SET®估计可用于全球领先医院和其他医疗机构的2亿多患者，2是2022-23年美国排名前10名医院中9家的主要脉搏血氧仪。

News and World Report Best Hospitals Honor Roll.5 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™).

新闻和世界报道最佳医院荣誉榜。5 2005年，Masimo引入了rainbow®脉搏CO血氧测定技术，可以无创和连续监测以前只能有创测量的血液成分，包括总血红蛋白（SpHb®）、氧含量（SpOC™）、碳氧合血红蛋白（SpCO®）、高铁血红蛋白（SpMet®）、Pleth变异指数（PVi®），RPVi™（rainbow®PVi）和氧气储备指数（ORi™）。

In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possib.

2013年，Masimo推出了Root®患者监测和连接平台，该平台从头开始构建，与possib一样灵活且可扩展。

RPVi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

RPVi尚未获得FDA 510（k）许可，也无法在美国销售。商标Patient SafetyNet的使用已获得大学健康系统联盟（University HealthSystem Consortium）的许可。

References

参考文献

Lipnick M, Feiner J, Au P, Bernstein M, Bickler P. The Accuracy of 6 Inexpensive Pulse Oximeters Not Cleared by the Food and Drug Administration: The Possible Global Public Health Implications. Anesth Anal. Aug 2016. 123(2)338-345. DOI: 10.1213/ANE.0000000000001300.

Lipnick M，Feiner J，Au P，Bernstein M，Bickler P.食品和药物管理局未批准的6种廉价脉搏血氧仪的准确性：可能的全球公共卫生影响。肛门麻醉。2016年8月。123（2）338-345。DOI:10.1213/ANE.0000000000001300。

Estimate: Masimo data on file.

估计：Masimo数据存档。

Barker SJ, Wilson WC. Racial effects on Masimo pulse oximetry: a laboratory study. J Clin Monit Comput. 2023 Apr;37(2):567-574. DOI: 10.1007/s10877-022-00927-w.

巴克SJ，威尔逊WC。种族对Masimo脉搏血氧仪的影响：一项实验室研究。J临床监测计算机。2023年4月；37（2）：567-574。DOI:10.1007/s10877-022-00927-w。

https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication

https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication

http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.

已发表的脉搏血氧仪临床研究和Masimo SET®的益处可在我们的网站上找到http://www.masimo.com.比较研究包括独立和客观的研究，这些研究由科学会议上发表的摘要和同行评审的期刊文章组成。

Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.

Castillo A等人。通过改变临床实践和SpO2技术预防早产儿视网膜病变。儿科学报。2011年2月；100（2）：188-92。

de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.

de Wahl-Granelli A等人。脉搏血氧仪筛查对导管依赖性先天性心脏病检测的影响：一项针对39821名新生儿的瑞典前瞻性筛查研究。英国医学杂志。2009年；1月8日；338

Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.

Taenzer A等人。脉搏血氧仪监测对救援事件和重症监护病房转移的影响：前后并发研究。麻醉学。2010:112（2）：282-287。

Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

Taenzer A等人。术后监测-达特茅斯经验。麻醉患者安全基金会新闻稿。2012年春夏。

McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

McGrath S等人。普通护理病房的监测管理：策略，设计和实施。质量和患者安全联合委员会杂志。2016年7月；42（7）：293-302。

McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

McGrath S等人。与镇静和镇痛药物相关的住院患者呼吸停止：持续监测对患者死亡率和严重发病率的影响。J患者Saf。2020年3月14日DOI:10.1097/PTS.0000000000000696。

Forward-Looking Statements

前瞻性声明

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of MightySat® and SET®.

本新闻稿包括1933年《证券法》第27A节和1934年《证券交易法》第21E节中定义的与1995年《私人证券诉讼改革法》相关的前瞻性声明。这些前瞻性声明包括关于MightySat®和SET®潜在有效性的声明。

These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including MightySat and SET®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks that MightySat may not soon be available for purchase at retail and drug stores across the country and online; risks related to COVID-19; as well as other factors discussed in the 'Risk Factors' section of our most recent reports filed with the Securities and Exchange Commission ('SEC'), which may be obtained for free at the SEC's website at www.sec.gov.

这些前瞻性陈述基于对影响我们的未来事件的当前预期，并受到风险和不确定性的影响，所有这些都难以预测，其中许多超出了我们的控制范围，并且由于各种风险因素，可能导致我们的实际结果与前瞻性陈述中表达的结果产生重大不利影响，包括，但不限于：与我们关于临床结果可重复性的假设相关的风险；与我们相信Masimo独特的无创测量技术（包括MightySat和SET®）有助于积极的临床结果和患者安全相关的风险；与我们相信Masimo非侵入性医疗突破提供成本效益高的解决方案和独特优势有关的风险；可能不会很快在全国各地的零售店和药店以及网上购买MightySat的风险；与新型冠状病毒相关的风险；以及我们向美国证券交易委员会（“SEC”）提交的最新报告中“风险因素”部分讨论的其他因素，这些因素可以在SEC的网站www.SEC.gov上免费获得。

Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entir.

虽然我们认为前瞻性声明中反映的期望是合理的，但我们不知道我们的期望是否正确。本新闻稿中包含的所有前瞻性声明均在其完整性中明确限定。