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Owlet推出两款通过FDA认证的设备Dream Sock®和BabySat ™,改变婴儿护理方式

Owlet Transforms Infant Care with the Launch of Two FDA-Cleared Devices – Dream Sock ® and BabySat ™

businesswire 等信源发布 2024-01-08 20:30

可切换为仅中文


LEHI, Utah--(BUSINESS WIRE)--Owlet, Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer of smart infant monitoring, today announces the launch and availability of Dream Sock® and BabySat™, two medical devices with recent clearances from the U.S. Food and Drug Administration (“FDA”). Both innovations deliver real-time health insights with medical-grade accuracy and unprecedented advancements for at-home infant care..

犹他州莱希市——(商业新闻短讯)——智能婴儿监测的先驱Owlet公司(纽约证券交易所:OWLT)今天宣布推出Dream Sock®和BabySat™, 最近获得美国食品和药物管理局(“FDA”)批准的两种医疗器械。这两项创新都以医学级的准确性提供实时健康见解,并为家庭婴儿护理带来前所未有的进步。。

“We are on a mission to help parents monitor what matters most and are proud to now offer two FDA-cleared, at-home infant monitors to countless parents who want and need more information on their baby’s well-being,” said Kurt Workman, Owlet Chief Executive Officer and Co-Founder. “Both the FDA-cleared Dream Sock and BabySat devices are a representation of our endless commitment to providing clarity and peace of mind for parents, while also setting new standards in the industry of infant care.”.

Owlet首席执行官兼联合创始人库尔特·沃克曼(KurtWorkman)表示:“我们的使命是帮助父母监测最重要的事情,现在我们很骄傲地为无数想要并需要更多婴儿健康信息的父母提供两台FDA认可的家中婴儿监护仪。”。“FDA批准的Dream Sock和BabySat设备代表了我们为父母提供清晰和安心的无限承诺,同时也为婴儿护理行业制定了新标准。”。

According to a survey, parents lose a staggering 133 nights of sleep during the first year of their newborn’s life1. Additionally, parents will experience more than three million emergency care visits for their infants each year2, and, annually, more than two million children under the age of five have outpatient visits for respiratory syncytial virus (“RSV”)3.

根据一项调查,父母在新生儿出生后的第一年就失去了惊人的133个晚上的睡眠。此外,父母每年将为其婴儿接受300多万次紧急护理2,每年有200多万名5岁以下儿童因呼吸道合胞病毒(“RSV”)3进行门诊就诊。

Dream Sock and BabySat are designed to arm caregivers with the tools to combat these common stressors – being clinically proven to accurately track and display an infant’s vital signs and notify parents in real-time so they can take action if required..

Dream Sock和BabySat旨在为护理人员提供应对这些常见压力源的工具,经临床证明可以准确跟踪和显示婴儿的生命体征,并实时通知父母,以便他们在需要时采取行动。。

FDA-Cleared Dream Sock

FDA批准的Dream袜子

Since achieving its De Novo clearance from the FDA in November 2023, Dream Sock continues to be the first-of-its-kind medical pulse oximetry solution for infants without the need for a prescription. Rigorously tested in both hospital and at-home environments and found to be compliant with all relevant performance and safety standards, the Dream Sock device provides accurate and actionable data to parents..

自2023年11月获得FDA的从头批准以来,Dream Sock仍然是第一款无需处方的婴儿医用脉搏血氧饱和度测定解决方案。Dream Sock设备在医院和家庭环境中经过严格测试,符合所有相关的性能和安全标准,可为父母提供准确可行的数据。。

“Dream Sock is a breakthrough product for the industry and expands our medical-grade monitoring technology to all consumers,” said Dr. Alisa Niksch, Pediatric Cardiologist and Senior Director of Medical Affairs at Owlet. “This device will equip parents of otherwise healthy babies with the real-time data they need to make informed care decisions for their infants.

Owlet的儿科心脏病专家兼医疗事务高级主管Alisa Niksch博士说:“Dream Sock是业界的突破性产品,它将我们的医疗级监测技术扩展到了所有消费者。”。“该设备将为其他健康婴儿的父母提供所需的实时数据,以便他们为婴儿做出明智的护理决策。

Owlet is dedicated to advancing the capabilities of Dream Sock to enhance care for infants in the home.”.

Owlet致力于提高Dream Sock的能力,以增强对家中婴儿的护理。”。

Caregivers of healthy babies between 1-18 months and 6-30 lbs can now track their infant’s Live Health Readings, including pulse rate and oxygen saturation level, in the Owlet Dream App (iOS & Android), as well as receive real-time Health Notifications for low pulse rate, high pulse rate, and low oxygen.

1-18个月至6-30磅健康婴儿的护理人员现在可以在Owlet Dream应用程序(iOS和Android)中跟踪婴儿的实时健康读数,包括脉搏率和血氧饱和度,并接收低脉搏率,高脉搏率和低氧的实时健康通知。

These features are available to both existing and new Dream Sock users who opt to enable these features in the Dream App..

选择在Dream应用程序中启用这些功能的现有和新Dream Sock用户都可以使用这些功能。。

FDA-Cleared BabySat

FDA批准的BabySat

The BabySat pulse oximetry monitoring system combines hospital-grade accuracy with Owlet’s modern and wire-free sock design, and is intended for infants between 1-18 months and 6-30 lbs with acute or chronic medical conditions. BabySat also provides the ability to track live vital signs, but is distinct from Owlet’s Dream Sock in that it is available through prescription only, and allows a healthcare provider to set and adjust customizable alarms for oxygen saturation and pulse rate that are tailored to an infant’s individual needs..

BabySat脉搏血氧饱和度监测系统将医院级的准确性与Owlet的现代无线袜子设计相结合,适用于患有急性或慢性疾病的1-18个月至6-30磅的婴儿。BabySat还提供跟踪生命体征的功能,但与Owlet的Dream袜子不同,它只能通过处方获得,并且允许医疗保健提供者根据婴儿的个人需求设置和调整可定制的血氧饱和度和脉搏率警报。。

Research shows there is a 40% decrease in mortality rates with the use of in-home pulse oximetry monitoring to track oxygen saturation levels for complex congenital heart disease in infants4. The availability of the BabySat pulse oximeter for more vulnerable infant populations better connects healthcare providers and caregivers, and ultimately allows caregivers to more confidently care for their little ones at home.

研究表明,使用家庭脉搏血氧饱和度监测来追踪婴儿复杂先天性心脏病的血氧饱和度水平,死亡率降低了40%。BabySat脉搏血氧仪可用于更脆弱的婴儿人群,更好地连接了医疗保健提供者和护理人员,最终使护理人员能够更有信心地在家照顾他们的孩子。

BabySat will also be eligible for insurance reimbursement, increasing affordability and further democratizing access to these advanced monitoring tools. Additional details on BabySat prescription, fulfillment, and insurance reimbursement will be announced soon..

BabySat也将有资格获得保险报销,提高支付能力,并进一步民主化这些先进的监测工具。有关BabySat处方、履行和保险报销的更多详细信息将很快公布。。

“The launch of BabySat is a huge accomplishment for both parents and providers to enhance care coordination outside of the hospital,” said Jim Fidacaro, Owlet Senior Vice President and General Manager of Healthcare. “It extends medical-grade, personalized infant care to the home environment, and with oversight from a physician, parents of babies with health conditions can feel more in control of their little one’s well-being.”.

Owlet高级副总裁兼医疗保健总经理吉姆·菲达卡罗(JimFidacaro)表示:“BabySat的推出对于父母和提供者来说都是一项巨大的成就,可以加强医院外的护理协调。”。“它将医疗级别、个性化的婴儿护理扩展到家庭环境,在医生的监督下,健康状况良好的婴儿的父母可以更好地控制孩子的健康。”。

Owlet is committed to offering products that set a new standard in infant care, combining advanced technology with ease of use to help caregivers have increased peace of mind while monitoring what matters most. For more details on each device and to find out which product is the right choice for your family, visit www.owletcare.com..

Owlet致力于提供在婴儿护理方面树立新标准的产品,将先进技术与易用性相结合,以帮助护理人员在监测最重要的事情的同时增加内心的平静。有关每种设备的更多详细信息,并了解哪种产品适合您的家人,请访问www.owletcare.com。。

About Owlet, Inc.

关于Owlet,Inc。

Owlet was founded by a team of parents in 2012. Owlet’s mission is to empower parents with the right information at the right time, to give them more peace of mind and help them find more joy in the journey of parenting. Owlet’s digital parenting platform aims to give parents real-time data and insights to help parents feel calmer and more confident.

Owlet由一个父母团队于2012年成立。Owlet的使命是在正确的时间为父母提供正确的信息,让他们心情更加平静,帮助他们在育儿的过程中找到更多的乐趣。Owlet的数字育儿平台旨在为父母提供实时数据和见解,帮助父母感到更加冷静和自信。

Owlet believes that every parent deserves peace of mind and the opportunity to feel their well-rested best. Owlet also believes that every child deserves to live a long, happy, and healthy life, and is working to develop products to help further that belief. To learn more, visit www.owletcare.com..

Owlet认为,每一位父母都应该得到内心的平静,并有机会感到自己休息得最好。Owlet还认为,每个孩子都应该过上长寿、幸福和健康的生活,并正在努力开发产品来帮助进一步实现这一信念。要了解更多信息,请访问www.owletcare.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s growth prospects, expanded product offerings and the impacts of the Company’s new FDA-cleared medical devices.

本新闻稿包含1995年《私人证券诉讼改革法案》(“改革法案”)所指的前瞻性声明。本新闻稿中包含的所有与历史事实无关的声明均应视为前瞻性声明,包括但不限于有关公司增长前景、扩大产品供应以及公司新FDA批准的医疗器械影响的声明。

In some cases, you can identify forward-looking statements by terms such as “estimate,” “may,” “believes,” “plans,” “expects,” “anticipates,” “intends,” “goal,” “potential,” “upcoming,” “outlook,” “guidance,” the negation thereof, or similar expressions, although not all forward-looking statements contain these identifying words.

在某些情况下,您可以通过诸如“估计”、“可能”、“相信”、“计划”、“期望”、“预期”、“打算”、“目标”、“潜力”、“即将到来”、“展望”、“指导”、“否定”或类似表达等术语来识别前瞻性陈述,尽管并非所有前瞻性陈述都包含这些识别词。

Forward-looking statements are based on the Company’s expectations at the time such statements are made, speak only as of the dates they are made and are susceptible to a number of risks, uncertainties and other factors. For all such forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Reform Act.

前瞻性声明是基于公司在做出此类声明时的预期,仅在做出声明之日才发表,并且容易受到许多风险、不确定性和其他因素的影响。对于所有此类前瞻性声明,公司要求保护《改革法案》中包含的前瞻性声明的安全港。

The Company’s actual results, performance or achievements may differ materially from any future results, performance or achievements expressed or implied by our forward-looking statements. Many important factors could affect the Company’s future results and cause those results to differ materially from those expressed in or implied by the Company’s forward-looking statements.

公司的实际业绩、业绩或成就可能与我们的前瞻性声明中明示或暗示的任何未来业绩、业绩或成就存在重大差异。许多重要因素可能会影响公司未来的业绩,并导致这些业绩与公司前瞻性声明中表达或暗示的结果存在重大差异。

Such factors include, but are not limited to, (i) the regulatory pathway for Owlet’s products, including submissions to, actions taken by and decisions and responses from regulators, such as the FDA and similar regulators outside of the Unite.

这些因素包括但不限于:(i)猫头鹰产品的监管途径,包括提交给监管机构的文件、监管机构采取的行动以及监管机构的决定和回应,如FDA和美国以外的类似监管机构。

References:

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https://www.cdc.gov/rsv/research/index.html

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