Both innovations deliver real-time health insights with medical-grade accuracy and unprecedented advancements for at-home infant care.
'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
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. 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.
FDA-Cleared Dream Sock
Since achieving its De Novo clearance from the FDA in
'Dream Sock is a breakthrough product for the industry and expands our medical-grade monitoring technology to all consumers,' said Dr.
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. These features are available to both existing and new Dream Sock users who opt to enable these features in the Dream App.
FDA-Cleared 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.
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. 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.
'The launch of BabySat is a huge accomplishment for both parents and providers to enhance care coordination outside of the hospital,' said
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.
About
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 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.
Forward-Looking Statements
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. 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. 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. 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. 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
Contact:
Email: pr@owletcare.com
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