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Owlet Response to Opinion Article in JAMA

January 24, 2017

At Owlet, our vision is to improve the health and wellbeing of infants and their families. We believe that parents have a right to know their baby’s heart rate, if they choose. The Owlet Smart Sock uses similar technology, and delivers the same information, to that used in products like Apple Watch and Fitbit. With the Smart Sock and app, our mission is to help parents take a proactive approach to their baby’s health and wellness. By giving parents the right information at the right time, we empower them to make informed choices.

We have invested millions of dollars into data collection and storage, as well as the creation of a clinical team to focus on our mission to further knowledge of the issues affecting infant health.

As a company with more than 80,000 families using the product, we are confident in the positive results these families are experiencing. As evidenced by the continued success, the Owlet Smart Sock is filling a void and responding to the demand from parents for this information. A number of our current customers are physicians and healthcare providers, who have expressed support for the product and the information it provides through its continued use with their own children.

Due to innovations developed by Owlet to lessen false alarms, many users will use the Owlet Sock for several months without ever getting a false alarm, greatly reducing the risk over diagnosis. Additional product enhancements and features include use of wireless technology to eliminate cords as well as a smartphone connectivity integration that fits parents’ lifestyle.

We have done extensive product safety testing, such as biocompatibility studies and FCC testing, and the Owlet Smart Sock is in compliance with U.S. Consumer Product Safety Commission (CPSC) requirements.

We have conducted third-party accuracy studies that were submitted to the FDA as part of our recent 510(k) application, which review is pending for a medical version of the product.

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The Smart Sock is the first baby monitor to track your baby’s oxygen level and heart rate—good indicators of Baby's overall well-being—while they sleep. If your baby’s readings leave preset zones, you'll receive a notification that lets you know your baby really needs you. Now you can feel more confidence, more freedom, and more peace of mind knowing that Owlet is here to help.

Our all-new Smart Sock is the third of its kind and it's smarter than ever.

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2 thoughts on “Owlet Response to Opinion Article in JAMA



Hi Fran! Thank you for your question. As noted in our statement, we submitted a 510(k) for FDA clearance in November. The application is currently pending review.



So we should ignore researchers at one of the finest pediatric hospitals in the world and the AAP and trust you? Submit to same FDA testing for. Radical devices and then maybe we will listen to you.