The Company filed a 510(k) premarket notification for its prescription-only medical device to be used in-home for babies under the supervision of a physician
Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”) for a new prescription monitoring device for infants. The Company’s device, which uses pulse oximetry technology, is intended to be prescribed by physicians for assisting with the in-home monitoring of babies under a physician’s care. The device provides alerts to parents when their baby’s heart rate or oxygen saturation level (SpO2) does not fall within prescribed ranges.
“As noted in our recent earnings release, this is a major milestone for Owlet as we work toward our mission, representing several years of work, including clinical and safety studies,” said Kurt Workman, Owlet President, Chief Executive Officer and Co-Founder. “This device will help the most vulnerable of babies, and we are optimistic about and excited for the opportunity ahead as we develop and expand our core technologies to include medical devices. I’m grateful to our team who has worked tirelessly on this initiative, and we look forward to working through the FDA review process.”
About 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 more calm and confident. Owlet believes that every parent deserves peace of mind and the opportunity to feel their well-rested best. To learn more, visit www.owletcare.com.