Owlet has introduced two infant monitoring devices, Dream Sock and BabySat, both designed to provide real-time health insights with medical-grade accuracy for at-home infant care. These devices have recently received FDA 510(k) clearance, marking a significant milestone for the company. Dream Sock, a medical oximetry solution for infants, received FDA de novo clearance in November 2023. It caters to healthy babies aged 1 to 18 months and 6 to 30 pounds, offering live health readings such as pulse rate and oxygen saturation through the accompanying Dream App. The device aims to empower parents by delivering accurate and actionable data, enabling them to make informed care decisions for their infants.
In contrast, BabySat is a pulse oximetry monitoring system that combines hospital-grade accuracy with Owlet's modern and wire-free sock design. Intended for infants aged 1 to 18 months and 6 to 30 pounds with acute or chronic medical conditions, BabySat is only available through prescription. It enables healthcare providers to set and adjust customisable alarms for oxygen saturation and pulse rate, tailored to an infant's individual needs. The launch of BabySat is seen as a significant accomplishment, extending medical-grade, personalised infant care to the home environment and providing parents of babies with health conditions more control over their little one's well-being with oversight from a physician.
Owlet CEO and co-founder Kurt Workman expressed the company's commitment to providing clarity and peace of mind for parents through these FDA-cleared at-home infant monitors. The Dream Sock and BabySat devices represent Owlet's dedication to setting new standards in the infant care industry while leveraging advancements in medical-grade monitoring technology.
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