Owlet Achieves De Novo FDA-Clearance For Dream Sock, The First And Only Over-The-Counter, Medical Grade Pulse Oximeter Cleared For Infants
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Owlet, Inc. (NYSE:OWLT) has received De Novo clearance from the U.S. Food and Drug Administration for its Dream Sock, the first over-the-counter medical pulse oximetry solution for infants. The FDA-cleared Dream Sock will monitor and display infants' health readings, including pulse rate and oxygen saturation level, and will alert caregivers if readings fall outside of preset ranges. The company plans to make these features available to all existing and new Dream Sock users upon launch. The clearance follows the company's previous FDA clearance of BabySat, a prescription monitoring system.
November 09, 2023 | 1:37 pm
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Owlet's FDA clearance for its Dream Sock, a medical pulse oximetry solution for infants, could potentially boost the company's market position and sales. The clearance also validates the company's technology and could increase investor confidence.
FDA clearance is a significant milestone for health tech companies as it validates the safety and effectiveness of their products. This clearance could potentially increase Owlet's sales as it allows the company to market its Dream Sock as an FDA-cleared product. It could also boost investor confidence in the company's technology and future prospects.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100