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BioWorld - Thursday, April 30, 2026
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Home » Masimo’s Stork takes flight with FDA’s over-the-counter clearance
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Masimo’s Stork takes flight with FDA’s over-the-counter clearance

May 6, 2024
By Annette Boyle
Masimo Corp.’s pride and joy, the Stork baby monitor, achieved a new developmental milestone with U.S. FDA clearance for over-the-counter marketing. The agency cleared Stork, which monitors key vital signs including oxygen saturation level, pulse rate and skin temperature, for use on a prescription basis in December. It has been available in the U.S. as a health and wellness device since August 2023.
Medical technology Regulatory Medical devices Monitoring FDA

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