Fierce Biotech May 7, 2024
Heather Landi

Masimo secured FDA clearance for its Stork baby monitoring system that can help track certain vital signs in healthy infants up to 18 months old and provide alarms to parents or caregivers.

The newly bestowed 510(k) nod for the over-the-counter version of Masimo’s Stork enables parents to buy the monitoring tech without the need for a doctor’s prescription.

The OTC Stork utilizes the same Masimo pulse oximetry technology that monitors more than 10 million babies in hospitals every year and is used at nine of the top 10 U.S. hospitals, according to the company.

The FDA-cleared OTC version of Masimo Stork monitors a baby’s key vitals data including oxygen saturation level (SpO2), pulse rate (PR) and skin temperature. The tech...

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Topics: FDA, Govt Agencies, Medical Devices
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