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FDA Clears Masimo’s ‘Stork’ Baby Monitor for Blood Oxygen, Pulse Rate Monitoring

 FDA Clears Masimo’s ‘Stork’ Baby Monitor for Blood Oxygen, Pulse Rate Monitoring


Masimo, the health technology company that made headlines last winter over a dispute with Apple and its blood oxygen sensing technology, said Monday that its wearable Stork baby monitor is now cleared for over-the-counter use by the US Food and Drug Administration.  

Specifically, it’s cleared for healthy infants up to 18 months old whose parents can use the monitor to measure their child’s oxygen saturation level, pulse rate and skin temperature and be notified with “visual and audible alarms” if the oxygen saturation level or pulse rate falls outside preset ranges. 

These metrics are taken via a sensor fitted to a boot the child wears. The setup is similar in theory to Owlet’s baby monitor, the Dream Sock, but the Stork boot is made of medical-grade silicone, and Owlet chose fabric for its sock. In November, Owlet announced FDA clearance for its monitoring system, the first company to get clearance for a type of wearable health care that professionals seem to be hesitant about, out of fear of false alarms or a false sense of security.

Masimo says its baby monitoring system uses the same pulse oximetry technology the company offers in a hospital setting. 

The Stork monitoring system can also alert parents if the baby is face down, by the position of the monitor in the boot, Masimo said, but this feature isn’t cleared by the FDA. 

Masimo's Stork system Masimo's Stork system

The Stork monitor system. 

Masimo

In addition to this over-the-counter Stork system, which has already been available for sale online without FDA clearance for general wellness purposes, Masimo has a separate, prescription-only Stork product that’s set to become available this year. The prescription Stork has different alarm thresholds more appropriate for sick babies, the company said. The regular, over-the-counter Stork isn’t intended for infants with cardiovascular or respiratory issues.

If your baby is sick or has been diagnosed with a health condition, speak with your doctor about appropriate home treatment or a monitoring device. 

The FDA-cleared Stork bundle should be available for purchase this summer online and at brick-and-mortar stores including Target and Best Buy. If you already have a Stork monitor, Masimo says, you can access the freshly FDA-cleared algorithms in an upcoming update to the app this summer. 

Parents with concerns or anxiety around their child’s safety during sleep may turn to a wearable monitor like Stork or Owlet for increased monitoring and real-time tracking on how their baby’s health is doing. But generally speaking, these high-tech wearable monitors have led some child health experts to tell parents to exercise some consideration when buying these devices for healthy babies, as they may lead to more anxiety and false alarms, or to a false sense of security. 

The American Academy of Pediatrics, for example, said in guidance published in 2022 that “data are lacking” on evidence that would support direct-to-consumer heart rate and pulse oximetry monitoring devices to reduce the risk of infant deaths. It said there’s a concern that the increased sense of monitoring may lead to “complacency and decreased adherence to safe sleep guidelines,” which are general sleep safety rules recommended for all babies to reduce the risk of the Sudden Unintended Infant Death Syndrome, including SIDS. 



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