Masimo, a health technology company that previously had a dispute with Apple over blood oxygen sensing technology, has announced that its wearable Stork baby monitor has been cleared for over-the-counter use by the US Food and Drug Administration. This device is designed for healthy infants up to 18 months old, allowing parents to measure their child’s oxygen saturation level, pulse rate, and skin temperature. The monitor includes visual and audible alarms to alert parents if these metrics fall outside preset ranges. The Stork baby monitor utilizes pulse oximetry technology similar to what is used in hospitals and includes a sensor fitted to a boot worn by the infant.
Masimo has also developed a prescription-only Stork product that will soon be available, which includes different alarm thresholds more suitable for sick babies. The over-the-counter Stork system will be available for purchase online and in stores such as Target and Best Buy this summer. Parents who are concerned about their child’s safety during sleep may choose to use a wearable monitor like the Stork for increased monitoring and real-time tracking of their baby’s health. However, some child health experts caution against relying too heavily on these devices for healthy babies, as they may lead to increased anxiety, false alarms, or a false sense of security.
The American Academy of Pediatrics has expressed concerns about the use of wearable monitoring devices for infants, stating that there is a lack of evidence to support their effectiveness in reducing the risk of infant deaths. They warn that relying too much on these devices may lead to complacency and a decrease in adherence to safe sleep guidelines, which are designed to reduce the risk of Sudden Unintended Infant Death Syndrome (SIDS). Parents who have a sick baby or have concerns about their baby’s health should consult with a doctor before using a monitoring device like the Stork.
In addition to the Stork baby monitor, Masimo also offers a separate, prescription-only version of the product with different alarm thresholds for sick infants. The company’s technology is based on the same pulse oximetry technology used in hospital settings, providing parents with valuable insights into their child’s health. The Stork system can alert parents if the baby is face down, but this feature has not been cleared by the FDA. Masimo plans to update the Stork app this summer to include the newly FDA-cleared algorithms for existing Stork monitors.
Overall, the availability of wearable monitoring devices like the Stork has provided parents with a new tool for monitoring their child’s health in real-time. However, it is important for parents to exercise caution and consult with healthcare professionals before relying solely on these devices. While these monitors can offer peace of mind for some parents, they may also cause unnecessary anxiety or a false sense of security. As the technology continues to evolve, it is critical for parents to stay informed and make informed decisions about the use of wearable monitoring devices for their infants.
