Masimo, a health technology company known for its 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 FDA. The monitor is designed for healthy infants up to 18 months old, allowing parents to measure oxygen saturation levels, pulse rate, and skin temperature. It provides visual and audible alarms if these metrics fall outside preset ranges, using a sensor fitted to a boot worn by the child. Masimo’s system uses pulse oximetry technology similar to what is used in hospitals, and it can also detect if the baby is face down, although this feature is not yet FDA-cleared.
In addition to the over-the-counter Stork system, Masimo also offers a prescription-only version for sick babies, with different alarm thresholds. The regular Stork system is not intended for infants with cardiovascular or respiratory issues, and parents are advised to consult with a doctor if their baby is sick or has a health condition. The FDA-cleared Stork bundle is expected to be available for purchase online and in stores like Target and Best Buy this summer. Existing users of the Stork monitor can access the newly FDA-cleared algorithms through an upcoming app update.
While wearable baby monitors like Stork and Owlet offer increased monitoring and real-time tracking of a baby’s health, some experts caution against relying too heavily on these devices for healthy infants. The American Academy of Pediatrics has expressed concerns about the lack of evidence supporting the use of direct-to-consumer monitoring devices to reduce the risk of infant deaths. There is also a worry that reliance on these monitors may lead to complacency and decreased adherence to safe sleep guidelines, which are designed to reduce the risk of Sudden Unexpected Infant Death Syndrome (SUIDS).
Parents who have concerns or anxiety about their child’s safety during sleep may turn to wearable monitors for peace of mind. However, it is important for parents to weigh the potential benefits of these devices against the risks of increased anxiety or false alarms. While technology like the Stork monitor can provide valuable information about a baby’s health, it is not a substitute for medical advice or intervention. Ultimately, parents should consult with healthcare professionals to determine the best course of action for monitoring their baby’s health and safety.
