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 system, the first company to get clearance for a type of infant monitoring 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.
