Masimo, a prominent player in cutting-edge monitoring technologies for leading hospitals, recently obtained FDA clearance for its Stork™ baby monitoring system. This revolutionary system, harnessing Masimo's proven sensor technology utilized in monitoring over 10 million infants annually in hospitals, is now authorized for prescription use with both healthy and sick infants aged 0-18 months. Stork delivers continuous and precise monitoring of a baby's health and is available nationwide as a non-medical device for general health and wellness purposes.

With FDA clearance for prescription use, Stork can now be prescribed for ongoing monitoring of infants at home as a medical device, offering parents and caregivers real-time alerts on vital signs such as oxygen saturation (SpO2), pulse rate (PR), and skin temperature. These vital signs data can be remotely shared with clinicians, facilitating communication and care coordination. Additionally, Stork incorporates a safety feature that alerts parents if their baby turns over and sleeps face down, a potential risk for infants.Stork utilizes Signal Extraction Technology® (SET®), the same technology applied in neonatal intensive care units (NICUs) for years, contributing to improved health outcomes for vulnerable newborns. 

Masimo Stork has received 510(k) clearance for prescription use, specifically intended for monitoring multiple physiological parameters in home environments. It is indicated for spot-checking and continuous monitoring of SpO2 and PR in infants and neonates, even under motion and low perfusion conditions. Additionally, Stork is approved for continuous skin temperature measurements in infants and neonates.

Source: prnewswire.com