Press release
Masimo Receives FDA Clearance for Stork™ Baby Monitoring System
Stork Provides Continuous Monitoring of Oxygen Saturation, Pulse Rate, and Skin Temperature, with Alarms, for Sick and Healthy Babies at Home IRVINE,
About this update from Masimo Corporation
[{"type":"text","content":"\nStork Provides Continuous Monitoring of Oxygen Saturation, Pulse Rate, and Skin Temperature, with Alarms, for Sick and Healthy Babies at Home\n\n\n IRVINE, Calif.--(BUSINESS WIRE)--\nMasimo (NASDAQ: MASI), a global leader in innovative monitoring technologies used in top hospitals, announced today FDA clearance of Stork™, a revolutionary baby monitoring system, for prescription use with healthy and sick babies 0-18 months of age. Leveraging the same Masimo sensor technology that monitors more than 10 million babies in hospitals every year, Stork provides continuous, accurate monitoring of a baby’s health. Stork is available at retailers nationwide as a non-medical device for general health and wellness purposes. With this clearance, Stork is now available for prescription use to continuously monitor babies at home as a medical device for healthy or sick babies.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231218419637/en/Masimo Stork™ (Photo: Business Wire)\n“When my son was born, we were concerned about his breathing. Our doctor prescribed pulse oximetry monitoring for a week for him. A therapist arrived at our home with a large standalone pulse oximeter made for hospitals, with cables and wires everywhere and tethered to our son, and charged us $5,000 for a week of monitoring,” said Joe Kiani, Founder and CEO of Masimo. “I know how important it is for parents to better understand their baby’s physiological well-being, especially when they are sick, and it’s our privilege to provide them with an easy-to-use, accurate product that allows them to continuously monitor key vital signs for less than one tenth of the cost I paid, and also includes video surveillance.”\n\n\nWhen prescribed, parents and family members will now be able to receive alarms regarding their baby’s oxygen saturation (SpO2), pulse rate (PR), and skin temperature. They will be able to share these vital signs data remotely with clinicians. In addition, Stork alerts parents if their baby turns over and is sleeping face down, which can be dangerous for babies.\n\n\nStork leverages the same technology that has been used on babies in the neonatal intensive care unit (NICU) for years, helping to improve health outcomes for the youngest and most vulnerable patients. Known as Signal Extraction Technol...