FDA OKs Masimo’s Stork Home Baby Monitoring System

Masimo has won U.S. Food and Drug Administration (FDA) clearance of its Stork baby monitoring system for prescription, home use for healthy and sick babies 0-18 months old.
 
When prescribed, parents and family members can receive alarms about their baby’s oxygen saturation (SpO₂), pulse rate, and skin temperature. Vital signs data can be remotely shares with clinicians, and Stork also issues an alert if the baby turns over and is sleeping face down, which can be dangerous.
 
Stork officially earned the FDA nod on December 15. Masimo began the U.S. launch to major retailers in August, after starting initial launch in May.
 
Stork’s sensor technology rests in the Stork boot, made from soft, medical-grade silicone that conforms gently to skin and is available in three sizes. The Stork Vitals+ bundle includes the boot with senso, as well as a 2K Quad High-Definition capable camera with technology supported by Like Minded Labs’ TODA platform.
 
The camera hardware and software architecture were engineered to leverage and be compatible with future edge artificial intelligence (AI)-based features, which Masimo said are in development.
 
“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.”