Irvine, Calif–based Masimo announced on July 2 that FDA has granted 510(k) clearance of its Root patient monitoring and connectivity platform. Key features of the platform include built-in connectivity for stand-alone devices, expandibility via proprietary or third-party modules, and Bluetooth and Wi-Fi wireless functionality.
Each Root can be used as a connectivity gateway to connect multiple stand-alone devices—such as IV pumps, ventilators, hospital beds, and other patient monitors—when used as part of the optional Iris connectivity package in Masimo Patient SafetyNet. Iris allows stand-alone device information to be remotely viewed with Patient SafetyNet, transmitted through notification systems, or sent to electronic health record (EHR) systems to facilitate better patient care.
The platform can be expanded through Masimo Open Connect (MOC-9) with modules from Masimo or other companies. Masimo’s ISA CO2 module for Root provides ETCO2 and respiratory rate measurements. New MOC-9 modules will require new 510(k) clearances.
Root is also designed to allow other companies to expand the platform’s measurements with their own measurements through Masimo Open Connect (MOC-9) by following Masimo’s established development and validation process.
“With the new FDA clearance for Root, Masimo is eager to help US clinicians usher in a new era of patient care and improved patient safety with a platform that should measurably improve the performance and cost curve,” said Joe Kiani, founder and CEO of Masimo. “Root can be a hub at the bedside, enable Masimo’s breakthrough noninvasive measurements to be used by experts and novices with the trend and analog views, take advantage of a rich set of additional measurements, and allow other companies a robust platform on which to develop other innovative measurements via MOC-9.”
For more information about Root, visit the Masimo website.