FDA Clears Home Use for Masimo’s Rad-97 Pulse CO-Oximeter

Masimo announced FDA clearance for home use of the Rad-97 Pulse CO-Oximeter. Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion SET pulse oximetry and upgradeable rainbow technologies, in a compact, standalone monitor that combines advanced connectivity and communication capabilities for telehealth with an interface easily customized for use at home.
 
With an ever increasing number of patients receiving care at home, there is a growing need for high-quality home monitoring and telehealth equipment. Rad-97, in addition to SET pulse oximetry and advanced parameter monitoring technology through rainbow noninvasive monitoring, is available with optional integrated blood pressure and capnography measurements. Its innovative communication capabilities allow monitoring data from a variety of third-party Bluetooth-enabled devices used at home, including thermometers, weight scales, and glucometers, to seamlessly transfer to Rad-97—and from there to anywhere in the world, in real time. The optional integrated camera allows remote clinicians to interact with patients over live audio and video. Rad-97 brings hospital-grade technology to the home in a single, integrated device that is a monitoring, connectivity, and telecommunications hub.
 
With its built-in enterprise WiFi capability, Rad-97 has the ability to connect wirelessly from the home to supplemental patient monitoring systems in the hospital, including Masimo Patient SafetyNet, allowing clinicians to remotely observe patient status while facilitating automatic data transfer to hospital electronic medical record (EMR) systems. Rad-97 can trend and store data for up to 96 hours.
 
With its intuitive touchscreen interface, Rad-97 is easy to use for clinicians and non-clinicians alike, and can be easily customized to meet the needs of home users. The device can be configured in Home mode, which streamlines basic utility, giving home users access to applicable settings and messages, while hiding others and locking alarm settings, minimizing the chances of inadvertent interaction.
 
Joe Kiani, founder and CEO of Masimo, said, “Rad-97 is well-suited for a variety of care settings, now including home. Facilitated by its powerful connectivity and telehealth capabilities, Rad-97 allows clinicians to remotely interact with patients, as well as monitor their status and spot trends from afar through automated data collection and transfer.”