Masimo announces FDA clearance of Radius PCG for the Root patient monitoring and connectivity platform

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Masimo announces FDA clearance of Radius PCG for the Root patient monitoring and connectivity platform

Press releases may be edited for formatting or style | April 12, 2021 Patient Monitors
IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today that Radius PCG™, a portable real-time capnograph with wireless Bluetooth® connectivity, has received FDA 510(k) clearance. Radius PCG connects with the Root® Patient Monitoring and Connectivity Platform to provide seamless, tetherless mainstream capnography for patients of all ages. Radius PCG joins the growing family of tetherless Masimo technologies that includes Radius PPG™, which offers Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, and Radius Tº™, which provides continuous temperature measurements. Radius PCG requires no routine calibration, with accurate end-tidal carbon dioxide (EtCO2) and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds—all in a small, portable package that can fit in the palm of a hand.

“Radius PCG has been a game changer for our clinical team,” commented Joseph DiMartino, MSN RN, NE-BC, CCRN-K, Associate Vice President of Nursing at Temple University Hospital in Philadelphia. “It provides us with a portable and rapid measure of capnography for confirming airway placement in accordance with AHA guidelines.”

Wirelessly connected to Root, Radius PCG presents a compelling mainstream capnography solution, offering:

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Cable-free Capnography: High-quality capnography without a tethered connection to Root reduces the possibility of an interruption in capnography monitoring by minimizing tugging on the breathing circuit. In busy operating rooms, where space is already at a premium, and where capnography cables can easily be pulled and dropped on the floor—potentially damaging the fragile and expensive capnography sensor head—the reduction in clutter may be especially welcome.
Automated Documentation: Root, in conjunction with the Masimo Hospital Automation™ Platform, automates electronic charting of patient data, including the data collected by Radius PCG, in hospital electronic medical record (EMR) systems, to simplify and speed workflows, as well as reduce the likelihood of transcription errors.1
Maximized Data Visibility and Manipulation: Root’s large, multi-touch, high-resolution screen provides an easily interpretable secondary display of large, crisp EtCO2 waveforms, improving visibility and assisting clinicians in identifying wave patterns suggestive of airway obstruction or tube dislodgement. Clearly displayed trend data for up to 96 hours helps clinicians review patient progress over time, helping guide ventilation efforts. And the intuitive touch-screen interface allows clinicians to quickly adjust the trend display range and configure alarm settings to meet the needs of each patient.

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