Industry Press Releases

Masimo Announces CE Marking of radius Capnography ™ for the root ® platform for patient monitoring and connectivity to

Saturday, Nov 02, 2019

Masimo today announced that Radius Capnography ™, a portable real-time capnograph with wireless Bluetooth ® connectivity, has been CE-marked. Radius Capnography combines with the root ® platform for patient monitoring and connectivity to offer patients a seamless, unconnected mainstream capnography all ages. Capnography radius is the second developed by Masimo wireless sensor with radius PPG ™ or radius photoplethysmography the first unconnected sensor solution, the Masimo SET ® Measure-through Motion and Low perfusion ™ offers.

Radius Capnography does not require routine calibration and minimal warm-up time. Fully accurate EtCO 2 and respiratory rate measurements and continuous EtCO 2 waveforms are displayed within 15 seconds .

Radius Capnography wirelessly connects to Root, providing a compelling mainstream capnography solution:

  • Wireless Capnography: The wireless connection that binds the Radius Capnography sensor and the patient to root improves workflow and reduces the possibility of interrupting capnography monitoring by minimizing the pull on the breathing circuit.
  • Automated documentation: Root automates the electronic record of patient data, including data collected by radius Capnography data in electronic medical records systems (EMR) systems of hospitals and works with Masimo Patient SafetyNet ™ or iris Gateway ® together to simplify the workflow and speed up and reduce the likelihood of transcription errors. 2
  • Maximize visibility and manipulation: Root's large, high-resolution multi-touch screen provides an easily interpretable secondary display of large, crisp EtCO 2 waveforms, improves visibility, and helps clinicians identify wave patterns that indicate airway obstruction or tube displacement. Clearly displayed trend data for up to 96 hours helps clinicians review patient progress over time and control ventilation efforts. The intuitive touch screen interface allows clinicians to quickly adjust the trend display area and configure the alarm settings to suit the needs of each patient.
  • Hassle-free connectivity: Radius Capnography's wireless design and fast Bluetooth pairing provides the benefits of reliable capnography and root connectivity without the need for additional cables. This facilitates movement between the care areas as patients move through the hospital and in busy operating theaters where space is already scarce.

American Heart Association guidelines recommend, in addition to clinical assessment, continuous quantitative waveform capnography to help clinicians confirm placement of endotracheal tube 3 , assess the depth and effectiveness of chest compressions during CPR 4 , and return spontaneous circulation during the CPR detection. 4

Root is a powerful, extensible hub that integrates a variety of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. The plug-and-play expansion capabilities of Root enable physicians, simultaneously with radius Capnography and other measurements, such as the radius PPG SET ® Measure-through Motion and Low Perfusion pulse oximetry and the extended rainbow ® Pulse CO-oximetry, patient status to monitor.

Joe Kiani, founder and CEO of Masimo, said, "We are pleased to announce the second wireless sensor for Root, Radius Capnography. With this CE mark, Radius Capnography's advanced connectivity is now available both in the US and in CE-marked countries, making Masimo capnography more accessible to more hospitals worldwide. "

About Masimo

Masimo is a global medical device company that develops and produces a wide range of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitoring equipment, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce nursing costs. Masimo's pulse oximeter SET® Measure-through Motion and Low Perfusion ™ was first introduced in 1995, and over 100 independent, objective studies have shown that it outperforms other pulse oximetry technologies.  Masimo SET ® has also been proven to help clinicians reduce severe preterm neonatal retinopathy in newborns, Improve testing for CCHD in neonates  and use for continuous monitoring with Masimo Patient SafetyNet ™ at postoperative sites, reducing the activation of emergency teams, transfers to intensive care units, and reducing costs. 8-10 Masimo SET ® is used worldwide is estimated at more than 100 million patients in leading hospitals and other care area and is the main pulse oximetry in nine of the ten leading clinics in the Best Hospitals Honor Roll 2019-20 of US News and Called World Report . Masimo SET refined ®and announced in 2018 that the SpO 2 accuracy of RD-SET ® sensors has significantly improved during exercise. Clinicians can be even more confident that the SpO 2 values ??they rely on accurately reflect the physiological state of a patient. In 2005, Masimo introduced the rainbow ® pulse CO oximetry technology . In order for a non-invasive, continuous monitoring of blood constituents was made possible what previously were required invasive procedures: Hemoglobin Share (SpHb ® ), oxygen content (SPOC ™), carboxyhemoglobin (SpCO ® ), methemoglobin (SpMet ®) Plethysmography variability index (Pleth Variability Index, PVI ® ), RPVi ™ (rainbow ® PVi) and Oxygen reserve index (OR i ™). In 2013, Masimo unveiled the Root ® patient monitoring and connectivity platform . It has been designed from the ground up to be as flexible and extensible as possible so that additional monitoring technologies can be added by Masimo and other vendors. Among the important Masimo additions include Next Generation SEDLine ® -Hirnfunktionsmonitoring, O3 ® -Regionaloximetrie and ISA ™ -Kapnografie with Nomoline ® sample lines. To the Masimo family of pulse CO oximeters ®Continuous or random monitoring includes devices designed for use in a variety of clinical and non-clinical scenarios, including: strapless, wearable technologies such as Radius- 7® and Radius PPG ™, portable devices such as the Rad-67 ™, fingertip pulse oximeter such as the MightySat ® Rx and devices such as the Rad-97 ® , which are available for use in the hospital or at home. At the heart of Masimo's automation and connectivity solutions in clinics is the Iris ® platform . These include Iris Gateway ® , Patient SafetyNet, Replica ™, Halo ION ™, UniView ™ and Doctella ™. For more information about Masimo and its products, . The clinical trials published on Masimo products are available at .

ORi and RPVi are not FDA-510 (k) approved and are not for sale in the US. Use of the Patient SafetyNet trademark is licensed from the University HealthSystem Consortium.

Forward-looking statements

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo radius Capnography ™, root ® , patient SafetyNet ™, and Iris gateway ®, These forward-looking statements are based on current expectations of future events that are relevant to us and are subject to risks and uncertainties that are difficult to predict and many of which are beyond our control. Therefore, actual results may differ materially and unfavorably from those contained in our forward-looking statements due to various risk factors. These include, but are not limited to, risks associated with our assumptions about repeatability of clinical trial results; Risks associated with our belief that Masimo's unique non-invasive sensing technologies, including Masimo Radius Capnography, Root, Patient SafetyNet, and Iris Gateway, contribute to positive clinical outcomes and patient safety; Risks related to our view that Masimo's breakthrough non-invasive technologies offer cost-effective solutions and unique benefits; and other factors described in the "Risk Factors" section of our current filings with the Securities and Exchange Commission ("SEC"). These can be obtained for free on the SEC's website described in the "Risk Factors" section of our current filings with the Securities and Exchange Commission ("SEC"). These can be obtained for free on the SEC's website described in the "Risk Factors" section of our current filings with the Securities and Exchange Commission ("SEC"). These can be obtained for free on the SEC's, Although we believe that the expectations expressed in our forward-looking statements are reasonable, we do not know whether our expectations will prove to be correct. All forward-looking statements contained in this press release are expressly qualified in their entirety by the preceding warnings. You are cautioned not to unduly rely on these forward-looking statements, which are for the time being. We undertake no obligation to update, revise or detail any of these statements or the "Risk Factors" contained in our most recent reports to the SEC, whether as a result of new information, future events or otherwise, except as required by applicable securities laws ,

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Evan Lamb



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