Masimo Announces the iSirona™ Connectivity Hub

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced the global launch of iSirona^™, a compact, versatile connectivity hub designed to maximize interoperability across the continuum of care. The iSirona hub offers an efficient way to physically connect up to six medical devices at the bedside and automatically route the data to the Masimo Hospital Automation^™ platform, a vendor-agnostic connectivity solution for EMR integration, surveillance monitoring, alarm management, mobile notifications, smart displays, and analytics. Supplemented by iSirona, Masimo Root^®—a powerful, versatile, multimodal patient monitoring and connectivity solution combining numerous advanced measurements with sophisticated expansion capabilities—helps ensure that whatever the source, all patient data can be accurately and efficiently captured and presented to clinicians in the most suitable ways.

iSirona, Root, and the Hospital Automation platform are already compatible with an ever growing list of more than 500 medical devices. With its focus on versatility and compatibility, iSirona is particularly valuable as an easy but robust way for hospitals to connect almost all medical devices, regardless of brand—helping reduce the time spent manually charting patient data and instances of transcription errors, while promoting efficient workflows by giving clinicians access to patient data wherever, whenever, and however they want to see it.

With its compact and fan-less design, iSirona is ideal for connecting multiple patient monitors, anesthesia machines, pumps, and other medical devices in operating rooms and ICUs where space is often restricted. The included multi-slotted mounting bracket allows iSirona to be fixed in a room or mounted directly to a mobile medical device (such as a ventilator) to provide connectivity wherever the medical device is used. The onboard rechargeable battery and local storage allow the iSirona to continue operating and buffering data for up to two hours in the event of a power outage or loss of network connectivity, helping reduce potential loss of data during emergencies and ensuring data continuity during patient transport. With software-configurable USB and Bluetooth^® connections, iSirona is designed to integrate today’s physical medical devices and support wireless and wearable devices in the future, as well as provide utility in both high- and low-acuity areas throughout the hospital.

In addition to iSirona and Root, the Hospital Automation platform encompasses a variety of components that together provide a holistic, end-to-end hospital data automation solution that aggregates high-fidelity parametric data, waveforms, and alarms from Masimo and third-party devices. For example, clinicians can surveil and remotely monitor patients from a central location, as well as view alarms, using Masimo Patient SafetyNet™. With Masimo Replica™, real-time monitoring data and alarm notifications can be relayed to mobile devices, reaching clinicians wherever they are—even beyond the hospital. Masimo UniView™ brings together data from multiple devices on an enlarged display that can be tailored for each patient case, helping ensure that data is visualized for clinical teams as usefully as possible. And Masimo Iris Analytics™ transforms data into richly detailed, customizable patient and even hospital-wide reports.

Joe Kiani, Founder and CEO of Masimo, said, “We believe that Masimo’s Hospital Automation platform is the most customizable, versatile, and future-focused connectivity solution on the market. We continue to deepen our understanding of what data clinicians most want to have at their fingertips and how, in the ideal hospital of tomorrow, it will be available to them—and to develop monitoring, display, automation, notification, and reporting solutions that best address these needs now. iSirona, the latest member of the Hospital Automation family, makes it easier than ever to add connectivity wherever it’s needed—bringing offline data online, smoothing workflows, and ultimately, helping clinicians improve patient care.”

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.⁹ Masimo continues to refine SET^® and in 2018, announced that SpO₂ accuracy on RD SET^® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^® and Radius PPG™, portable devices like Rad-67™, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris Gateway^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo iSirona^™, Hospital Automation™, and Root^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo iSirona, Hospital Automation, and Root, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Masimo
Evan Lamb
949-396-3376
elamb@masimo.com