Masimo Announces FDA 510(k) Clearance for Root® with Noninvasive Blood Pressure and Temperature
February 17, 2016 08:03 AM Eastern Standard Time
IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for noninvasive blood pressure and temperature measurements for the Root® patient monitoring and connectivity platform.
Root with noninvasive blood pressure from SunTech Medical enables clinicians to measure arterial blood pressure for adult, pediatric, and neonatal patients, with three distinct measurement modes: spot-check, automatic interval, and stat interval. The temperature module from Welch Allyn is indicated to measure the temperature of adult and pediatric patients.
With the addition of noninvasive blood pressure and temperature to the Root platform, clinicians can easily and automatically chart vital signs data directly from Root. Enhancing the solution with Masimo Patient SafetyNet™ allows data to be sent directly to the patient's electronic medical record (EMR) while alarms and alerts are seamlessly forwarded to the patient's clinician.
Root with noninvasive blood pressure and temperature provides a monitoring solution for step-down, medical, and surgical environments. Clinicians on a unit equipped with this technology are expected to be able to continuously monitor their patients and automatically document vital signs while improving workflow, allowing them to spend more time with their patients.
Root offers a high visibility display with intuitive, touchscreen navigation for easy and adaptable use in any hospital environment:
Integrates measurements from Masimo Radical-7® handheld for SET® Measure-through Motion and Low Perfusion™ pulse oximetry, continuous hemoglobin (SpHb®), PVI®, and other noninvasive rainbow® parameters, or the Radius-7™ patient-worn monitor for continuous pulse oximetry and respiration rate monitoring of mobile patients.
Flexible measurement expansion through Masimo Open Connect™ (MOC-9™), including:
ISA™ CO2 capnography for sidestream monitoring featuring Nomoline™ technology, allowing for the cost-effective use of consumables.
Additional MOC-9 modules available include measurements such as SedLine® brain function monitoring.
Automatic display of parameters, waveforms, and viewing configuration based on the clinician's presence through MyView™ technology enabled with Patient SafetyNet™ version 5000 or higher.
Optional USB barcode scanner for easy patient association.
Available roll stand for ease of transport throughout the hospital.
Built-in wireless radio allows data to be transmitted continuously during rounds.
"We are excited to bring this addition to the U.S. market," said Joe Kiani, Founder and CEO of Masimo. "We designed Root to do for patient monitoring what PCs did for computing. By creating a platform which allows third-party measurement expansion, with an intuitive user interface and network connectivity, we hope to speed up innovation while reducing the cost of monitoring, as well as potentially improving patient care and patient safety."
For more information on Root with noninvasive blood pressure and temperature, go to www.masimo.com.
@MasimoInnovates | #Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.
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's Root® with noninvasive blood pressure and temperature. 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 Root® with noninvasive blood pressure and temperature, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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.
Irene Paigah, 858-859-7001