GE Healthcare Integrates New FDA-Cleared Masimo SET® uSpO2™ Pulse Oximetry Cable into GE's ApexPro® Telemetry Systems
IRVINE, Calif., Oct. 9, 2012 /PRNewswire/ -- Masimo (NASDAQ: MASI) today announced the FDA 510(k) clearance and market release of Masimo's new uSpO2™ universal pulse oximetry cable for use with GE Healthcare's ApexPro® Telemetry Systems. GE Healthcare is the first to integrate Masimo's low power platform with SET® Measure-Through Motion and Low Perfusion SpO2 technology into patient-worn monitors designed for use in ambulatory patient care environments.
Ambulatory care environments such as telemetry and cardiac step-down units often use patient-worn monitors to conduct continuous monitoring during patient ambulation. In addition to the motion artifact caused by this ambulation, cardiac patients can experience low peripheral perfusion on an intermittent or consistent basis. However, these monitoring conditions have proven to be particularly challenging for conventional pulse oximetry technology and may lead to inaccurate pulse oximetry measurements and nuisance alarms that detract from patient care.1 As demonstrated in more than 100 independent and objective studies, Masimo SET® pulse oximetry is clinically proven to virtually eliminate false alarms1 and increase a clinician's ability to detect life-threatening events2 under challenging conditions including patient motion and low peripheral perfusion.
Masimo's uSpO2™ (pictured) is a "Board-in-Cable" external pulse oximetry solution that provides a simple way to add Masimo SET® pulse oximetry for devices that are not designed to have SpO2 integrated inside the device. The uSpO2™ cable embeds a Masimo MS-2040 circuit board within a completely self-contained cable that attaches to the patient sensor.
The uSpO2™ cable adapted for the GE ApexPro® Telemetry Systems provides full Masimo SET® pulse oximetry capabilities with proven accuracy during patient motion and low perfusion, while reducing Masimo's power consumption to approximately 60 milliwatts, which reflects a 97% reduction to initial SET® SpO2 platforms and a 52% reduction vs current SET® platforms.
Masimo's new uSpO2™ cable has been adapted to provide plug-and-play functionality with GE's ApexPro® Telemetry Systems. As a result, clinicians can upgrade their monitoring capabilities by purchasing Masimo's uSpO2™ cable for their GE ApexPro Telemetry System – without the cost of additional hardware or software. And for the hundreds of GE customers who have standardized on Masimo SET® SpO2 technology within their GE bedside monitors, the uSpO2™ cable enables standardization of SpO2 technology and sensors as patients transition between care areas—from bedside monitors in hospital rooms to patient-worn transmitters in ambulatory care areas. This measurement technology and sensor standardization can help healthcare providers reduce costs, while enhancing workflow, care processes, and efficiencies.
Today's announcement builds on a long-term existing partnership between GE Healthcare and Masimo. Earlier this year, GE Healthcare and Masimo jointly announced an expanded long-term agreement under which GE Healthcare would incorporate Masimo rainbow® SET® technology into many of GE Healthcare's patient monitoring products.
Rick Fishel, Masimo President of Worldwide OEM Business and Corporate Development, stated, "Masimo is focused on delivering innovative technology solutions that allow caregivers to better address the needs of their patients under the most challenging environments. We are pleased that GE Healthcare is the first patient monitoring company to combine Masimo's low power SET® technologies in ambulatory patient applications, further enhancing GE's comprehensive wireless solutions that enable caregivers to work more productively and respond to critical situations faster. We believe this new level of functionality in GE's patient-wearable monitors capitalizes on our technology partnership and reflects our shared corporate visions to improve patient outcomes while reducing the cost of healthcare delivery."
1 Shah N, Ragaswamy H, Govindugari K, Estanol L. "Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers." Journal of Clinical Anesthesia. 2012 (10.1016/j.jclinane.2011.10.012) Available online here.
2 Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2. Available online here.
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms all other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, the company introduced Masimo Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET® technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET® and Masimo rainbow SET® technologies can also be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care … by Taking Noninvasive Monitoring to New Sites and Applications®." 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 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 that the reduced power consumption profile stated for the uSpO2 for GE ApexPro will be consistent for other telemetry systems; that the uSpO2 delivers a new level of functionality in GE's patient-wearable monitors that will help to improve patient outcomes while reducing the cost of healthcare delivery; and that uSpO2 will facilitate measurement technology and sensor standardization that can help healthcare providers reduce costs, while enhancing workflow, care processes, and efficiencies; 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, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care… by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.