Archive for ‘Oximetry’

EarlySense Gets Clearance to Integrate Oximetry Device into Otherwise Contactless System

EarlySense Gets Clearance to Integrate Oximetry Device into Otherwise Contactless System

EarlySense Gets Clearance to Integrate Oximetry Device into Otherwise Contactless System

Last week at TEDMED we were excited to check out the EarlySense patient monitors that slip under the mattress and provide a completely contact-free way to continuously measure respiratory and heart rates, as well as to detect overall patient movement. Here’s our interview with CEO of the company Avner Halperin:

The EarlySense System is contact-free and continuously measures respiration rate, heart rate and patient movement, including an adjustable 6 level bed exit alarm and patient turn protocol verification.

A sensing plate described in multiple pending patent applications with an integrated piezo-electric sensor is easily placed under the mattress so the patient remains comfortable and enjoys complete freedom of movement. There are no leads or cuffs.

Using groundbreaking signal processing techniques developed on a database of over 1,000,000 patient monitoring hours, EarlySense’s Embedded Algorithmic Engine converts the patients’ cardioballistic effect, respiratory motion pattern and large body movements into accurate vital signs and movement rate monitoring.

The patent pending sensing of motion enables effective filtration of artifacts for an extremely low overall alarm rate to prevent “alarm fatigue.”

The accurate results are transmitted and displayed automatically at the bedside, nurses’ station and on additional displays in centralized areas.

The data is also sent simultaneously to handheld devices to ensure intervention of all relevant caregivers throughout the unit.

Israel based EarlySense received FDA clearance for its bedside system and central display system with oximetry integration. EarlySense’s systems are based on a contact-free sensor placed under the mattress which can monitor respiration rate, heart rate and patient movement, and now the probably wired pulse oximeter (no pics yet) can provide additional critical data.

The company is promoting the additional capabilities of the system by noting that the Joint Commission’s recent Sentinel Event Alert recommended oxygenation and ventilation monitoring in post-op patients recovering on opioids. By offering a system that can do contact-free vitals monitoring, clinical staff has one less thing to hook up to the patient, making everyone involved free to do other things.

More about the company’s technology:

EarlySense device EarlySense Gets Clearance to Integrate Oximetry Device into Otherwise Contactless System (VIDEO)

A sensing plate described in multiple pending patent applications with an integrated piezo-electric sensor is easily placed under the mattress so the patient remains comfortable and enjoys complete freedom of movement. There are no leads or cuffs.

Using groundbreaking signal processing techniques developed on a database of over 1,000,000 patient monitoring hours, EarlySense’s Embedded Algorithmic Engine converts the patients’ cardioballistic effect, respiratory motion pattern and large body movements into accurate vital signs and movement rate monitoring.

The patent pending sensing of motion enables effective filtration of artifacts for an extremely low overall alarm rate to prevent “alarm fatigue.”

The accurate results are transmitted and displayed automatically at the bedside, nurses’ station and on additional displays in centralized areas.

The data is also sent simultaneously to handheld devices to ensure intervention of all relevant caregivers throughout the unit.

Source : http://www.earlysense.com/01/technology-platform/

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Masimo Universal ReSposable Pulse Oximetry Sensor System

Masimo Universal ReSposable Pulse Oximetry Sensor System

Masimo Universal ReSposable Pulse Oximetry Sensor System

Masimo to Report Third Quarter 2012 Financial Results after Market Close on October 30 Conference call and webcast to begin at 1:30 p.m. PT (4:30 p.m. ET)

IRVINE, Calif., October 16, 2012 — Masimo (NASDAQ: MASI) announced today that it will release third quarter financial results for the period ended September 29, 2012, after the market closes on October 30, 2012. The conference call to review the results will begin at 1:30 p.m. PT (4:30 p.m. ET) and will be hosted by Joe Kiani, Chairman and Chief Executive Officer, and Mark P. de Raad, Executive Vice President and Chief Financial Officer.

A live webcast of the conference call will be available online from the investor relations page of the company’s corporate website at www.masimo.com. The dial-in numbers are (888) 520-7182 for domestic callers and +1 (706) 758-3929 for international callers. The reservation code for both dial-in numbers is 38439591. After the live webcast, the call will be available on Masimo’s website through November 30, 2012. In addition, a telephonic replay of the call will be available through November 13, 2012. The replay dial-in numbers are (800) 585-8367 for domestic callers and +1 (855) 859-2056 for international callers. Please use reservation code 38439591.

About Masimo

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 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, Masimo introduced 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. And in 2012, Masimo acquired the assets of Spire Semiconductor, LLC, maker of advanced light emitting diode (LED) and other advanced component-level technologies; and PHASEIN AB, a developer and manufacturer of ultra-compact mainstream and sidestream capnography, multigas analyzers, and handheld capnometry solutions. Masimo SET® and Masimo rainbow® SET® technologies also can 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.

Contact:

Sheree Aronson

(949) 297-7043

saronson@masimo.com

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, and SEDLine are trademarks or registered trademarks of Masimo Corporation.

Irvine, California – October 15, 2012 – Masimo (NASDAQ: MASI) announced today limited market release of the Universal ReSposable™ Pulse Oximetry Sensor System, offering the Measure-Through Motion and Low Perfusion performance and accuracy of SET®, as well as the comfort of its single-patient-use adhesive sensors with the cost-effectiveness and environmental advantages of a reusable sensor.

The new Universal ReSposable pulse oximetry sensor was created after more than 10 years of research and development with feedback from hundreds of clinicians on what they wanted most in a sensor – less waste, more value, and the Masimo SET® performance.

The new ReSposable sensor components sit atop the sensor – not embedded – reducing risk of pressure points. Patients also can be disconnected from a pulse oximeter without having to carry the sensor cable.

“We’ve been impressed not only with the reduction in costs, but the ReSposable sensor is helping us meet our environmental, waste-reduction goals,” said SuzAnne J Gil, Clinical Resource Manager at San Juan Regional Medical Center in Farmington, New Mexico. “In an era when hospitals are expected to deliver quality care, while controlling costs and carbon footprints, Masimo’s ReSposable sensors offer a clear benefit for patients, clinicians and facility administrators.”

“The Masimo innovative ReSposable concept should be considered for any clinical unit regarding SpO2 sensor usage because of its sustainability both in terms of cost-control and waste-reduction policies,” said Dr. Concha Go?i, head of neonatal and pediatric intensive care units at Hospital Virgen del Camino in Pamplona, Spain, where the sensor has been used as part of Masimo’s pre-market release testing.

Masimo’s Universal ReSposable SpO2 sensors generate up to 90% less waste vs. 34% less waste with reprocessing,* while reducing carbon emissions up to 41% vs. 43% more emissions with reprocessing.**

Disposable pulse oximetry sensors historically have offered the best performance, greatest ease of use, and most comfort, but do generate more waste than reusable sensors. Reusable sensors may offer low environmental impact, but do not offer the same performance, comfort, or reduction of cross-contamination risk as disposable sensors. And third-party reprocessed sensors do not offer the same performance or quality as new sensors, as evidenced by their own indications for use statements. Moreover, reprocessed sensors have a higher carbon footprint than new sensors, due to greater greenhouse gas emissions from transport, reprocessing, and decontamination procedures.

Joe Kiani, CEO and Founder of Masimo, said, “More than ever, hospitals are under pressure to reduce costs and implement green initiatives, while maintaining infection-control practices to protect patients and staff from cross-contamination. While the ultimate way to reduce cost and improve care is through process of care improvements made possible by technologies like SET® and rainbow®, with ReSposable sensors, hospital materials management departments can meet the cost reduction edicts, while helping their hospitals meet their environmental, and safety goals, and most importantly ensure that their patients are provided with accurate monitoring when they need it most.”

Contact your local Masimo sales representative for demonstration of the Universal ReSposable Sensors. To locate a Masimo representative or distributor in your area and evaluate the Universal ReSposable SpO2 Sensor System, call 1-800-257-3810 or visit www.masimo.com.

*Waste calculated by sensor weight for 40% reprocessed sensors with a mix of 80% Adult and Pediatric sensors, 20% Neo and infant sensors.

**Carbon footprint comparisons calculated by lbs. CO2 emissions with same reprocess mix as waste. Carbon footprint calculations validated by Carbonfund.org in November, 2011.

About Masimo

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.

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 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 of the repeatability of clinical results obtained using the Universal ReSposable SpO2 Sensor System, the comfort of the single-patient-use adhesive sensor, its cost-effectiveness, and environmental advantages; and our assumptions that rainbow Universal SuperSensor enables continuous measurement of SpHb, SpCO, SpMet, SpO2 and the new SpfO2 parameter that allows precise oxygen saturation even in the presence of dyshemoglobins, 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.

Irvine, California – October 9, 2012 – 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.

CAPTION: Masimo’s new FDA-Cleared uSpO2™ cable (right) provides plug-and-play Masimo SET® pulse oximetry functionality with GE’s ApexPro® Telemetry Systems (left).

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.

About Masimo

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.

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 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.

Source : http://www.masimo.com/news/index.cfm#3426

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