Royal Philips announced FDA clearance allowing the activation of SedLine® Brain Function Monitoring, Regional Oximetry, and CO2 measurements in Philips Patient Monitors – IntelliVue MX750 and MX850.
Amsterdam, the Netherlands and Irvine, California, U.S. – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Masimo (NASDAQ: MASI), a global medical technology company, today announced FDA clearance allowing the activation of SedLine® Brain Function Monitoring, Regional Oximetry (O3®), and CO2 measurements in Philips Patient Monitors – IntelliVue MX750 and MX850. The latest extension of Masimo and Philips’ ongoing collaboration will help enable clinicians to make quick and informed decisions without the need for additional monitoring equipment.
Integrating the SedLine, O3® and CO2 advanced Masimo measurements into Philips high acuity IntelliVue® MX series multi-parameter monitors can help clinicians assess and monitor blood saturation in the brain (cerebral oxygenation), anesthetic sedation, and patient respiratory performance with ease, all from the same monitor. The data can also be shared between monitors. These capabilities and metrics help care providers to act decisively while also helping to lower cost of care by providing a more holistic view of the patient from one system.
“Our work with Masimo has enabled us to forge new paths in continuous monitoring,” said Christoph Pedain, General Manager, Hospital Patient Monitoring at Philips. “We’re connecting data and technologies to help arm care providers with the robust information they need to make timely, informed care decisions for their patients.”
“Combining our expertise in noninvasive monitoring and signal processing technologies with Philips’ expertise in integrated patient monitoring and therapy solutions is a win-win for patients and clinicians alike,” said Jon Coleman, President of Worldwide OEM Sales and Global Health, Masimo. “We are proud that Philips has chosen to make our innovative SedLine, O3, and NomoLine technologies available to their customers. We look forward to continuing our partnership with a focus on improving patient outcomes and reducing the cost of care.”
Since establishing a partnership to improve patient care, outcomes and safety in 2016, Philips and Masimo have already introduced a variety of advanced monitoring capabilities to select IntelliVue® MX-series multi-parameter monitors. Today’s announcement reveals the expansion of O3 regional oximetry capability to Philips’ latest, high acuity MX750 and MX850 patient monitors, as well as the introduction of new SedLine Brain Function Monitoring and CO2 measurement capabilities, adding versatility to Philips’ already robust portfolio of patient monitoring solutions that support clinical workflow, caregiver efficiencies, and enhanced patient care. To learn more about Philips’ ongoing collaboration with Masimo to deliver on the future of continuous monitoring, visit www.philips.com/masimo.
For further information, please contact:
Meredith Amoroso
Philips Global Press Office
Tel. : +1 724-584-8991
E-mail : meredith.amoroso@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2022 sales of EUR 17.8 billion and employs approximately 74,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
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. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, 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 newborns3 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 as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.9 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®, Radius PPG®, and Radius VSM™, 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 and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Its growing portfolio of health and wellness solutions includes Radius Tº® and the Masimo W1™ watch. 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, RPVi, and Radius VSM 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.
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.
Attachments
- Masimo CO2, O3 and Sedline measurements are now available on Philips high acuity MX750 & MX850 IntelliVue monitors
- Philips patient monitors MX750 and MX850 in an operating room
