Masimo Announces CE Marking of Pediatric Indication for Next Generation SedLine® Brain Function Monitoring
Masimo (NASDAQ: MASI) announced today the CE marking of Next Generation SedLine® brain function monitoring for pediatric patients (1-18 years of age). With this clearance, the benefits of Next Generation SedLine are available for all patients one year old and above in CE mark countries. SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral data acquisition and processing of four leads of electroencephalogram (EEG) signals.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190304005383/en/
Masimo Root® with Next Generation SedLine® (Photo: Business Wire)
SedLine uses a pediatric-specific signal processing engine to improve performance of Masimo’s processed EEG parameter, the Patient State Index (PSi), when monitoring pediatric patients one year old and above. The use and monitoring of anesthesia on pediatric patients can differ from its use on adults.1-2 Maintaining an appropriate level of anesthesia is key to preventing anesthesia-related events and enabling faster recovery.3 The PSi in SedLine, driven by its pediatric-specific engine, is uniquely suited to helping clinicians interpret the EEGs of this challenging population.
In addition to the newly announced pediatric-specific signal processing when used on pediatric patients, Next Generation SedLine offers significant improvements over original SedLine, including:
- A PSi with less susceptibility to electromyography (EMG) interference.
- A Multitaper Density Spectral Array (DSA), which may enhance visibility of EEG features.
Joe Kiani, Founder and CEO of Masimo, said, “Next Generation SedLine is doing for brain function monitoring what Masimo SET® did for pulse oximetry. We believe Next Generation SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging brains are appropriately anesthetized. We are gratified that its benefits are now available to those younger patients whose brains are particularly delicate and to whose wellbeing Masimo has always been so committed.”
Next Generation SedLine has received FDA clearance for adults but is not currently indicated for pediatric patients in the USA.
@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. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.4 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,5 improve CCHD screening in newborns,6 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.7-9 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,10 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.11 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®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect® (MOC-9®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor, iSpO2 ® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
- Davidson et. Current Anesthesiology Reports 3. 1 (2013): 57-63.).
- Cornelissen L et al. Elife 4 (2015): e06513.
- Musialowicz et al. Current Anesthesiology Reports 4. 3 (2014): 251-260.
- 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
- 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.
- 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.
- Taenzer AH 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.
- Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
- McGrath SP 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.
- Estimate: Masimo data on file.
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 SedLine® and Next Generation SedLine. 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 SedLine and Next Generation SedLine, 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; 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.
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn’s Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)14.2.2020 07:00:00 CET | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn’s disease (CD) achieved clinical responsea and 67 percent were in clinical remissionb after receiving one ~6 mg/kg intravenous (IV) dose followed by one 90 mg subcutaneous (SC) dose of STELARA® (ustekinumab), open label.1 Intestinal ultrasound (IUS) responses were assessed and were detected as early as week 4.2 Week 16 data (digital oral presentation or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as part of a digital oral presentation at the 15th Congress of the European Crohn’s & Colitis Organisation (ECCO).1,2 The primary endpoint of the 48-week STARDUST study is comparative endoscopic responsec among adult patients with CD receiving ustekinumab maintenance therapy.3 At week 16, patients who achieved a ≥70 point decrease in Crohn’s Disease Activity Index scored
Edwards Launches New Compact Dry Vacuum Pump With the Highest Pumping Density on the Market13.2.2020 13:07:00 CET | Press release
Edwards launch the new nXRi high performance compact dry pump, with lower input power and zero maintenance, bringing real performance improvements and cost benefits across a range of applications. Initial variants will provide pumping speeds of either 60 and 90 m3h-1 , four times more pumping speed than a similar sized dry pump. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200213005447/en/ Edward nXRi Compact Dry Vacuum Pump (Photo: Business Wire) Designed with size in mind, the compact footprint and height allow the Edwards nXRi dry pump to fit easily under a benchtop saving valuable space in the laboratory; and at under 30kg offers a highly mobile vacuum pump for changing work flows and environments. The pump is maintenance free for up to five years, with no tip-seal or oil change, for maximum uptime and reduced maintenance costs. The nXRi's 40% smaller footprint, compared to alternative dry pumps, assures seamless integ
Interactive Brokers Launches Bond Scanner to Help Investors Find the Best Pricing on Wide Range of Fixed Income Products12.2.2020 15:00:00 CET | Press release
Interactive Brokers Group, Inc. (Nasdaq: IBKR) today announced it has created a Bond Scanner to help make finding the best prices on bonds easier and more transparent for clients and non-clients alike. “We believe we offer the lowest bond prices available. Investors should visit our Bond Scanner at ibkr.com/bonds, filter for bonds of interest, and then call their broker to compare,” said Steven Sanders, EVP of Marketing and Product Development at Interactive Brokers. “Clients benefit from our aggregation of price quotes from multiple electronic venues and institutional dealers,” he added. “We do not widen spreads nor are there hidden fees or markups. While some companies charge a large, hidden markup, we charge extremely low, transparent commissions. IBKR clients may provide liquidity to bond markets and improve pricing by entering their own pending orders into the book.” In addition to ultra-low, transparent pricing, the company offers a huge selection of fixed income products, includ
ADVA tackles GNSS jamming and spoofing with market’s first intelligent assurance solution11.2.2020 08:00:00 CET | Press release
ADVA (FSE: ADV) today launched the industry’s first centralized GNSS monitoring and assurance tool. Using artificial intelligence (AI) and machine learning (ML) for comprehensive predictive maintenance, it addresses the key concerns of GNSS users around the globe. The new customer-owned tool enables users to collect and analyze huge amounts of information from across the network to remotely identify issues and protect networks from GNSS vulnerabilities, including jamming and spoofing attacks. It also helps to identify GNSS obstruction issues, detect blind/poor spots that appear over time and enable optimal antenna positioning. Built into ADVA’s Ensemble Controller network management suite with Sync Director, the solution enables customers to detect potential problems in advance, maintain the highest quality of network synchronization and significantly reduce opex. By complementing today’s limited distributed approach to GNSS assurance with a centralized-global system, it offers a major
Light Up the Future with Posiflex at EuroShop 202011.2.2020 02:12:00 CET | Press release
The Posiflex Group, a synergy of world-leading POS, kiosk, and industrial computing technologies — will bring its Serviced IoT solutions to EuroShop 2020, the leading Europe trade fair for the retail industry, from February 16th – 20th at Hall6/A57 in Düsseldorf. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200210005879/en/ Mini Kiosk - Mercury EK-Series (Photo: Business Wire) Nowadays, the ways of retail have been fundamentally changed. Retailers are experiencing unparalleled disruption and are facing new challenges with fierce competition and consumer demands. To aid retailers to stay ahead of the curve, Posiflex POS solutions help retailers to become an integral part of the future retail by offering machines with advanced capabilities, such as rotating screens, various OS platform support, hands-on cable management, and ease of service. Posiflex’s new Android version of MT-Series (Mobile POS), RT-Series (POS terminal),
Global Market Leader Fiat Chrysler Automobiles Selects IDEMIA’s Connectivity Solutions to Improve the Connected Vehicle Experience10.2.2020 07:49:00 CET | Press release
FCA takes its forward-thinking global telematics program to the next level with the integration of IDEMIA’s eSIM (DAKOTA) and Subscription Manager platform (Smart Connect). These groundbreaking services, already operational, are enabling each day FCA to optimize vehicle operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200209005062/en/ (Photo: Business Wire) The DAKOTA eSIM will be embedded directly into new FCA vehicle models that will be launched in multiple regions. Combined with Smart Connect, this solution gives the automaker the flexibility to dynamically choose the best connectivity provider throughout the lifetime of the vehicle on a worldwide scale. IDEMIA’s solutions not only pave the way for in-demand services such as emergency calls, predictive maintenance and insurance-related services, but also simplify the manufacturing process and provide the capability to remotely update software and tailor connecti