• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Texas Medical Center Partners with Enterprise Ireland

    MMT Acquires Medical Production Technology Europe

    Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement

    Royal Philips Releases EchoNavigator 4.0 Advanced Image-Guided Therapy Solution

    Brainlab Makes Majority Acquisition of Robotic Imaging Firm medPhoton
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    BMP Medical

    Fusion Biotec Inc.

    Concise Engineering

    Cirtec Medical

    Trademark Plastics Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    BMP Medical

    Fusion Biotec Inc.

    Concise Engineering

    Cirtec Medical

    Trademark Plastics Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Clears Masimo's Neonatal RD SET Pulse Oximetry Sensors with Improved Accuracy Specifications

    Improved oxygen saturation accuracy now available for all patient populations.

    FDA Clears Masimo
    Masimo RD SET Sensors for Neonates. Image courtesy of Business Wire.
    Related CONTENT
    • Delivering the Goods: The Evolving World of Combination Products
    • Study Examines Ability of Masimo's Noninvasive, Continuous Hemoglobin to Detect Anemia Earlier
    • Masimo Gains CE Mark for Portable Real-Time Capnograph
    • FDA OKs GI Scientific's Single-Use Duodenoscope Protective Device
    • Corvia Medical, physIQ Partner for Global Phase 3 Heart Failure Clinical Trial
    Business Wire01.02.20
    Masimo announced today that RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry have received U.S. Food and Drug Administration (FDA) clearance for improved oxygen saturation (SpO2) accuracy specifications for neonatal patients (< 3 kg). The updated RD SET sensors’ SpO2 accuracy specifications have improved significantly, from 3 percent to 1.5 percent ARMS1 (at 1 standard deviation), in conditions of motion and no motion, providing clinicians with even greater confidence when monitoring the oxygenation status of neonates. With this clearance, the improved performance specifications, which were incorporated into RD SET sensors for patients > 3 kg in 2018, are now available to all patient populations in the United States.
     
    Masimo’s revolutionary SET pulse oximetry has been shown in more than 100 independent and objective studies to outperform other pulse oximetry technologies—even before the revisions that achieved the improved accuracy specifications—providing clinicians with increased sensitivity and specificity to help them make critical patient care decisions.2 Crucially for newborn health, SET has been shown to help clinicians reduce severe retinopathy of prematurity in neonates3 and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns.4-5
     
    In addition to offering improved accuracy, RD SET sensors are designed to enhance patient comfort, optimize clinician workflows, and help hospitals meet green initiatives. The sensors are lightweight and have a flat, soft cable with smooth edges, so they lie comfortably on a patient’s hand or foot. In particular, RD SET NeoPt sensors with Velaid SofTouch use little to no adhesive, facilitating quick but gentle application and repositioning on the fragile skin of newborns and pre-term babies. RD SET sensors also feature an intuitive sensor-to-cable connection, while their lightweight design results in up to 84 percent less waste and their recyclable packaging reduces storage and shipping space.
     
    Joe Kiani, Founder and CEO of Masimo, said, “We’re delighted to announce the latest result of our continued innovation in our foundational SET pulse oximetry. We have long been dedicated to helping improve the lives of neonatal, infant, and pediatric patients, and this clearance significantly furthers that mission. Thanks to our engineers and the continuing support of our customers, we’ve been able to once again raise the standard for pulse oximetry performance. Even though no one has been able to create pulse oximetry that outperforms SET, we have not allowed that to stop us from continuing our pursuit of perfecting pulse oximetry.”
     
    Masimo is a global medical technology company that develops and produces monitoring technologies, including measurements, sensors, patient monitors, and automation and connectivity solutions. Its mission is to 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.2 Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.6-8 Masimo SET is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at nine of the top 10 hospitals according to the 2019-20 U.S. News and World Report Best Hospitals Honor Roll.10 Masimo continues to refine SET and in 2018, announced that SpO2 accuracy on RD SET sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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 and Radius PPG, 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 automation and connectivity solutions are centered around the Iris platform, and include Iris Gateway, Patient SafetyNet, Replica, Halo ION, UniView, and Doctella. 
     
    ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States.
     
    References
    1 ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within ± ARMS of the reference measurements in a controlled study.
    2 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.
    3 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.
    4 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.
    5 Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
    6 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.
    7 Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
    8 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.
    9 Estimate: Masimo data on file.
    10 http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
    Related Searches
    • connectivity
    • device
    • company
    • china
    Suggested For You
    Delivering the Goods: The Evolving World of Combination Products Delivering the Goods: The Evolving World of Combination Products
    Study Examines Ability of Masimo Study Examines Ability of Masimo's Noninvasive, Continuous Hemoglobin to Detect Anemia Earlier
    Masimo Gains CE Mark for Portable Real-Time Capnograph Masimo Gains CE Mark for Portable Real-Time Capnograph
    FDA OKs GI Scientific FDA OKs GI Scientific's Single-Use Duodenoscope Protective Device
    Corvia Medical, physIQ Partner for Global Phase 3 Heart Failure Clinical Trial Corvia Medical, physIQ Partner for Global Phase 3 Heart Failure Clinical Trial
    Masimo Develops Delta cHb, HHb, and O2Hb Indices for O3 Oximetry Masimo Develops Delta cHb, HHb, and O2Hb Indices for O3 Oximetry
    Masimo Unveils Newborn Oxygenation Visualization Technology Masimo Unveils Newborn Oxygenation Visualization Technology
    OS-SiA, a Next-Gen AI-Enabled Digital Scanner, is Launched by OptraSCAN OS-SiA, a Next-Gen AI-Enabled Digital Scanner, is Launched by OptraSCAN
    Level Ex Receives Prestigious Grant Level Ex Receives Prestigious Grant
    Masimo Gains CE Mark for Neonatal Noninvasive Continuous Hemoglobin Monitoring Masimo Gains CE Mark for Neonatal Noninvasive Continuous Hemoglobin Monitoring

    Related Content

    • Contract Manufacturing | Materials | R&D & Design
      Delivering the Goods: The Evolving World of Combination Products

      Delivering the Goods: The Evolving World of Combination Products

      This extremely diverse market fosters relationships between medical device and pharmaceutical companies.
      Sam Brusco, Associate Editor 11.04.19

    • Study Examines Ability of Masimo

      Study Examines Ability of Masimo's Noninvasive, Continuous Hemoglobin to Detect Anemia Earlier

      Researchers found a mean delay in the detection of anemia.
      Business Wire 11.01.19

    • Patient Monitoring
      Masimo Gains CE Mark for Portable Real-Time Capnograph

      Masimo Gains CE Mark for Portable Real-Time Capnograph

      Radius Capnography connects with the Root Patient Monitoring and Connectivity Platform to provide seamless, tetherless mainstream capnography.
      Business Wire 10.31.19


    • Packaging & Sterilization | Surgical
      FDA OKs GI Scientific

      FDA OKs GI Scientific's Single-Use Duodenoscope Protective Device

      Provides a sterile disposable barrier to protect from patient-to-patient cross-contamination.
      Business Wire 10.25.19

    • Cardiovascular
      Corvia Medical, physIQ Partner for Global Phase 3 Heart Failure Clinical Trial

      Corvia Medical, physIQ Partner for Global Phase 3 Heart Failure Clinical Trial

      The 100-plus site trial is the first to leverage continuous multivariate wearable sensor data and artificial intelligence-based analytics.
      Business Wire 10.24.19


      Breaking News
      • Texas Medical Center Partners with Enterprise Ireland
      • MMT Acquires Medical Production Technology Europe
      • Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
      • Royal Philips Releases EchoNavigator 4.0 Advanced Image-Guided Therapy Solution
      • Brainlab Makes Majority Acquisition of Robotic Imaging Firm medPhoton
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Walgreen’s Brand Vitamins and Supplements First to Carry UL Verified Mark
      Tocotrienols May Aid Weight Loss and Cognitive Performance, Animal Study Finds
      Leaven Essential to Launch Branded Botanical Extracts to Global Markets
      Coatings World

      Latest Breaking News From Coatings World

      PPG Launches HOMAX TEX>>PRO Texture System by PPG
      New Digital Solution from Interpon Helps Customers Bring Colors to Life
      What Are You Reading?
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Texas Medical Center Partners with Enterprise Ireland
      MMT Acquires Medical Production Technology Europe
      Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Catalent Introduces UpTempo Virtuoso Platform
      Elicio Therapeutics Enters Clinical Supply Agreement with Regeneron
      Reaction Biology Expands Executive Leadership Team
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      A Look at Machine Gun Kelly's $30K Diamond Mani
      Doja Cat Rocks Glam Makeup & Nails at the Billboard Music Awards
      Maggie Q Launches Beauty Supplement
      Happi

      Latest Breaking News From Happi

      Thread Beauty Launches Vegan Lip Gloss Collection
      Lip Shimmer, Powder Sunscreen and Retinol Drive Latest Beauty Searches: Spate
      Menopause Brand Womaness Enters Ulta Beauty
      Ink World

      Latest Breaking News From Ink World

      INX to Highlight Color Perfection Program, INX University at GulfCan
      Kornit Hosts Kornit Fashion Week London 2022
      Zeller+Gmelin Launches UV-Curable and Water-Based Inkjet Inks
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Schreiner ProTech introduces new PCS solution for electric vehicle charging
      FTA and FFTA announce 2022-2023 board updates
      Bar Graphic and J&J Converting open US demo center
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Essity Wins Innovation Award at Interclean
      Weekly Recap: Ontex Confirms Possibility of Attindas Deal, Purell Launches New Wipes & More
      TSG Finishing Starts Modernization Project
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Denise Pedulla Appointed as Chief Legal Officer at Conformis
      ODT's Most-Read Stories This Week—May 14
      Steven Haddad Joins Extremity Medical as Chief Clinical Officer
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Google Cloud, Saule Technologies and Columbus Energy Begin Strategic Cooperation
      JDI Develops eLEAP, World’s First Maskless Deposition + Lithographic OLED
      Toppan Develops Temperature Logger Label for Long-Distance Transportation

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login