• 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
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    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
    Top News
    CMS Establishes New Payment for Pelvalon’s Eclipse System

    Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy

    Resonetics Leases New Manufacturing Space in Costa Rica

    Seisa Medical Acquires ProtoQuick and Peridot

    Masimo Device is Useful in Assessing Respiratory Status of Pediatric Tracheostomy Patients
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Home Is Where the Heart (Valve) Is

    CGM: Digital Health Meets a Very Large Opportunity

    Biomechanical Engineer, Heal Thyself

    Optimizing MIM in Medical Device Manufacturing

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    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
    PTI Engineered Plastics Inc.

    Medicoil

    Spectrum Plastics Group

    Unicep

    Creganna Medical, part of TE Connectivity
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Three Future Trends and Opportunities in Quality Assurance

    Adopting a Data-Driven Quality Model

    Digital Transformation for Quality and Manufacturing

    Digging into the Cardiac Arrhythmia Monitoring Device Market

    EMS Providers Supplying More Than Electronics to Customers
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    FUTEK Advanced Sensor Technology Inc.

    Spectrum Plastics Group

    K-Tube Technologies

    Concise Engineering
    • 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
    • Podcasts
    • Resources
    • eBook
    • 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 OKs Neonatal Indication for Masimo's O3 Regional Oximetry

    The benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults.

    FDA OKs Neonatal Indication for Masimo
    Masimo Root with O3 Regional Oximetry. Image courtesy of Business Wire.
    Related CONTENT
    • Digging into the Cardiac Arrhythmia Monitoring Device Market
    • Four Considerations When Selling to a Private Equity Fund
    • Neurolief's Brain Neuromodulation Technology Cleared by FDA for Migraine Treatment
    • Optellum Receives FDA Clearance for Virtual Nodule Clinic
    • FDA Clears Rhythmlink's New MR Conditional Electrode Portfolio
    Business Wire06.10.19
    Masimo announced that O3 Regional Oximetry has received FDA clearance for use on neonatal and infant patients (<10 kg). O3 may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With this expansion of the O3 platform, the benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults.
     
    O3, which uses near-infrared spectroscopy (NIRS) to monitor the regional hemoglobin oxygen saturation of blood (rSO2) on both sides of the brain, may be particularly helpful in providing insight into neonatal patient status because neonatal pathology is often brain-related.1 In neonates, O3 provides reliable measurement with a 3 percent ARMS* trending accuracy specification.
     
    O3 sensors are available in three sizes, for adult (≥40 kg), pediatric (≥5 kg and <40 kg) and now infant and neonatal (<10 kg) patients. With its smaller size and flexible design, the neonatal sensor is designed to fit easily and comfortably on the delicate foreheads of tiny patients.
     
    O3 is available as a Masimo Open Connect (MOC-9) module for the Root Patient Monitoring and Connectivity Platform. Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with O3 and other measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry, providing clinicians with expanded visibility of neonatal oxygenation status. Additional modalities available on Root include advanced rainbow noninvasive measurements such as total hemoglobin (SpHb), SedLine brain function monitoring (available for adult patients), NomoLine capnography, and more – all via an easy-to-interpret, customizable display. Using Root in combination with Masimo Patient SafetyNet or Iris Gateway, monitoring data from O3 can be automatically charted in electronic medical records (EMRs).
     
    Joe Kiani, Founder and CEO of Masimo, said, “From our inception, we have been committed to improving outcomes for the youngest and most fragile patients. Our foundational SET pulse oximetry was designed with neonates and infants in mind. These patients were not an afterthought. This focus has paid off for these young patients: SET pulse oximetry has helped clinicians reduce the incidence of severe retinopathy of prematurity (ROP) in neonates2 and improve critical congenital heart disease (CCHD) screening in newborns.3 O3 Regional Oximetry, with its ability to help clinicians accurately track cerebral oxygen saturation, will hopefully have a similar impact. We are happy to be able to bring O3’s advanced capabilities and accuracy to the neonatal patient population.”
    Related Searches
    • technologies
    • fda clearance
    • design
    • patient monitoring
    Related Knowledge Center
    • Patient Monitoring
    Suggested For You
    Digging into the Cardiac Arrhythmia Monitoring Device Market Digging into the Cardiac Arrhythmia Monitoring Device Market
    Four Considerations When Selling to a Private Equity Fund Four Considerations When Selling to a Private Equity Fund
    Neurolief Neurolief's Brain Neuromodulation Technology Cleared by FDA for Migraine Treatment
    Optellum Receives FDA Clearance for Virtual Nodule Clinic Optellum Receives FDA Clearance for Virtual Nodule Clinic
    FDA Clears Rhythmlink FDA Clears Rhythmlink's New MR Conditional Electrode Portfolio
    FDA Clears Ava Fertility Tracking Wearable Device FDA Clears Ava Fertility Tracking Wearable Device
    FDA Green Lights EPI FDA Green Lights EPI's EndoClot Hemostat to Manage GI Bleeding
    FDA Clears B-Secur FDA Clears B-Secur's HeartKey EKG/ECG Technology
    FDA Clears Pulse Biosciences FDA Clears Pulse Biosciences' CellFX System
    FDA OKs CLEW FDA OKs CLEW's AI-Based ICU Predictive Analytics Tech
    Endo Tools Therapeutics Secures 8 Million Euros in Series D Funding Endo Tools Therapeutics Secures 8 Million Euros in Series D Funding
    FDA OKs Canon Medical FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    Eitan Medical Receives FDA Clearance for Sapphire Infusion System Eitan Medical Receives FDA Clearance for Sapphire Infusion System
    Quantitative Transmission Ultrasound Outperforms Mammography Quantitative Transmission Ultrasound Outperforms Mammography
    BioSerenity Achieves FDA Clearance for Wearable Device System BioSerenity Achieves FDA Clearance for Wearable Device System

    Related Breaking News

    • Chronic Disease | Digital Health | Patient Monitoring
      Welldoc, Dexcom Expand Strategic Partnership for Diabetes Management

      Welldoc, Dexcom Expand Strategic Partnership for Diabetes Management

      Companies to integrate CGM, lifestyle management platforms to offer integrated type 2 diabetes solution.
      Sam Brusco, Associate Editor 04.05.21

    • Cardiovascular | Patient Monitoring
      GE Healthcare Reveals Venue Fit POC Ultrasound with Cardiac AI Tool

      GE Healthcare Reveals Venue Fit POC Ultrasound with Cardiac AI Tool

      AI tool continuously calculates the heart’s real-time ejection fraction.
      Sam Brusco, Associate Editor 03.31.21

    • Neurological | Patient Monitoring
      FDA OKs Brain Scientific

      FDA OKs Brain Scientific's Next-Gen NeuroCap EEG Headset

      NeuroCap's advanced EEG electrode array obtains rapid EEGs in routine clinical and research settings.
      Sam Brusco, Associate Editor 03.10.21


    • Digital Health | Patient Monitoring
      Masimo Launches Tool to Support Reopening Schools, Businesses

      Masimo Launches Tool to Support Reopening Schools, Businesses

      Masimo SafetyNet-OPEN helps screen, trace, and manage users as they face COVID-19 and other infectious illnesses.
      Sam Brusco, Associate Editor 02.16.21

    • Digital Health | Patient Monitoring | Software & IT
      FDA OKs CLEW

      FDA OKs CLEW's AI-Based ICU Predictive Analytics Tech

      CLEWICU predicts hemodynamic instability in adult patients.
      Sam Brusco, Associate Editor 02.04.21

    • Digital Health | Patient Monitoring
      Philips Inks Connected Care Solutions Deal with 28-Hospital Dutch SAZ Group

      Philips Inks Connected Care Solutions Deal with 28-Hospital Dutch SAZ Group

      Different SAZ hospitals will start with Philips solutions for patient monitoring and self-management.
      Sam Brusco, Associate Editor 02.04.21


    • Patient Monitoring
      Hillrom Buys EarlySense

      Hillrom Buys EarlySense's Contact-Free Continuous Monitoring Tech

      EarlySense's contact-free continuous monitoring, analytics tech was integrated into the Centrella Smart+ med-surg bed.
      Sam Brusco, Associate Editor 02.01.21

    • Cardiovascular | Patient Monitoring
      Hillrom to Buy Bardy Diagnostics for $375M

      Hillrom to Buy Bardy Diagnostics for $375M

      Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.
      PR Newswire 01.19.21

    • Patient Monitoring
      Valencell Launches Blood Pressure Monitoring Tech

      Valencell Launches Blood Pressure Monitoring Tech

      New technology can be built into a myriad of devices to provide accurate blood pressure readings.
      Valencell 01.13.21


    • Chronic Disease | Digital Health | Patient Monitoring
      Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

      Teladoc Health, Dexcom Launch CGM Tech, Personalized Insights for Type 2 Diabetes

      CGM-powered insights offer complete health profile, recommendations that support ongoing diabetes management.
      GlobeNewswire 01.13.21

    • Patient Monitoring
      Unique Contact Lens Sensor System & Manufacturing Process Developed

      Unique Contact Lens Sensor System & Manufacturing Process Developed

      New multifunctional lens can provide diversified signals from eyes.
      Surrey University 01.12.21

    • Patient Monitoring
      Itamar Medical Acquires Spry Health Tech, Assets

      Itamar Medical Acquires Spry Health Tech, Assets

      Leverages Spry’s technology to bring to market first device for continuous remote patient monitoring of sleep apnea.
      GlobeNewswire 01.12.21


    • Patient Monitoring
      CES News: Philips Highlights Healthcare at Home

      CES News: Philips Highlights Healthcare at Home

      Participates in the first-ever all-digital CES 2021.
      Royal Philips 01.11.21

    • Patient Monitoring

      'Smart Ring' Could Spot a Fever Before You Feel It

      Advance could pave the way for early warning system on COVID-19 and flu using wearables.
      University of California - San Diego 12.14.20

    • Cardiovascular | Patient Monitoring
      FDA OKs Volta Medical

      FDA OKs Volta Medical's VX1 AI AFib Mapping Software

      Assists in real-time manual annotation of 3D anatomical, electrical maps of the atria during AFib.
      PR Newswire 12.10.20


    Trending
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Face Mask Filters 98 Percent Of COVID-19 Particles
    • Cheetah Medical Introduces Noninvasive Monitoring System
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • CMS Establishes New Payment for Pelvalon’s Eclipse System
    • Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy
    • Resonetics Leases New Manufacturing Space in Costa Rica
    • Seisa Medical Acquires ProtoQuick and Peridot
    • Masimo Device is Useful in Assessing Respiratory Status of Pediatric Tracheostomy Patients
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Transporting Treatment: An Examination of Tubing Technologies
    • Face to (Virtual) Face: Telemedicine Now and Post-Pandemic
    • Outward Appearance: Reviewing Surface Treatment Options
    • View More >

    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

    Kyowa Hakko Launches Heat-Treated Probiotic Strain for Eye Health
    CGA-7 Green Coffee Extract by Vidya Herbs Achieves Self-Affirmed GRAS Status
    Nutritional Complex Evidenced to Reduce Preterm Birth
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies to Sponsor and Exhibit at the North American Pultrusion Conference 2021
    Barentz Expands Canadian CASE Team
    Shepherd Color Company Opens Sales Office in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    CMS Establishes New Payment for Pelvalon’s Eclipse System
    Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy
    Resonetics Leases New Manufacturing Space in Costa Rica
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ
    Ascendia Pharmaceuticals Poised for Expansion
    Bora Pharmaceuticals Adds Roller Compaction Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Revlon Unveils New Fragrances Featuring Megan Thee Stallion & Sofia Carson
    Henkel Management Board Welcomes Wolfgang König
    Mielle Organics Gets a Major Investment
    Happi

    Latest Breaking News From Happi

    Nature’s Beauty Debuts Vegan Natural Body Care at Walgreens
    Estée Lauder Expands Beautiful Fragrance Collection
    The Honest Company Files for IPO
    Ink World

    Latest Breaking News From Ink World

    SE-DA Invests in Kornit Presto S
    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    Iron Oxide Pigments Market to Register 4.7% CAGR from 2021 to 2028: GVR
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Dantex elevates Joseph Sanchez to digital business development manager
    Mactac's Kevin Clunie joins TLMI panel
    MacDermid announces two new global sales roles
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Precision Textiles Offers Biodegradable Medical Fabric
    Northshore Launches Megamax Briefs in New Colors
    Essity Acquires Distribution Rights to Sorbact in Australia and New Zealand
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    New Biosealant Could Stabilize Cartilage, Boost Healing After Injury
    Google Executive Joins SeaSpine's Board of Directors
    HSS and LimaCorporate Open Provider-Based 3D Design and Printing Facility
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Tive Multi-sensor Tracker Solo 5G Relies on Sensirion SHT33
    VTT in 2020: Successful Year Despite Globally Challenging Times
    Lux Research: 3D Printing Market to Reach $51 Billion in 2030

    Copyright © 2021 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