• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Masimo wins FDA nod for pediatric O3 regional oximetry indication

Masimo wins FDA nod for pediatric O3 regional oximetry indication

May 30, 2017 By Fink Densford

Masimo

Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for a pediatric indication for O3 regional oximetry with its O3 pediatric sensor.

With the extended indication, the Irvine, Calif.-based said that O3 regional oximetry monitoring will be available for pediatric patients which weigh more than 11lbs and less than 88lbs.

The technology works by using near-infared spectroscopy to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region.

“O3 regional oximetry provides access to valuable data about cerebral oxygen saturation. With adult and pediatric trend accuracy of 3% and absolute accuracy of 4% and 5% on adults and pediatrics respectively, without controlling CO2, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatrics as young as three-months old,” CEO & founder Joe Kiani said in a prepared statement.

Earlier this month, Masimo said it launched the Early Warning Score system for the Root patient monitoring and connectivity hub.

The EWS system is designed to aggregate information from multiple vital signs and clinical observations to determine the potential degree of patient deterioration, the company said.

Filed Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Masimo

More recent news

  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Endogenex data supports type 2 diabetes procedure
  • Ambu wins FDA clearance for first single-use cysto-nephroscope
  • Tandem Diabetes Care pairs t:slim X2 pump with Abbott FreeStyle Libre 3 Plus in U.S.
  • Ypsomed, CamDiab to integrate Abbott dual glucose-ketone sensor into automated insulin delivery system

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy