• 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
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    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
    Freudenberg Medical Adds Silicone Extrusion Capabilities in Massachusetts

    Positive Long-Term Prospects for Japanese Diabetes Care Market

    Digital X-Ray is as Effective as Lung Ventilation Perfusion in Detecting CTEPH

    CIBC Innovation Banking Provides $25M in Debt Financing to Podimetrics

    Invacare's Interim CEO Permanently Secures Job
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability

    Machining & Laser Processing Have Huge Parts to Play in Medtech Manufacturing

    Medtech R&D Teams Must Be Creative & Resilient to Survive

    Struggling Suppliers in Electronics Manufacturing Services (EMS)

    Deep (Brain) Thoughts with Medtronic's Neuromodulation President
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Deducing the Dual Reality of Elizabeth Holmes

    The Return of the AdvaMed MedTech Conference…Live!

    Material Matters: New Materials Call for New Thinking

    5 Ways to Maintain a Talent-Centric Mindset, Even During Economic Uncertainty

    The Changing Face of UK Medical Device Regulations: Most Recent Update
    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
    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Forefront Medical Technology

    Halkey-Roberts Corporation

    Medbio LLC
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Onshoring Medical Device Manufacturing Can Strengthen Supply Chains

    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    JBC Technologies

    Forefront Medical Technology

    Halkey-Roberts Corporation

    Medbio LLC
    • 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 Approves Medtronic's Connect Continuous Glucose Monitoring System

    'Smart' CGM system provides predictive alerts for dangerous sensor glucose levels; access to Sugar.IQ assistant with Watson.

    FDA Approves Medtronic
    The Guardian Connect CGM system works with 3 elements: a thin sensor, a small plastic transmitter attached to the sensor and the Guardian Connect app on a compatible iOS device. Image courtesy of Medtronic.
    Related Content
    • FDA Approves Abbott's Portico with FlexNav TAVR System
    • Medical Devices Market to Top $671.49 Billion by 2027
    • Indago Announces $10 Million Financing Close and Name Change
    • RapidPulse Closes $15 Million Series A Financing
    • Luis J. Malavé Joins Integrity Applications Board
    GlobeNewswire03.13.18
    Medtronic plc announced it received U.S. Food and Drug Administration (FDA) approval for its Guardian Connect continuous glucose monitoring (CGM) system, for people with diabetes ages 14 to 75 years. The Guardian Connect system is the first smart standalone CGM system1 to help people with diabetes stay ahead of high and low glucose events. The Guardian Connect system empowers people using multiple daily injections (MDI) to more proactively manage their diabetes.
     
    Featuring our latest predictive algorithms in diabetes care, the Guardian Connect system is the only standalone CGM system that can alert patients of potential high or low glucose events up to 60 minutes in advance. Using Guardian Sensor 3, the most advanced glucose sensor from Medtronic and the only sensor trusted to power a hybrid closed loop system, the Guardian Connect system was proven in a clinical study to accurately alert patients of 98.5 percent of hypoglycemic events2. Care partners can use the system to stay more informed about their loved ones with diabetes as well by tracking glucose in real-time or receiving text alerts.
     
    People using the Guardian Connect system will also have exclusive access to the groundbreaking Sugar.IQ smart diabetes assistant, empowering them to further address the daily challenges of diabetes. With artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how an individual's glucose levels respond to their food intake, insulin dosages, daily routines, and other factors3. Together with the Guardian Connect system, the Sugar.IQ assistant can turn difficult-to-determine patterns into personalized, actionable insights that help people with diabetes keep glucose levels in their target range.
     
    "Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors (CGM)" said Dr. Timothy Bailey, director of the AMCR Institute and clinical associate professor, University of California, San Diego. "Newer sensors paired with intelligent algorithms that help to both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensible for people who inject insulin. Greater utilization of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia."
     
    "The FDA approval of the Guardian Connect system fills a key gap that exists in diabetes treatment today—how to predict dangerous glucose highs and lows so they can be potentially avoided," said Annette Brüls, president, Diabetes Service and Solutions at Medtronic. "With predictive alerts and the Sugar.IQ assistant, the Guardian Connect system enables people to proactively manage their diabetes, so they can focus on living their life, not constantly worrying about their glucose levels."
     
    The Guardian Connect system will be available in the first quarter of Medtronic's fiscal year 2019 (May 2018—July 2018) for people with diabetes who are looking to take on a more proactive role in managing their diabetes.
     
    References
    1Smart CGM predicts future high and low sensor glucose events and provides access to additional algorithms and insights that can inform users of clinically relevant glucose patterns.
    2Guardian Connect system Instructions for Use (IFU). With a sensor glucose limit of 70 mg/dL, with calibration every 12 hours, both predictive and threshold alerts "On," within 30 minutes; abdomen sensor insertion. The correct detection rate for arm inserted sensor is 96.7 percent; with the same settings and conditions.
    3Based on information provided by the user. 
    Related Searches
    • glucose monitoring
    • university of california
    • power
    • monitoring
    Related Knowledge Center
    • Patient Monitoring
    Suggested For You
    FDA Approves Abbott FDA Approves Abbott's Portico with FlexNav TAVR System
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    Indago Announces $10 Million Financing Close and Name Change Indago Announces $10 Million Financing Close and Name Change
    RapidPulse Closes $15 Million Series A Financing RapidPulse Closes $15 Million Series A Financing
    Luis J. Malavé Joins Integrity Applications Board Luis J. Malavé Joins Integrity Applications Board
    FDA Approves TransMedics FDA Approves TransMedics' OCS Heart System for Donor Hearts
    Bright Future Ahead for Renal Denervation Bright Future Ahead for Renal Denervation
    Cala Health Expands its Executive Team Cala Health Expands its Executive Team
    LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform
    FDA OKs Abbott FDA OKs Abbott's FreeStyle Libre 2 iOS App
    Nevro Corp Receives FDA Approval for Senza System Nevro Corp Receives FDA Approval for Senza System
    Outset Medical Appoints Katie Szyman to its Board Outset Medical Appoints Katie Szyman to its Board
    Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027 Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027
    Substantial Growth Predicted for Global Ventilators Market Substantial Growth Predicted for Global Ventilators Market
    Fluid Management System Market to be Worth $23.2 Billion By 2028 Fluid Management System Market to be Worth $23.2 Billion By 2028

    Related Breaking News

    • Cardiovascular
      FDA Approves Abbott

      FDA Approves Abbott's Portico with FlexNav TAVR System

      Self-expanding TAVR valve features intra-annular (within the native valve) leaflets.
      PR Newswire 09.20.21

    • Medical Devices Market to Top $671.49 Billion by 2027

      Medical Devices Market to Top $671.49 Billion by 2027

      Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.
      Precedence Research 09.16.21

    • Indago Announces $10 Million Financing Close and Name Change

      Indago Announces $10 Million Financing Close and Name Change

      Lazurite Holdings is developing technology to create the operating room of the future.
      Business Wire 09.15.21


    • RapidPulse Closes $15 Million Series A Financing

      RapidPulse Closes $15 Million Series A Financing

      Two industry veterans join the team to support the development of a cyclic aspiration system for ischemic stroke.
      Globe Newswire 09.10.21

    • Luis J. Malavé Joins Integrity Applications Board

      Luis J. Malavé Joins Integrity Applications Board

      New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.
      Globe Newswire 09.08.21

    Loading, Please Wait..

    Trending
    • CGM Devices Could Become Main Glucose Monitoring Solution In U.S.
    • Study: Smartphone Therapeutic Helps Improve Fibromyalgia In Patients
    • MO SCI Acquires Assets Of 3M’s Advanced Materials Business
    • Positive Long-Term Prospects For Japanese Diabetes Care Market
    • The Future Of Biomedical Engineering Advancements
    Breaking News
    • Freudenberg Medical Adds Silicone Extrusion Capabilities in Massachusetts
    • Positive Long-Term Prospects for Japanese Diabetes Care Market
    • Digital X-Ray is as Effective as Lung Ventilation Perfusion in Detecting CTEPH
    • CIBC Innovation Banking Provides $25M in Debt Financing to Podimetrics
    • Invacare's Interim CEO Permanently Secures Job
    View Breaking News >
    CURRENT ISSUE

    January/February 2023

    • Struggling Suppliers in Electronics Manufacturing Services (EMS)
    • Machining & Laser Processing Have Huge Parts to Play
    • Medtech R&D Teams Must Be Creative & Resilient to Survive
    • Medtronic Neuromodulation President, Nnamdi Njoku, Interview
    • 6 Ways ERP Systems Help Medical Device Manufacturers Manage Risk and Profitability
    • 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

    NPA Announces Annual Capitol Hill Advocacy ‘Fly-In’ Day
    GOED Elects New Board Officers for 2023
    Aspire Hires Darrec Jones as VP of Business Development
    Coatings World

    Latest Breaking News From Coatings World

    Caren Hoffmann Appointed Vice President for BASF Mining Solutions
    Microban International Announces Four Senior Hires
    PPG Completes COLORFUL COMMUNITIES Project in Denmark
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Freudenberg Medical Adds Silicone Extrusion Capabilities in Massachusetts
    Positive Long-Term Prospects for Japanese Diabetes Care Market
    Digital X-Ray is as Effective as Lung Ventilation Perfusion in Detecting CTEPH
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Bristol Myers Squibb 4Q Results
    Actinium, NCI Partner to Develop Actimab-A in AML
    Astellas Announces New President and CEO and Management Structure
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Old Spice Introduces New Mascot and Launches ‘Smelf-Confidence’ Campaign
    KVD Beauty Launches Good Apple Serum Foundation
    Interpack 2023 to Focus on Sustainability
    Happi

    Latest Breaking News From Happi

    EvaClean Promotes Nicole Slacik to Executive Vice President, Healthcare
    Personal Care Brand Odele Expands into Ulta Beauty
    Clorox’s Eric Reynolds Elected Chair of American Cleaning Institute’s Board of Directors
    Ink World

    Latest Breaking News From Ink World

    Mexar Limited Awarded OEKO-TEX ECO PASSPORT Certification
    Graphic Packaging Named to Fortune's List of World's Most Admired Companies
    CDP Awards Amcor an A- for Ongoing Work on Climate Change Disclosure
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Fujifilm expands RxD inkjet pigment dispersions color range
    Anderson & Vreeland acquires flexo consumable assets from Grimco
    Hamillroad Software's Bellissima DMS honored in Brazil
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Avgol to Showcase Algaeing Colorants and Fibers at Filtech
    Uster to Host Webinar on Zero-Level Contamination Control
    Typar Expands Drainable Wrap Line
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Steady Growth Forecast for Global Orthobiologics Market
    ODT's Most-Read Stories This Week—Feb. 4
    Toetal Solutions Secures $1.8 Million in New Financing
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    onsemi Exceeds 4Q 2022 Expectations
    Emerson Launches Ovation Green Software Portfolio
    Graphene Flagship Researchers Examine Applications for Space

    Copyright © 2023 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