• 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
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    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
    'Graft-on-a-Chip' Built to Improve Vascular Graft Success

    Abbott Invests €440 in New Irish Facility

    FDA Approves Guardant Health's NGS-Based Companion Diagnostic

    Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment

    NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    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
    Concise Engineering

    BMP Medical

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things

    Leveraging Open Healthcare Data Standards to Improve Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Concise Engineering

    BMP Medical

    Fusion Biotec Inc.

    Xact Wire EDM Corp.

    Cirtec Medical
    • 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

    First U.S. Study Subject Implanted With Senseonics' Eversense XL Sensor

    The move is part of the clinical trial for pre-market application submission to the FDA.

    First U.S. Study Subject Implanted With Senseonics
    The Eversense Continuous Glucose Monitoring System. Image courtesy of Senseonics Holdings Inc.
    Related CONTENT
    • Senseonics Eversense CGM Sensor Receives Indication for MRI
    • Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review
    • Chief Financial Officer at Senseonics Holdings to Retire
    • AWAK's Wearable Dialysis System Wins Breakthrough Device Designation
    • FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program
    Business Wire02.14.19
    Senseonics Holdings Inc., a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced that the extended life Eversense XL sensor that lasts up to 180 days has been implanted in the first U.S. study participant as part of the clinical trial for pre-market application submission to the U.S. Food and Drug Administration (FDA).
     
    The PROMISE clinical study is intended to evaluate the safety and efficacy of the Eversense CGM system in people with diabetes over a 180-day period. Approximately 180 study participants at up to 15 locations across the United States are planned to enroll in the study. The Eversense XL sensor previously received the CE Mark and is currently marketed to patients across the European Union.
     
    Senseonics also announced that the company has completed its submission of PMA supplements to the FDA to secure an insulin dosing claim and to remove the contraindication related to the magnetic resonance imaging (MRI) exposure on the 90-day system which is currently available in the United States.
     
    “I am thrilled to be able to offer a long term implantable sensor to my patients through the PROMISE 180-day clinical study,” said Dr. Mark Christiansen, co-medical director of Diablo Clinical Research and the first physician to insert the extended life long-term sensor. “We are looking forward to providing patients six months of continuous sensing and the potential benefits of a long-term sensor.”
     
    “We are pleased to have enrolled the first participant in this important study which demonstrates our continued progress in transforming CGM technology. This is the first study in the US in which participants are implanted with a single sensor designed to produce accurate continuous glucose measurements for half of a year,” said Tim Goodnow, Senseonics president and CEO. “Our submission of the supplements to secure the dosing claim and to remove the MRI contraindication for the current 90-Day Eversense system are significant step forward in reducing the burden of diabetes management and providing patients peace of mind.”
     
    Senseonics Holdings Inc. is a medical technology company focused on the design, development, and commercialization of transformative glucose monitoring products designed to help people with diabetes confidently live their lives with ease. From its inception, Senseonics has been advancing the integration of novel, fluorescence sensor technology with smart wearable devices. The Eversense CGM System received PMA approval from the FDA for up to 90 days of continuous use and is available in the United States. The Eversense XL CGM System received CE mark for up to 180 days of continuous use and is available in Europe.
    Related Searches
    • company
    • development
    • senseonics
    • first
    Suggested For You
    Senseonics Eversense CGM Sensor Receives Indication for MRI Senseonics Eversense CGM Sensor Receives Indication for MRI
    Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review
    Chief Financial Officer at Senseonics Holdings to Retire Chief Financial Officer at Senseonics Holdings to Retire
    AWAK AWAK's Wearable Dialysis System Wins Breakthrough Device Designation
    FDA FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program
    Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance Device to Objectively Assess Pressure Ulcer Risk Wins De Novo Clearance
    Senseonics Receives FDA Approval to Expand Eversense CGM Certification to Nurse Practitioners, PAs Senseonics Receives FDA Approval to Expand Eversense CGM Certification to Nurse Practitioners, PAs
    Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time
    Holiday Wish List, Part 1—Mike on Medtech Holiday Wish List, Part 1—Mike on Medtech
    FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns
    New Efforts to Strengthen FDA’s Expanded Access Program New Efforts to Strengthen FDA’s Expanded Access Program
    FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats FDA and DHS Begin Partnership to Address Medical Device Cybersecurity Threats
    FDA Approves New DNA-Based Test to Determine Blood Compatibility FDA Approves New DNA-Based Test to Determine Blood Compatibility
    Senseonics & Glooko Announce Partnership on Integrated Diabetes Management Senseonics & Glooko Announce Partnership on Integrated Diabetes Management

    Related Breaking News

    • Patient Monitoring
      Senseonics Eversense CGM Sensor Receives Indication for MRI

      Senseonics Eversense CGM Sensor Receives Indication for MRI

      Now patients who need to have an MRI do not need to remove the Eversense Sensor.
      Business Wire 01.31.19

    • Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review

      Latest Steps to Strengthen FDA’s 510(k) Program for Premarket Review

      The 510(k) program must keep pace with the important innovations FDA is seeing in device development.
      Scott Gottlieb, M.D., Commissioner; Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health;, U.S. Food and Drug Administration 01.23.19

    • Chief Financial Officer at Senseonics Holdings to Retire

      Chief Financial Officer at Senseonics Holdings to Retire

      Executive will remain with the company until a replacement is found.
      Business Wire 01.21.19


    • AWAK

      AWAK's Wearable Dialysis System Wins Breakthrough Device Designation

      The device allows dialysis to be performed "on-the-go."
      PR Newswire 01.11.19

    • Digital Health | Software & IT
      FDA

      FDA's New Actions Concerning the Digital Health Pre-Cert Pilot Program

      The program aims to promote a more efficient framework for the review of safe and effective digital health innovation.
      Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 01.08.19

    Loading, Please Wait..

    Trending
    • Cardinal Health CEO Mike Kaufmann Steps Down
    • BD Recalls Intraosseous Products Over Multiple Issues
    • Abbott Invests €440 In New Irish Facility
    • Medidata Unveils New Tech To Improve Clinical Trial Oversight
    • Chronic, Infectious Disease Prevalence To Benefit Vital Signs Monitoring Market
    Breaking News
    • 'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    • Abbott Invests €440 in New Irish Facility
    • FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    • Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
    • NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • 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

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Paul N. Gardner Now Offers Bacharach Sling Psychrometer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    J&J To Stop Global Sales of Talc-Based Products by 2023
    Net Sales Increase 2% for Naples Soap Company in Second Quarter
    Net Revenue Down 12% for Grove Collaborative in Second Quarter
    Ink World

    Latest Breaking News From Ink World

    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Paul N. Gardner Offers Bacharach Sling Psychrometer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Freudenberg to Present Friction Inserts for Wind Energy
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Bone Growth Stimulators Market to Top $3B by 2030
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi
    Identiv Delivers Impressive 41% Year-over-Year Growth in RFID Business

    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