• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    maxon

    FUTEK Advanced Sensor Technology Inc.

    K-Tube Technologies

    MW Life Sciences

    Element
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medicoil

    Qosina Corp.

    FUTEK Advanced Sensor Technology Inc.

    PTI Engineered Plastics Inc.

    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

    Cook Medical’s Cellvizio Receives Further 510(k) Clearance

    Cellvizio can now be used for in vivo imaging of the internal microstructure of tissues.

    Cook Medical’s Cellvizio Receives Further 510(k) Clearance
    Cellvizio is a probe-based CLE system, a visualization platform that incorporates laser scanning technology to generate images of the internal microstructure of tissues.
    Related CONTENT
    • The Heart of the Matter: Trends in Cardiology
    • FDA Expands Heart Valve Approval to Include Size for Newborn Patients
    • Cook Group Promotes Executive to Federal and International Government Affairs VP
    • AngioDynamics Receives FDA Expedited Access Pathway Designation for the NanoKnife System
    • Mauna Kea Technology Appoints 30-Year Healthcare Executive to its Board
    Business Wire03.20.18
    Cook Medical’s Cellvizio Confocal Laser Endomicroscopy (CLE) System and the Confocal Miniprobes have received additional 510(k) clearance from the U.S. Food and Drug Administration (FDA). Additional data provided in multiple peer-reviewed medical journals paved the way for this new clearance and indication for the Cellvizio system. This new indication states that it can be used for in vivo imaging of the internal microstructure of tissues, including the identification of cells and vessels and their organization or architecture during endoscopic procedures.
     
    “We are excited for this new clearance for Cellvizio and what it means for the patients we serve,” said DJ Sirota, vice president of Cook Medical. “The ability to identify cells and vessels and their organization or architecture should have a significant impact on the use of this system with urologists, and we are excited to work with Mauna Kea to bring this technology to the urology specialty.”
     
    Cellvizio is a probe-based CLE system, a visualization platform that incorporates laser scanning technology to generate images of the internal microstructure of tissues. The Confocal Miniprobes are made up of optical fiber bundles and other optical elements. They transmit the laser light to the tissue site and detect the fluorescence signal that is emitted back, which is turned into real-time images of the internal microstructure of tissues.
     
    Manufactured by Mauna Kea Technologies, the Cellvizio system and Confocal Miniprobes are available through distribution by Cook Medical.
    Related Searches
    • fluorescence
    • president
    • u.s. food and drug administration
    • data
    Related Knowledge Center
    • Patient Monitoring
    Suggested For You
    The Heart of the Matter: Trends in Cardiology The Heart of the Matter: Trends in Cardiology
    FDA Expands Heart Valve Approval to Include Size for Newborn Patients FDA Expands Heart Valve Approval to Include Size for Newborn Patients
    Cook Group Promotes Executive to Federal and International Government Affairs VP Cook Group Promotes Executive to Federal and International Government Affairs VP
    AngioDynamics Receives FDA Expedited Access Pathway Designation for the NanoKnife System AngioDynamics Receives FDA Expedited Access Pathway Designation for the NanoKnife System
    Mauna Kea Technology Appoints 30-Year Healthcare Executive to its Board Mauna Kea Technology Appoints 30-Year Healthcare Executive to its Board
    Medical Device Tax Suspended for Two Years...Again Medical Device Tax Suspended for Two Years...Again
    Mauna Kea Receives 14th FDA Clearance for the Cellvizio 100 Series Mauna Kea Receives 14th FDA Clearance for the Cellvizio 100 Series
    FDA Warns BD About Blood Collection Tubes Used in Lead Testing Kit FDA Warns BD About Blood Collection Tubes Used in Lead Testing Kit
    FDA Approves First Breakthrough-Designated Next-Gen Sequencing IVD Cancer Test FDA Approves First Breakthrough-Designated Next-Gen Sequencing IVD Cancer Test
    The Final Four: My Top Headlines for 2017 The Final Four: My Top Headlines for 2017
    Employee Feedback Should Be Part of a Product Safety Plan Employee Feedback Should Be Part of a Product Safety Plan
    Medtech Mettle: The 2017 Year in Review Medtech Mettle: The 2017 Year in Review
    Mauna Kea Technologies Appoints Deputy CEO and Chief Financial Officer Mauna Kea Technologies Appoints Deputy CEO and Chief Financial Officer
    Cellvizio Now CE Marked for Use During Robotic-Assisted Surgery Cellvizio Now CE Marked for Use During Robotic-Assisted Surgery
    FDA Commissioner Declares New Steps to Advance Medical Device Innovation FDA Commissioner Declares New Steps to Advance Medical Device Innovation

    Related Breaking News

    • 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

    • Patient Monitoring | Software & IT
      AI Metrics

      AI Metrics' Liver Imaging Software Earns FDA Nod

      Early-stage startup approved for low-cost, low-risk, non-invasive procedures for chronic liver disease patients.
      University of Alabama at Birmingham 12.09.20

    • Chronic Disease | Patient Monitoring
      FDA OKs Baxter

      FDA OKs Baxter's Homechoice Claria with Sharesource

      Sharesource is a two-way remote patient management platform for patients on peritoneal dialysis.
      Business Wire 11.23.20


    • Patient Monitoring
      CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System

      CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System

      PrecisionOne provides automated glucose regulation and real-time analysis of blood chemistry values for critical care patients.
      PR Newswire 11.23.20

    • Patient Monitoring
      Implantable Sensor Could Measure Bodily Functions, Then Safely Biodegrade

      Implantable Sensor Could Measure Bodily Functions, Then Safely Biodegrade

      Can monitor various forms of nitric oxide and nitrogen dioxide gas in the body.
      Penn State 11.12.20

    • Patient Monitoring
      Prevounce Health Launches Remote Patient Monitoring Module

      Prevounce Health Launches Remote Patient Monitoring Module

      The module combines digital spirometry, smart nebulizers, and pulse oximetry.
      PR Newswire 11.10.20


    • Neurological | Patient Monitoring
      FDA OKs Nightware

      FDA OKs Nightware's Device to Reduce Nightmare-Based Sleep Disturbance

      Device provides gentle vibration through touch based on analysis of heart rate and motion during sleep.
      U.S. Food and Drug Administration 11.09.20

    • Patient Monitoring
      Sony Updates NUCLeUS Imaging Platform

      Sony Updates NUCLeUS Imaging Platform

      Adds new functionality and features for use in hospitals.
      Sony 11.05.20

    • Cardiovascular | Electronics | Patient Monitoring
      Rubbery Bioelectronic Cardiac Patch Can Monitor, Treat Heart Disease

      Rubbery Bioelectronic Cardiac Patch Can Monitor, Treat Heart Disease

      The device can also harvest energy from the heart beating.
      University of Houston 11.04.20


    Trending
    • Meeting Critical Ventilator Product Requirements Amid Pandemic
    • STERIS To Buy Cantel Medical For $4.6B
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    What You're Reading on Happi.com
    Three Form Vertical Beauty Alliance
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    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