• 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
    MICRO Expands with New Facility in Costa Rica

    DiaSorin to Buy Luminex for $1.8B

    Endologix Acquires PQ Bypass

    Algorithm Can Predict Acute Kidney Injury Sooner Than Hospital Systems

    Elixir Medical Begins Study of Metallic Implant for CAD Treatment
    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.

    Unicep

    Concise Engineering

    Qosina Corp.

    Medicoil
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    EMS Providers Valued for Product Customization, Medical Certification Expertise

    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
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    PTI Engineered Plastics Inc.

    Concise Engineering

    FUTEK Advanced Sensor Technology Inc.

    Spectrum Plastics Group
    • 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 ClearMind Biomedical's Axonpen Neuroendoscope

    Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.

    FDA OKs ClearMind Biomedical
    First in man clinical trial in operation.
    PR Newswire01.12.21
    ClearMind Biomedical has received FDA clearance for its novel neuroendoscope, the Axonpen System, for illumination and visualization of intracranial tissue and fluids, and the controlled aspiration of tissue and/or fluid during surgery.
     
    Requiring only a narrow channel of 6.5mm through the skull for insertion into the brain, the steerable Axonpen combines excellent tissue visualization, suction, and irrigation functions. It has a working channel for use with accessory surgical devices. The Axonpen System is the first neuroendoscope to integrate all these capabilities into one, simple to use, minimally invasive operating platform. 
     
    The Axonpen System supports a clinical shift in the minimally invasive removal of unwanted intracranial fluid and tissue, as commonly manifested in cases of intracerebral hemorrhage (ICH) and subdural hematomas. 
     
    "One Doctor, One Hour" was the objective driving the ClearMind founders to create the Axonpen System. Meeting this objective allows a single surgeon to complete some critical surgeries in one hour, even at small-scale regional hospitals. More importantly, access to faster neurosurgical interventions after suffering a hemorrhagic stroke or other fluid producing injury has the potential to improve patient outcomes, including survival. 
     
    "Up until the introduction of the Axonpen System, there has been no other integrated neuroevacuation device on the market for minimally invasive neurosurgery," explained Carrey Yang, ClearMind's CEO. "Often, expensive and complex equipment is necessary to perform the surgery, requiring that patients be transferred to a large medical center, delaying the moment surgery can begin."
     
    Yang also pointed out examples where the Axonpen may provide benefit: "The most critical period in treating ICH is the first 24 hours, underscoring the importance of swift and effective emergency treatment." He went on to comment that apart from the speediness of treatment, the Axonpen's low rebleeding risk is an equally important advantage.
     
    The first post-market human trial of the Axonpen has commenced. The trial, which will consist of 30 subjects, is focused on procedural safety and generating the correlation between the use of the Axonpen System and functional independence measures. U.S. human trials are planned for the 3rd quarter of 2021.
    Related Searches
    • Neurological
    • Surgical
    Related Knowledge Center
    • Surgical
    • Neurological

    Related Breaking News

    • Neurological
      ZOLL Buys Sleep Apnea Device Maker Respicardia

      ZOLL Buys Sleep Apnea Device Maker Respicardia

      Respicardia's remedē system, an implantable neurostimulator, treats central sleep apnea.
      Sam Brusco, Associate Editor 04.12.21

    • Cardiovascular | Surgical
      Abbott

      Abbott's Next-Gen TriClip Earns EU Nod

      New enhancements to first-of-its-kind device uniquely developed for the difficult-to-treat tricuspid valve.
      Sam Brusco, Associate Editor 04.08.21

    • Surgical
      Bausch + Lomb

      Bausch + Lomb's ClearVisc Dispersive Ophthalmic Viscosurgical Device Approved

      Offers corneal protection and visibility during ophthalmic surgery.
      Sam Brusco, Associate Editor 04.07.21


    • Surgical
      Royal Philips’ SmartCT Application Software Receives FDA 510(k) Clearance

      Royal Philips’ SmartCT Application Software Receives FDA 510(k) Clearance

      Helps enhance clinical confidence, smooths workflows, and increases productivity.
      Charles Sternberg, Assistant Editor 04.06.21

    • Surgical
      Ethicon Launches Echelon+ Stapler

      Ethicon Launches Echelon+ Stapler

      Increases staple line security and reduces complications in surgery.
      Charles Sternberg, Assistant Editor 04.01.21

    • Neurological
      Encora

      Encora's Tremor Reducing Wristband Gains Breakthrough Status

      Indicated to provide temporary hand tremor relief in adult essential tremor or Parkinson's patients.
      Sam Brusco, Associate Editor 03.31.21


    • Surgical
      Boston Scientific to Pay $189M to Settle Charges Over Surgical Mesh

      Boston Scientific to Pay $189M to Settle Charges Over Surgical Mesh

      The company misled consumers about its surgical mesh devices' safety and effectiveness.
      Sam Brusco, Associate Editor 03.25.21

    • Surgical
      Olympus Files Patent Suit Against Cantel/Medivators

      Olympus Files Patent Suit Against Cantel/Medivators

      Alleges AmplifEye Endoscopic Device infringes on two Olympus patents for its ENDOCUFF single-use devices.
      Sam Brusco, Associate Editor 03.23.21

    • Cardiovascular | Surgical
      CSI Buys Peripheral Support Catheters from WavePoint Medical

      CSI Buys Peripheral Support Catheters from WavePoint Medical

      Agreement also includes development of portfolio of chronic total occlusion products.
      Sam Brusco, Associate Editor 03.22.21


    • 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

    • Surgical
      FDA OKs Asensus

      FDA OKs Asensus' Senhance for General Surgery

      Indication expansion allows Senhance's use in high-value, complex reconstructive surgeries.
      Sam Brusco, Associate Editor 03.03.21

    • Surgical
      Boston Scientific to Buy Lumenis

      Boston Scientific to Buy Lumenis' Surgical Biz for $1B

      Gains laser systems, fibers, and accessories for urology and otolaryngology procedures.
      Sam Brusco, Associate Editor 03.03.21


    • Surgical
      Memic Receives FDA Marketing Authorization for Hominis

      Memic Receives FDA Marketing Authorization for Hominis

      Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.
      Charles Sternberg, Assistant Editor 03.02.21

    • Surgical
      Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz

      Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz

      Medi-Tate's iTind nitinol implant supports lower urinary tract symptom relief due to benign prostatic hyperplasia.
      Sam Brusco, Associate Editor 03.02.21

    • Surgical
      TransEnterix Changes Name to Asensus Surgical

      TransEnterix Changes Name to Asensus Surgical

      The rebranded firm also introduced a new surgical category—performance-guided surgery.
      Sam Brusco, Associate Editor 02.24.21


    Trending
    • Endologix Acquires PQ Bypass
    • Survey: Remote Patient Monitoring To Match Or Surpass In-Patient Within Five Years
    • DiaSorin To Buy Luminex For $1.8B
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Avantor To Acquire Ritter GmbH And Affiliates For $1B
    Breaking News
    • MICRO Expands with New Facility in Costa Rica
    • DiaSorin to Buy Luminex for $1.8B
    • Endologix Acquires PQ Bypass
    • Algorithm Can Predict Acute Kidney Injury Sooner Than Hospital Systems
    • Elixir Medical Begins Study of Metallic Implant for CAD Treatment
    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

    4-week Fish Oil Regimen Showed Significant Muscular Damage Protection in Recent Study
    Review Covers Role of Vitamin K2 in the ‘Calcium Paradox’
    KD Pharma Acquires Rohner AG Manufacturing Assets
    Coatings World

    Latest Breaking News From Coatings World

    Jebsen & Jessen, Innospec Sign Distribution Agreement
    Sika Expands Production Capacity in Qatar
    Sto Corp. ISO Certifications Extended
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MICRO Expands with New Facility in Costa Rica
    DiaSorin to Buy Luminex for $1.8B
    Endologix Acquires PQ Bypass
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Catalent Biologics Completes Madison Expansion
    Lonza Expands PyroTec PRO for Endotoxin Testing
    FDA Accepts Airway Therapeutics’ IND for COVID Treatment
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Revieve Launches Skin Coach
    Carlyle Group Acquires Majority Stake in Beautycounter
    The Honest Co. Files for an Initial Public Offering
    Happi

    Latest Breaking News From Happi

    Babor Professional Skin Care Names McCaffrey as Vice President of Sales
    Diamond Chemical Appoints Technical Service Representative
    Carlyle To Acquire Majority Stake in Beautycounter
    Ink World

    Latest Breaking News From Ink World

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

    Latest Breaking News From Label & Narrow Web

    Enprom helps converter respond to flexible packaging needs
    anytron assists medical device company with labeling
    Dantex debuts new capabilities with white ink opacity
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Aries Face Masks Meet ASTM Standards
    Tufropes Launches Inherently Antibacterial and Antimicrobial Spunbond
    NXTNano Adding Three Lines
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    GreenBone Ortho Closes 10 Million Euros Series B Funding Round
    SynerFuse, Cirtec Medical Partner to Develop Back Pain Management Device
    New Biosealant Could Stabilize Cartilage, Boost Healing After Injury
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Virtual ASMC 2021 Spotlights Advanced Semiconductor Manufacturing Excellence
    First Solar Series 6 CuRe has Industry’s Lowest Warranted Degradation Rate
    SEMI: 2020 Global Semiconductor Equipment Sales Surge 19% to Industry Record $71.2 Billion

    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