• 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
    Spartech Promotes Three Staff Members

    Elisabeth Lackner Named Chief Scientific Officer at Element Materials Technology

    Natech Plastics Purchases Three New Injection Molding Machines

    Boston Scientific Nabs Obsidio, Boosts Embolization Portfolio

    Diabetes Care Devices Market to Top $87B by 2030
    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
    JBC Technologies

    BMP Medical

    Trademark Plastics 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
    JBC Technologies

    BMP Medical

    Trademark Plastics 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

    SoftWave Cleared by FDA for Burn Wound Treatment

    Achieves clearances for both acute and chronic wounds.

    SoftWave Cleared by FDA for Burn Wound Treatment
    SoftWave’s technology uses an unfocused extracorporeal shock wave to promote both a physical and biological response in order to improve wound healing. Image courtesy of SoftWave Tissue Regeneration Technologies.
    Related CONTENT
    • Breakthrough Device Designation Granted for New Neuromodulation Platform
    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    • First CellFX Procedure Performed in Canada
    • RedDress’ ActiGraft System Receives New FDA Clearance
    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    SoftWave Tissue Regeneration Technologies09.02.20
    On August 28, SoftWave Tissue Regeneration Technologies, a disruptive bio-medical device company, was cleared by the FDA for the treatment of superficial, partial-thickness, second-degree burns in adults. SoftWave also has clearance for the treatment of Diabetic Foot Ulcers (DFU’s), making it the only ESWT company to have two clearances for both acute (burns) and chronic wounds (DFU’s). SoftWave therapy gives physicians, who treat burn patients, another option in healing burn wounds.
     
    Each year in the United States, approximately 450,000 patients receive medical attention at emergency rooms for burn related injuries. Most superficial wounds heal in two weeks; however, patients who suffer severe burns must endure intense physical and psychological pain during the burn injury treatment phase. There are over 3,400 burn injury deaths, including 1,100 children every year. The CDC estimates that $7.5 billion dollars are spent each year for burn related injuries. After the treatment phase is over and wounds are healed, scarring and disfigurement may interfere with movement, mobility, and daily life functions, resulting in a lifetime of physical and emotional burdens.
     
    How It Works
    SoftWave’s technology uses an unfocused extracorporeal shock wave (uESWT) to promote both a physical and biological response in order to improve wound healing. In a prospective randomized trial conducted by Dr. Christian Ottomann, published in the Annals of Surgery, significant accelerated epithelialization was demonstrated in the patients who had undergone uESWT (9.6 ± 1.7 days) as compared to the patients who did not undergo uESWT (12.5 ± 2.2 days); a statistically significant reduction in the days required for healing (±3). This change is a substantial factor for any burn patient.

    The SoftWave biological response for wound healing is associated with neovascularization, and an increase in oxygenation and perfusion, ultimately resulting in angiogenesis. The hypothesized mechanisms of action for accelerated wound healing include stem cell activation and recruitment, and a reduction in the inflammation as proven in the company's published TLR3 model.
    Suggested For You
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    Precision Coating Merges with N2 Biomedical Precision Coating Merges with N2 Biomedical
    FDA Clears Inova Diagnostics FDA Clears Inova Diagnostics' Digital Multi-Analyte System
    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
    Improved Outcomes Proven With Insulet’s Omnipod 5 System Improved Outcomes Proven With Insulet’s Omnipod 5 System
    Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA
    Molli Surgical Molli Surgical's Breast Tumor Marker
    The Benefits of Computer Vision Technology for Healthcare Applications The Benefits of Computer Vision Technology for Healthcare Applications
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation

    Related Breaking News

    • Breakthrough Device Designation Granted for New Neuromodulation Platform

      Breakthrough Device Designation Granted for New Neuromodulation Platform

      In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
      Business Wire 09.22.21

    • Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

      Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.
      Business Wire 09.22.21

    • First CellFX Procedure Performed in Canada

      First CellFX Procedure Performed in Canada

      Pulse Biosciences expands its controlled launch of the CellFX System into the country.
      Business Wire 09.22.21


    • RedDress’ ActiGraft System Receives New FDA Clearance

      RedDress’ ActiGraft System Receives New FDA Clearance

      ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.
      Globe Newswire 09.22.21

    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      The two deals will strengthen Heraeus' healthcare and medtech portfolio.
      Heraeus 09.22.21

    Loading, Please Wait..

    Trending
    • Diabetes Care Devices Market To Top $87B By 2030
    • Boston Scientific Nabs Obsidio, Boosts Embolization Portfolio
    • RSNA 2021: Canon Medical Unveils Vantage Fortian 1.5T MRI
    • Abbott Invests €440 In New Irish Facility
    • Microneedle Patch Glucose Monitor Proves Virtually Painless And More Accurate
    Breaking News
    • Spartech Promotes Three Staff Members
    • Elisabeth Lackner Named Chief Scientific Officer at Element Materials Technology
    • Natech Plastics Purchases Three New Injection Molding Machines
    • Boston Scientific Nabs Obsidio, Boosts Embolization Portfolio
    • Diabetes Care Devices Market to Top $87B by 2030
    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

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures Posts Record 2Q 2022 Results
    Advanced Polymer Coatings Strikes Series of New Tanker Deals
    Barentz Named Distributor for Pilot Chemical Segments in US and Canada
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Spartech Promotes Three Staff Members
    Elisabeth Lackner Named Chief Scientific Officer at Element Materials Technology
    Natech Plastics Purchases Three New Injection Molding Machines
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Novavax Submits EUA for Protein-based COVID-19 Vax Booster
    BeiGene, Ontada Enter Strategic Oncology Alliance
    AskBio Appoints Clinical Ops Executives
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Mary Kay Supports International Women's Forum's Latest Research
    Vegamour Launches in the UK
    Maelys Rolls Out to Ulta Beauty
    Happi

    Latest Breaking News From Happi

    Dr. Bronner’s Releases 2022 All-One! Report, ‘Leading with Heart’
    In-Cosmetics Asia Returns to Bangkok to Deliver Look at Market Trends and Ingredient Innovations
    Perfect Corp. AI Skin Analysis Beauty SaaS Brand Console Is HIPAA-Compliant
    Ink World

    Latest Breaking News From Ink World

    BASF Breaks Ground on Riverfront Park in East Newark
    Roland DG Corporation to Relocate HQ to Miyakoda, Japan
    Gallus Launches Gallus One, Its First Fully Digital Inkjet Label Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Color-Logic partners to feature metallics at autumn events
    New Era Converting Machinery heads to The Battery Show
    Cyngient, Imageworx partner at Labelexpo for security labeling innovation
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Babyganics Introduces Triple Dry Diapers
    Daio Paper Acquires Pet Care Products Manufacturer
    Honest Reports Increased Revenue
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FundamentalVR Raises $20 Million in Series B Funding
    Bioventus Achieves Strong Growth in Q2 2022
    Bone Void Fillers Market Growing at 6%
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    onsemi Celebrates Expansion of Silicon Carbide Production Facility in New Hampshire
    Applied Materials CTO Dr. Om Nalamasu Receives IEEE Frederik Philips Award
    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories

    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