• 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
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    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
    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution

    Zeus Introduces Absorv XSE Oriented Tubing

    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access

    Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz

    Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Back to School for Medical Device Cybersecurity Training

    Driving Clinical Trial Excellence to Help Study Teams Run a Faster Relay Race

    Medtech’s Supply Chain: From Disruption to Opportunity

    Are Medtech’s Mega-Deals Gone For Good?

    Will a Skilling Gap Hinder Organizational Readiness for Medtech’s New Age of AI?
    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
    Halkey-Roberts Corporation

    Medbio LLC

    JBC Technologies

    Arthur G. Russell Co. Inc., The

    LEMO USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Wearables Are Changing the Way We Collect Real-World Data in Clinical Trials

    Could Medtech Ever Stop a Hospital Killer in Their Tracks?

    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    Medbio LLC

    JBC Technologies

    Arthur G. Russell Co. Inc., The

    LEMO USA Inc.
    • 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

    BellaSeno’s Design and Manufacturing Processes Fully ISO 13485 Certified

    Company transitions from research to manufacturing stage.

    BellaSeno’s Design and Manufacturing Processes Fully ISO 13485 Certified
    Senella is a biocompatible and fully absorbable breast scaffold made from a polymer that is FDA-approved and CE-marked for clinical applications. Image courtesy of BellaSeno.
    07.15.19
    BellaSeno GmbH, a company developing absorbable implants using additive manufacturing technology, announced it obtained full ISO 13485 certification for its design and additive manufacturing processes, ranging from the concept and prototype to the production of novel, non-silicone-based absorbable implants. In addition, the company raised a further €1 million from its existing investors, bringing the total amount raised by BellaSeno to €4.2 million. The proceeds will be used to fund a clinical trial of Senella, its first product, a biocompatible and fully absorbable breast scaffold made from a polymer that is FDA-approved and CE-marked for a wide variety of clinical applications. The trial is scheduled to start in Q4/2019.
     
    “We are now one of very few companies worldwide with an ISO 13485 certification covering the entire process of design and additive manufacturing of absorbable implants,” said Dr. Simon Champ, CEO of BellaSeno. “This is not only a prerequisite for the clinical trial of Senella, our first product, but also for closing contract manufacturing deals with companies seeking to develop and market their own absorbable implants for  a wide range of medical applications. We are offering the entire process under ISO 13485 certification to other medtech companies worldwide—from concept and inhouse design to manufacturing of prototypes, clinical trials, and series production.”
     
    He added that BellaSeno’s platform technology and patent-pending porous architectures can be used to design and manufacture a broad spectrum of soft and stiff devices for bone and soft tissue replacements.
     
    Absorbable implants guide the growth of natural tissue derived from the patient's own body and are slowly, but fully absorbed over a period of several days, months or years, dependent on the composition of the polymer employed. In contrast to many other implants, the result is a natural tissue with no foreign body remnants. BellaSeno’s implants are produced via additive manufacturing (AM), more commonly known as 3D-printing.
     
    Senella, is a patented, porous, absorbable scaffold which will provide a step change in the quality of life of breast reconstruction and augmentation patients around the world. The company believes it has the potential to disrupt the current breast surgery markets, which at present are dominated by silicone implants.
    Related Searches
    • patent
    • medical
    • clinical trial
    • ceo
    Related Knowledge Center
    • R&D & Design
    • Surgical
    • Contract Manufacturing
    Suggested For You
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    Innovation and Expertise Drive Evolution in Medical Device Manufacturing Innovation and Expertise Drive Evolution in Medical Device Manufacturing
    Freudenberg Buys Merit Medical Freudenberg Buys Merit Medical's Hypotube Manufacturing Biz
    4 Ways the IIoT Improves Medical Manufacturing 4 Ways the IIoT Improves Medical Manufacturing
    Managing Medtech Manufacturing Managing Medtech Manufacturing
    Trends for Medtech Contract R&D and Manufacturing Trends for Medtech Contract R&D and Manufacturing
    Oberg Medical Acquires Broad Peak Manufacturing Oberg Medical Acquires Broad Peak Manufacturing
    How To Conquer The Challenges Of Micro-Manufacturing How To Conquer The Challenges Of Micro-Manufacturing
    Micro Manufacturing – It Micro Manufacturing – It's a Small World, After All
    Engineering and Manufacturing Partnerships: The Key to Successful Combination Products Engineering and Manufacturing Partnerships: The Key to Successful Combination Products
    How Are MPO’s Top 30 Addressing COVID-19? How Are MPO’s Top 30 Addressing COVID-19?
    FDA Issues Warning Letters to Two Breast Implant Makers FDA Issues Warning Letters to Two Breast Implant Makers
    Molex Welcomes New SVP and President Molex Welcomes New SVP and President
    Sporting Goods Brand Now Making Millions Of Face Masks Sporting Goods Brand Now Making Millions Of Face Masks
    BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test

    Related Editorial

    • Contract Manufacturing
      The FDA Wants to Bring Manufacturing ‘Home’

      The FDA Wants to Bring Manufacturing ‘Home’

      The agency commissioners comment how the need to modernize the critical medical supply chain is long overdue.
      Sean Fenske, Editor-in-Chief 10.01.20

    • Contract Manufacturing
      Innovation and Expertise Drive Evolution in Medical Device Manufacturing

      Innovation and Expertise Drive Evolution in Medical Device Manufacturing

      MICRO’s president offers a look at the company his family founded 75 years ago as well as the industry it’s supported.
      Brian Semcer, President, MICRO 09.29.20

    • Contract Manufacturing | Tubing & Extrusion
      Freudenberg Buys Merit Medical

      Freudenberg Buys Merit Medical's Hypotube Manufacturing Biz

      Acquired assets will be absorbed by Cambus Medical located in Galway, Ireland.
      Business Wire 09.08.20


    • 3D/Additive Manufacturing | Software & IT
      4 Ways the IIoT Improves Medical Manufacturing

      4 Ways the IIoT Improves Medical Manufacturing

      The Industrial Internet of Things is expected to register annual growth of around 24 percent between now and 2023.
      Megan Ray Nichols, Science Writer; Editor, Schooled By Science 09.02.20

    • Managing Medtech Manufacturing

      Managing Medtech Manufacturing

      Succeeding Through Software
      09.02.20

    Loading, Please Wait..

    Trending
    • Cardiosense Begins SEISMIC-HF I Heart Failure Trial
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • Exo Introduces The Exo Iris To Market
    • A New Approach To Post-Market Surveillance
    • Varian Buys Aspekt Solutions To Bolster Advanced Oncology Biz
    Breaking News
    • 3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    • Zeus Introduces Absorv XSE Oriented Tubing
    • Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    • Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz
    • Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    View Breaking News >
    CURRENT ISSUE

    October 2023

    • MPO's 2023 Medtech Supply Chain Survey
    • Exceeding Medical Device Extrusion Expectations
    • Medical Device Micromolders Discuss the 'Minor Details'
    • 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

    PLT Health Solutions Granted Claims for Botanical Ingredient in Canada
    CRN Files Petition with FTC For Clarity on Health Products Compliance Guidance
    Vitafoods Europe Relocates to Barcelona Starting 2025
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Partners with DHL Express
    Micro Powders Showcases Natural, PTFE Alternative Additives at 2023 WCS
    U.S. Green Building Council and RMI Release Report to Drive Action on Embodied Carbon in Buildings
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    Zeus Introduces Absorv XSE Oriented Tubing
    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ono, Admid Partner on Novel Antibody Drugs in Oncology
    Theradaptive Awarded DOD Clinical Trial Award of up to $7.4M
    Ginkgo Bioworks, Pfizer Enter Multi-Target RNA Discovery Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    NYX Professional Makeup Partners with the New York Liberty
    BASF and StitchCrew Introduce Educational Bootcamp for Indigenous Beauty Brands
    Top 10 Most Popular Fashion Designer Makeup Brands—According to Landys Chemist
    Happi

    Latest Breaking News From Happi

    Micro Powders Appoints IMCD US New Regional Distributor for Personal Care Products
    American Cleaning Institute Praises Draft Proposal on Cleaning Product Ingredient Transparency
    NYX Professional Makeup Inks First Partnership with The New York Liberty
    Ink World

    Latest Breaking News From Ink World

    Micro Powders Showcases New Natural, PTFE Alternative Additives at 2023 WCS
    Roland DG Direct-To-Film Printer Ink, Powder Receive ECO PASSPORT Certification
    INX Will Show Inkjet, Sustainable Packaging Solutions at PRINTING United
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    INX brings inkjet and sustainable packaging to PRINTING United Expo
    Schreiner MediPharm introduces Freeze-Light-Protect syringe label
    Kodak launches PRINERGY 10.0
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    ExxonMobil Works with JL Goor to Help Drive Growth in Ireland and U.K. Healthcare Sector
    Lee C. Stewart Resigns from Glatfelter Board
    Ana Fraisse Joins The American Cleaning Institute
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    CTL Amedica Granted ECAT Approval from Defense Logistics Agency
    Intech Acquires Lenkbar LLC
    ONWARD Completes First-in-Human for ARC-IM to Restore Upper Extremity Function
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Jabil Announces Definitive Agreement to Divest Mobility Business for $2.2B
    PPG and Flō-Optics Enter Exclusive Supplier Agreement
    SEMI North America Advisory Board Adds New Members

    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