• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Manufacturing
    • Markets
    • Top 10 Orthopedic Device Firms
    • Buyers' Guide
    • Events
    • More
  • Magazine
  • News
  • Exclusives
  • Manufacturing
  • Markets
  • Top 10 Orthopedic Device Firms
  • Buyers' Guide
  • Events
  • Current & Past Issues
    Features
    Departments
    Columns
    Editorial
    Digital Edition
    Subscribe Now
    Advertise Now
    Editorial Guidelines
    eNewsletter Archive
    Top Features
    The 11 Steps of Metrology Matching

    Realizing the Promise of Pre-Validated Packaging

    Creating a Natural Extension: Instrument Manufacturing

    Squeaky Clean: Orthopedic Device Packaging & Sterilization

    Natural Selection: Biologics in Orthopedics
    Breaking News
    Certifications
    Clinical Trials
    Device Approvals & Patents
    Financial & Deals
    International
    Market Data & Trends
    OEM News
    People
    Product & Service Releases
    Products
    Quality, Recalls & Risk
    Regulatory & Legal
    Supplier & Contract Mfg.
    Live From Shows
    Top News & Features
    Nevro Files U.S. Patent Lawsuit Against Stimwave

    Global Study Finds High Success Rate for Hip and Knee Replacements

    Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study

    McGinley Orthopedics Recruits Industry Leader as New CEO

    Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion
    3-D Printing/Additive Mfg.
    Assembly & Automation
    Biocompatibility & Testing
    Clean Room
    Coatings/Surface Modification
    Contract Manufacturing
    Design
    Extrusion
    Finishing
    Forging & Casting
    Instruments, Cases & Trays
    International/Offshoring
    Laser Processing
    Materials
    Machining & Tooling
    Molding
    Packaging & Sterilization
    Prototyping
    Research & Developement
    Software & Quality
    Staffing, Training & Prof. Dev.
    Supply Chain

    Nevro Files U.S. Patent Lawsuit Against Stimwave

    Global Study Finds High Success Rate for Hip and Knee Replacements

    McGinley Orthopedics Recruits Industry Leader as New CEO

    Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion

    Strengthening Muscular Rehabilitation with Objective Clinical Data
    Biologics
    Bracing/Prosthetics
    Extremities
    Imaging
    Instruments
    Large Joint
    MIS/Robotics
    Spine/Neurology
    Trauma/Sports
    Top Markets
    Strengthening Muscular Rehabilitation with Objective Clinical Data

    Nail Simplifies Two-Procedure Rotator Cuff Repair

    Treating that Pain-in-the-Neck Smartphone

    Sounding Board: 2018 Reflections and Looking Ahead

    Creating Customized Orthopedic Products Using Handheld 3D Scanners
    Companies
    Categories
    Company Capabilities
    White Papers
    Add New Company
    International Buyers Guide Companies
    Tegra Medical

    Paragon Medical

    Nelson Laboratories LLC

    Atlas Vac Machine

    STAT Design LLC
    Industry Events
    Webinars
    • Magazine
      • Current & Past Issues
      • Features
      • Editorial
      • Departments
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • Companies
      • Categories
      • Company Capabilities
      • White Papers
      • Add Your Company
    • Manufacturing
      • 3-D Printing/Additive Mfg.
      • Assembly & Automation
      • Biocompatibility & Testing
      • Clean Room
      • Coatings/Surface Modification
      • Contract Manufacturing
      • Design
      • Extrusion
      • Finishing
      • Forging & Casting
      • Instruments, Cases & Trays
      • International/Offshoring
      • Laser Processing
      • Materials
      • Machining & Tooling
      • Molding
      • Packaging & Sterilization
      • Prototyping
      • Research & Developement
      • Software & Quality
      • Staffing, Training & Prof. Dev.
      • Supply Chain
    • Markets
      • Biologics
      • Bracing/Prosthetics
      • Extremities
      • Imaging
      • Instruments
      • Large Joint
      • MIS/Robotics
      • Spine/Neurology
      • Trauma/Sports
    • Top 10 Orthopedic Device Firms
    • Online Exclusives
    • Slideshows
    • Videos
    • Webinars
    • Events
      • Industry Events
    • Live from Show Event
    • About Us
      • About Us
      • Contact Us
      • Privacy Policy
      • Terms of Use
      • Advertise With Us
    Breaking News

    TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments

    Clearance will allow the Senhance System to be used for microlaparoscopic surgeries.

    Related CONTENT
    • FDA Clears Ceterix Orthopaedics' NovoStitch Pro Meniscal Repair System
    • Shouldering Growth: An Examination of the Extremities Implant Sector
    • Modifications to a Cleared Device: Letter to File or New 510(k)?
    • FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
    • CoreLink Acquires Israeli Firm Expanding Orthopedics Inc.
    Business Wire10.12.18
    TransEnterix Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, has received U.S. Food and Drug Administration 510(k) clearance for 3 millimeter diameter instruments, as well as additional 5 millimeter Senhance System instruments.
     
    The clearance of the 3 millimeter diameter instruments will allow the Senhance to be used for microlaparoscopic surgeries, enabling surgeons to operate through tiny incisions considered virtually scarless for patients.
     
    “The ability to perform microlaparoscopic procedures using 3 millimeter instruments represents an unparalleled shift in the world of robotic surgery and a capability exclusive to the Senhance system,” said Todd M. Pope, TransEnterix CEO. “The addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities within digital laparoscopy.”
     
    “Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” said Dr. Steven D. McCarus, M.D., FACOG, chief of Gynecologic Surgery at Florida Hospital Celebration Health. “Patients find such small incisions to be virtually scarless and cosmetically desirable. Surgeons may find that using such tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions.”
     
    TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The company is focused on the commercialization of the Senhance Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the United States, the European Union and select other countries. 
    Related Searches
    • surgery
    • medical
    • FDA
    • minimally invasive
    Suggested For You
    NuVasive Partners with Biedermann Technologies on Complex Spine Solutions NuVasive Partners with Biedermann Technologies on Complex Spine Solutions
    Alphatec Adds Key Executive to Management and Expands Market Development Team Alphatec Adds Key Executive to Management and Expands Market Development Team
    Testing in a Rapidly Changing World Testing in a Rapidly Changing World
    Giving Back: An Examination of the Spine Technologies Sector Giving Back: An Examination of the Spine Technologies Sector
    NuVasive Launches TLX 20 Degree Expandable Spinal Interbody Implant NuVasive Launches TLX 20 Degree Expandable Spinal Interbody Implant
    FDA Clears Ceterix Orthopaedics FDA Clears Ceterix Orthopaedics' New Suture Cartridge for Mensical Repair
    2. DePuy Synthes 2. DePuy Synthes
    Innovation in the 510(k) Space: A Case for Incrementalism Innovation in the 510(k) Space: A Case for Incrementalism
    FDA’s Educational Opportunities Abound FDA’s Educational Opportunities Abound
    Self-Fitting Scaffold Promotes Bone Regeneration Self-Fitting Scaffold Promotes Bone Regeneration
    Lipogems Receives FDA Clearance For Microfragmented Adipose Tissue System Lipogems Receives FDA Clearance For Microfragmented Adipose Tissue System
    Arthrosurface receives FDA Clearance of Patellofemoral WaveKahuna Arthroplasty System Arthrosurface receives FDA Clearance of Patellofemoral WaveKahuna Arthroplasty System
    SeaSpine Names Senior Vice President of Spinal Systems SeaSpine Names Senior Vice President of Spinal Systems
    Zavation Medical Adds New Member to its Board Zavation Medical Adds New Member to its Board
    CoreLink Acquires Israeli Firm Expanding Orthopedics Inc. CoreLink Acquires Israeli Firm Expanding Orthopedics Inc.

    Related Breaking News

    • Spine/Neurology
      Nevro Files U.S. Patent Lawsuit Against Stimwave

      Nevro Files U.S. Patent Lawsuit Against Stimwave

      Nevro asserts Stimwave is infringing patent's covering the Senza system and HF10 therapy.
      PR Newswire 02.15.19

    • Large Joint
      Global Study Finds High Success Rate for Hip and Knee Replacements

      Global Study Finds High Success Rate for Hip and Knee Replacements

      Findings showed eight out of ten total knee replacements and six out of ten total hip replacements will still be in place after 25 years.
      University of Bristol 02.15.19

    • Spine/Neurology
      Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study

      Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study

      SIMPACT is a cannulated and fenestrated screw, intended for sacroiliac joint fusion.
      Business Wire 02.15.19


    • MIS/Robotics
      McGinley Orthopedics Recruits Industry Leader as New CEO

      McGinley Orthopedics Recruits Industry Leader as New CEO

      Carl O'Connell most recently served as CEO of Xtant Medical.
      PR Newswire 02.14.19

    • Spine/Neurology
      Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion

      Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion

      Trial conducted by Inspired Spine.
      PR Newswire 02.14.19

    • Tegra Medical Names New GM

      Tegra Medical Names New GM

      Hal Blenkhorn promoted to general manager of Franklin location.
      Tegra Medical 02.13.19


    • Integra Launches the Panta 2 TTC Arthrodesis Nail System

      Integra Launches the Panta 2 TTC Arthrodesis Nail System

      The product is designed to achieve bone healing through appropriate bone fixation and bone compression.
      Globe Newswire 02.13.19

    • 3-D Printing/Additive Mfg. | Spine/Neurology
      PrinterPrezz & SI Bone Team Up to Advance 3D Printed Orthopedic Tech

      PrinterPrezz & SI Bone Team Up to Advance 3D Printed Orthopedic Tech

      PrinterPrezz will provide SI-BONE with development and build services for potential future 3D-printed advanced medical devices and implants.
      Business Wire 02.12.19

    • Zimmer Biomet Appoints Senior Vice President, Chief Human Resources Officer

      Zimmer Biomet Appoints Senior Vice President, Chief Human Resources Officer

      Company recruited new executive from Pfizer.
      Zimmer Biomet Holdings Inc. 02.12.19


    • Spine/Neurology
      Alphatec Provides Update on NuVasive Patent Lawsuit

      Alphatec Provides Update on NuVasive Patent Lawsuit

      Several favorable developments were announced regarding the company's ongoing patent litigation.
      GlobeNewswire 02.11.19

    • Bracing/Prosthetics
      Motorized Brace to Help Children with Cerebral Palsy

      Motorized Brace to Help Children with Cerebral Palsy

      Research team receives start-up funding to develop first-of-its-kind "artificial muscle."
      University of Delaware 02.11.19

    • Spine/Neurology
      FDA Approves Orthofix

      FDA Approves Orthofix's M6-C Artificial Cervical Disc for Cervical Disc Degeneration Treatment

      The disc was developed by Spinal Kinetics, a company Orthofix acquired last spring.
      Business Wire 02.11.19

    • American Academy of Orthopaedic Surgeons Announces its Musculoskeletal Tumor Registry Pilot

      American Academy of Orthopaedic Surgeons Announces its Musculoskeletal Tumor Registry Pilot

      Year-long effort includes six pilot sites at major U.S. academic center.
      American Academy of Orthopaedic Surgeons 02.08.19

    •  Trice Medical Acquires SegWAY Orthopaedics

      Trice Medical Acquires SegWAY Orthopaedics

      Acquisition creates first company to offer product line for minimally invasive orthopedic diagnostics and surgical solutions.
      Business Wire 02.07.19

    • Gramercy Extremity Orthopedics Receives Patent for Variable Angle Locking Technology

      Gramercy Extremity Orthopedics Receives Patent for Variable Angle Locking Technology

      The patent covers a design that allows a screw to be fixed at various angles and orientations using self-aligning washers within the plate hole.
      EINPresswire.com 02.07.19


    Breaking News
    • Nevro Files U.S. Patent Lawsuit Against Stimwave
    • Global Study Finds High Success Rate for Hip and Knee Replacements
    • Life Spine Announces Initiation of SIMPACT Sacroiliac Joint Fixation Outcomes Study
    • McGinley Orthopedics Recruits Industry Leader as New CEO
    • Study Shows Safety, Efficacy of Radiological Outcomes for Oblique Lateral Lumbar Interbody Fusion
    View Breaking News >
    CURRENT ISSUE

    January/February 2019

    • The 11 Steps of Metrology Matching
    • Realizing the Promise of Pre-Validated Packaging
    • Creating a Natural Extension: Instrument Manufacturing
    • Squeaky Clean: Orthopedic Device Packaging & Sterilization
    • Natural Selection: Biologics in Orthopedics
    • 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”.

    • privacy policy
    • term and condition
    • about us
    • contact us

    follow us

    Subscribe

    magazines

    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image

    Copyright © 2019 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