• Connect with us
    • Information
      • About Us
      • Contact Us
      • Careers
      • Partnerships
      • Advertise With Us
      • Authors
      • Browse Topics
      • Events
      • Disclaimer
      • Privacy Policy
    • Australia
      North America
      World
    Login
    Investing News NetworkYour trusted source for investing success
    • North America
      Australia
      World
    • My INN
    Videos
    Companies
    Press Releases
    Private Placements
    SUBSCRIBE
    • Reports & Guides
      • Market Outlook Reports
      • Investing Guides
    • Button
    Resource
    • Precious Metals
    • Battery Metals
    • Base Metals
    • Energy
    • Critical Metals
    Tech
    Life Science
    Medical Device Market
    Medical Device News
    Medical Device Stocks
    • Medical Device Market
    • Medical Device News
    • Medical Device Stocks
    medical device investing

    TSO3 Expands Duodenoscope Regulatory Filing Strategy

    Bryan Mc Govern
    Jun. 14, 2017 09:10AM PST
    Medical Device Investing

    TSO3 announced its targeting a 510(k) clearance for their STERIZONE VP4 Sterilizer from US regulators.

    TSO3 (TSX:TOS) announced its targeting a 510(k) clearance for their STERIZONE VP4 Sterilizer from US regulators.
    As quoted in the press release:

    Plans are to launch regulatory filings with US regulators for both the Olympus TJF-Q180V and Pentax ED-3490TK duodenoscopes within weeks of each other beginning in July 2017.  The Company’s goal is to receive US clearance by the end of 2017.  Clearances already exist in Europe and Canada for the terminal sterilization of both of the duodenoscopes.
    TSO3‘s STERIZONE® VP4 sterilizer is already validated and cleared in the US, Europe and Canada to terminally sterilize multi-channel flexible endoscopes, such as video colonoscopes and gastroscopes, of up to 3.5 meters in length and with four or fewer channels.
    “We are pleased to move forward and expand our duodenoscope regulatory strategy.  Filing for US duodenoscope clearance is a natural and further step in our quest to help healthcare facilities improve their standard of care by providing sterile duodenoscopes and other endoscopes to their patients,” stated R.M.(Ric) Rumble TSO3‘s President and CEO. “US regulatory clearance of duodenoscopes, along with our other healthcare-leading flexible endoscope claims, would help address industry concerns over the safety and effectiveness of less robust high-level disinfection systems.”

    Click here to read the full press release.

    Source: www.newswire.ca

    medical device investingregulatory clearancecanadaeurope
    The Conversation (0)

    Go Deeper

    AI Powered
    Stethoscope connected to a phone with medical data overlay.

    Top 5 Small-cap Medical Device Stocks (Updated January 2025)

    Intuitive Surgical Inc.

    Intuitive Surgical Inc.

    Latest News

    Outlook Reports

    Resource
    • Precious Metals
      • Gold
      • Silver
    • Battery Metals
      • Lithium
      • Cobalt
      • Graphite
    • Energy
      • Uranium
      • Oil and Gas
    • Base Metals
      • Copper
      • Nickel
      • Zinc
    • Critical Metals
      • Rare Earths
    • Industrial Metals
    • Agriculture
    Tech
      • Artificial Intelligence
      • Cybersecurity
      • Gaming
      • Cleantech
      • Emerging Tech
    Life Science
      • Biotech
      • Cannabis
      • Psychedelics
      • Pharmaceuticals

    Featured Medical Device Investing Stocks

    Cardiex Limited

    CDX:AU
    More featured stocks

    Browse Companies

    Resource
    • Precious Metals
    • Battery Metals
    • Energy
    • Base Metals
    • Critical Metals
    Tech
    Life Science
    MARKETS
    COMMODITIES
    CURRENCIES
    ×