• 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
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    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
    The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer

    Coloplast Launches New Catheter in the U.S.

    Josh Ghaim and Sachin Jain Join Cue Health Board of Directors

    NAMSA Relaunches Medtech Outsourcing Solution

    Rollomatic Inc. Welcomes Joe Kane as CEO
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    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
    NDH Medical Inc.

    LEMO USA Inc.

    Halkey-Roberts Corporation

    Paragon Medical

    Forefront Medical Technology
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    NDH Medical Inc.

    LEMO USA Inc.

    Halkey-Roberts Corporation

    Paragon Medical

    Forefront Medical Technology
    • 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
    Top30

    26. Hoya

    ...

    26. Hoya
    Related CONTENT
    • 19. Olympus
    • 27. Hologic
    • FlexDex Names Chief Executive Officer
    • FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    • Volpara to Acquire MRS Systems
    07.30.19
    AT A GLANCE
    Rank: #26 (Last year: #26)
    $3.37 Billion ($5.1B total)
    Prior Fiscal: $3.32 Billion
    Percentage Change:+1.5%
    No. of Employees: 19,675 (37,512 total)
    Global Headquarters: Shinjuku-ku, Tokyo, Japan

    KEY EXECUTIVES
    Hiroshi Suzuki, President and CEO
    Ryo Hirooka, CFO
    Eiichiro Ikeda, COO, Information Technology and Chief Technology Officer
    Augustine Yee, Chief Legal Officer and Head of Corporate Development and Affairs

    One would think endoscope manufacturers would be extra vigilant given the bad press of recent years.

    The wave of infections topped headlines as accounts of contaminated duodenoscopes came to light. In response, in 2015 the U.S. Food and Drug Administration (FDA) mandated U.S. duodenoscope manufacturers to conduct a postmarket surveillance study assessing healthcare facilities’ ability to clean and disinfect the scopes. Specifically, the three manufacturers—Olympus, Fujifilm, and Pentax Medical (Hoya Group’s surgical division)—were ordered to conduct a study to sample and culture reprocessed scopes to glean more about the issues contributing to contamination. They were also required to perform a human factors study checking whether hospital staff were adequately trained to follow reprocessing procedures.

    None of the scope makers complied save for Fujifilm, which had only met requirements for its human factors study. Unsurprisingly, the noncompliance prompted the FDA to issue all three firms a warning letter last March. Pentax both failed to provide sufficient postmarket data and did not comply with the human factors study requirements.

    “The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a prepared statement. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

    The FDA’s not-so-gentle nudge required Pentax to submit a plan outlining how study milestones would be achieved and expected 100 percent of samples and cultures to be processed by 2018’s end. If Pentax failed to appropriately heed the FDA’s warning, retribution would likely ensue in the form of seizure, injunction, and civil money penalties.

    Pentax appears to have gotten its act together, because no such punishments have come to light. In fact, according to Hoya’s most recent financial data, the scope maker was a boost rather than a burden. Medical endoscopy sales trended strongly in Europe and the U.S. thanks to new product introductions and sales framework strengthening. Hoya’s Medical segment, which contains both Pentax and intraocular lenses (IOLs) manufactured by Hoya Surgical Optics (HSO), amassed 9.18 billion yen, rising 5 percent from the previous fiscal year. Favorable IOL trends in the Japanese market also aided this boost.

    In late December 2017, before Pentax had incurred the FDA’s wrath, it launched the C.A.P. HD Duodenoscope (ED34-i10T), the first FDA-cleared duodenoscope with a disposable distal cap. The new feature aimed to improve cleaning and reprocessing access that was hindered by a previous risk of cracks and gaps developing in the adhesive that seals the scope’s distal cap onto the scope. The new scope also features a simpler user interface, improved ergonomics and image quality, and a reduced length.

    “In my practice, the use of the ED34-i10T [C.A.P. HD Duodenoscope] has helped improve the quality of procedures as its high definition image provides increased detailed visualization of the papilla by using advanced digital imaging technologies. This allows us to differentiate between normal papillae and adenomas,” said Dr. Carlos Robles-Medranda, Guayaquil, Instituto Ecuatoriano de Enfermedades Digestivas (IECED), University Hospital OMNI, Ecuador, at the time of launch. “Additionally, the new design provides greater comfort during long procedures and requires less lever force to cannulate and maintain the required positioning, making this scope a must have tool for successful ERCP procedures.”

    Pentax also launched the J10 Series Video Naso-Pharyngo-Laryngoscopes and the DEFINA EPK-3000 Video Processor last April. The J10 Series includes a portfolio of three endoscopes, each with vivid HD image quality and advanced hygiene features. The UltraSlim HD touts a 2.4 mm distal end, currently the smallest distal end diameter on an HD video naso-pharyngo-laryngoscope available on the market. DEFINA EPK-3000 combines surface, contrast, and tone enhancement algorithms to highlight topography, edges, and color tones to augment visualization of blood vessels and surface anomalies.

    Hoya made the first of two notable investments in the endoscopy business last May. Israel-based 3NT Medical, a developer of endoscopes for ENT surgeons, closed a major portion of its $15 million financing round from Hoya. The funds will be used to complete 3NT’s family of specialty single-use endoscopes and therapeutic devices, as well as to begin U.S. and European commercialization of its Sinusway Driveable Endoscope. 3NT is Hoya’s first venture investment in an Israeli company.

    Pentax gained majority stake in PlasmaBiotics last August. The Parisian firm specializes in endoscope storage and drying, with core products that significantly reduce scope reprocessing cycle times and minimize bacterial contamination via ultra-fast endoscopic channel drying and active storage with plasma. PlasmaBiotics’ products integrate easily into most current reprocessing protocols.

    HSO began the purchase of California-based Mid Labs and Germany-based Fritz Ruck last October. Mid Labs specializes in ophthalmic surgical devices to prevent blindness caused by traumatic injuries and some retinal diseases. Fritz Ruck manufactures dual function phacoemulsification machines and accessories and distributes other ophthalmic equipment. The acquisitions fortify Hoya’s position in the IOL market and permits entry into the global retinal market, which is forecasted to grow as a result of the increasing elderly population.

    The Hoya MW10 HiKARI wearable device, which was developed based on Kyushu University contract research implemented in 2016, hit the Japanese market last November. The eyeglasses-type wearable supports dim-light vision of patients with night blindness, projecting images captured by a low-light, high sensitivity compact camera on a display screen in front of the wearer’s eyes. Unlike infrared cameras, the device amplifies faint lights in places to recreate an object’s natural color.

    Last January HSO opened the doors of its new global R&D facility aimed at developing breakthrough IOL technologies in Singapore. The move made Hoya the first IOL company in the world to establish worldwide integrated operations in Singapore—HSO’s headquarters, manufacturing plant, and R&D center are all based there.

    Hoya’s Health Care segment, comprised of eyeglass lenses, contact lenses, and related accessories, garnered 281.61 billion yen. Growth in existing business in the Americas and the recent Performance Optics acquisition provoked the 6 percent rise. New “Eyecity” retail stores and enhanced existing stores also increased new customers and grew contact lens sales.
    Related Searches
    • pentax medical
    • human factors
    • duodenoscope
    • Manufacturing
    Suggested For You
    19. Olympus 19. Olympus
    27. Hologic 27. Hologic
    FlexDex Names Chief Executive Officer FlexDex Names Chief Executive Officer
    FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    Volpara to Acquire MRS Systems Volpara to Acquire MRS Systems
    FDA Warns Against Use of Unauthorized Diabetes Management Devices FDA Warns Against Use of Unauthorized Diabetes Management Devices
    MDMA Welcomes New Board Chairman MDMA Welcomes New Board Chairman
    Sterilization Facility Shutdown Sparks Device Shortage Sterilization Facility Shutdown Sparks Device Shortage
    Developing Market Access Strategies Developing Market Access Strategies
    FDA Approves Device to Help Increase Access to More Lungs for Transplant FDA Approves Device to Help Increase Access to More Lungs for Transplant
    FDA Warns Genomics Lab About Illegally Marketing Genetic Test FDA Warns Genomics Lab About Illegally Marketing Genetic Test
    A New, Tailored Review Framework for Artificial Intelligence-Based Devices A New, Tailored Review Framework for Artificial Intelligence-Based Devices
    FDA to Modernize Mammography Services and Improve Their Quality FDA to Modernize Mammography Services and Improve Their Quality
    FDA Warns J&J and Sientra for Breast Implant Compliance Failure FDA Warns J&J and Sientra for Breast Implant Compliance Failure
    FDA to Closely Examine Surgical Stapler Risks FDA to Closely Examine Surgical Stapler Risks

    Related Top30

    • 19. Olympus

      19. Olympus

      ...
      07.30.19

    • 27. Hologic

      27. Hologic

      ...
      07.30.19

    • Surgical
      FlexDex Names Chief Executive Officer

      FlexDex Names Chief Executive Officer

      New leader has more than 25 years of experience in the medical device market.
      Globe Newswire 07.01.19


    • FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting

      FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting

      Among other changes, the agency formally ended the Alternative Summary Reporting (ASR) Program.
      U.S. Food and Drug Administration 06.24.19

    • Diagnostics | Digital Health | Software & IT
      Volpara to Acquire MRS Systems

      Volpara to Acquire MRS Systems

      The companies are committed to delivering technologies that enable personalized breast care.
      PR Newswire 06.04.19

    Loading, Please Wait..

    Trending
    • The Future Of Biomedical Engineering Advancements
    • Cirtec Medical Corporation Acquires Precision Components Business From QMD
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • A New Approach To Post-Market Surveillance
    • The Producto Group Appoints Mark C. Rauenzahn As Chief Executive Officer
    Breaking News
    • The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
    • Coloplast Launches New Catheter in the U.S.
    • Josh Ghaim and Sachin Jain Join Cue Health Board of Directors
    • NAMSA Relaunches Medtech Outsourcing Solution
    • Rollomatic Inc. Welcomes Joe Kane as CEO
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • 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

    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected
    CRN Announces Promotions and Welcomes New Staff Member
    Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study
    Coatings World

    Latest Breaking News From Coatings World

    PPG Achieves ISO 14001 Certification of Environmental Management System
    AmCoat’s Rhino Shield and Floor Shield Break Records in 2022
    Automotive Industry Leaders Form Cofinity-X JV
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
    Coloplast Launches New Catheter in the U.S.
    Josh Ghaim and Sachin Jain Join Cue Health Board of Directors
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Jones Healthcare Group Installs BOBST NOVACUT 106 ER Flatbed Die-Cutter
    Pfizer Revenues Soar to Record-Breaking $100B in 2022
    iuvo BioScience Appoints Industry Exec to Lead Lab Biz
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    La Roche-Posay Named the Fastest Growing Skincare Brand of 2022 by NielsenIQ
    Disney Collaborates with Nailtopia on Limited-Edition Nail Collection
    Knoll Wins PCD Innovation Award for MAC Advent Calendar
    Happi

    Latest Breaking News From Happi

    Color Street Launches ‘Through the Cosmos’ Collection
    Curl Care Collection is New at Native
    Color Street Pledges $100K To Support Military & Veteran Appreciation
    Ink World

    Latest Breaking News From Ink World

    International Paper Reports Full-Year, 4Q 2022 Results
    UFlex Exhibits Sustainable Printing, Packaging Solutions at Plast India 2023
    Early-Bird Registration Opens for Print UV 2023
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    SABIC announces value chain partnerships
    Digital Embellishment Alliance launches new website community
    FLAG achieves record membership in 2022
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Superior Felt & Filtration Adds Domestic Injection Molding to its Medical Filtration Capabilities
    Ahlstrom Launches New Generation FluoroFree Technology
    Berry to Begin Production at India Healthcare Hub Early This Year
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Mobi-C Cervical Disc Replacement Procedures Top 200,000
    OPUM, Corflex Global Partner on Knee Assessment Technology
    ODT's Most-Read Stories This Week—Jan. 28
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Johan Hjertonsson Proposed as New Chairman of ASSA ABLOY
    Durak Highlights SilverPro Conductive Threads
    Arkema Partners with Research Institute to Open Lab in Mulhouse, France

    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