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HOYA Surgical Optics, Inc.

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Latest From HOYA Surgical Optics, Inc.

Pentax Medical Pushes People, Product And Process Amid New US FDA Guidance

With the US FDA urging providers to transition away from fixed duodenoscopes to newer designs that reduce or eliminate reprocessing of the device, Pentax Medical is seizing an opportunity to increase supply of its disposable cap scope. Medtech Insight talks to the company’s global clinical officer, Garrett Hudson, on the challenges of endoscopy hygiene and the company’s response to guidance.

FDA Gastroenterology

Continued Risks Of Duodenoscopes Leads FDA To Recommend Disposable Cap Devices

After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.

Regulation Safety

US FDA Says Custom Ultrasonics Device May Be Used To Disinfect Certain Duodenoscopes

Custom Ultrasonics' System 83 Plus automated endoscope reprocessors may now be used to disinfect specific models of Olympus and Pentax duodenoscopes, FDA says.

Regulation Recalls

FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order

US FDA sent the letters to

FDA Enforcement
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Company Information

  • Industry
  • Medical Devices
    • Diagnostic Imaging Equipment & Supplies
    • Surgical Equipment & Devices
      • Minimally or Less Invasive
  • Other Names / Subsidiaries
    • Daemyung Optical
    • C2 Therapeutics
    • Microline Surgical Inc.
    • Pentax Medical
    • Performance Optics, LLC
    • VISION EASE
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