• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates

duodenoscope

5 challenges Boston Scientific overcame to make single-use scopes work

August 3, 2021 By Ray Marcano

FDA wanted single-use scopes to reduce potentially deadly superbug infections. Here’s how Boston Scientific made it happen. Boston Scientific’s Exalt Model D Single-Use Duodenoscope received FDA clearance in December 2019. It was the first device of its kind to hit the medical market. Just five months earlier, the FDA urged device manufacturers to move away from fully reusable […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Boston Scientific, duodenoscope

FDA clears Ambu single-use duodenoscope

July 17, 2020 By Chris Newmarker

Ambu announced today that FDA has cleared its aScope Duodeno — a sterile, single-use duodenoscope meant to avoid the deadly superbug outbreaks that cropped up around reusable versions of the scopes. Other companies — including Boston Scientific (NYSE:BSX),  Hoya’s (TYO:7741) Pentax subsidiary, and Olympus (TYO:7733) — have been releasing either fully disposable duodenoscopes or duodenoscopes with disporable endcaps […]

Filed Under: 510(k), Endoscopic, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Ambu, duodenoscope

CMS moves to boost access to Boston Sci’s single-use duodenoscope

June 8, 2020 By Chris Newmarker

Boston Scientific (NYSE:BSX) announced today that CMS will speed up Medicare beneficiaries’ access to single-use endoscopes, including Boston Sci’s Exalt Model D single-use duodenoscope. The Centers for Medicare & Medicaid Services (CMS) granted a Boston Sci application for a plication for a transitional pass-through (TPT) payment category — an only months-old payment category meant to provide […]

Filed Under: Diagnostics, Featured, Regulatory/Compliance Tagged With: Boston Scientific, Centers for Medicare and Medicaid Services (CMS), duodenoscope

FDA clears Olympus duodenoscope with disposable endcap

February 3, 2020 By Danielle Kirsh

Olympus (TYO:7733) announced that it won FDA clearance for its TJF-Q190V duodenoscope with a sterile, disposable distal endcap. The new duodenoscopes are designed to improve the cleaning and reprocessing of the device to reduce contamination. The device is a result of the FDA’s call for more duodenoscopes that are disposable. FDA in August 2019 recommended that […]

Filed Under: Endoscopic, Featured, Food & Drug Administration (FDA), Imaging Tagged With: duodenoscope, Olympus

BREAKING: FDA clears Pentax Medical duodenoscope meant to reduce superbug fears

November 15, 2019 By Chris Newmarker

The FDA today announced that it has cleared a duodenoscope from Hoya’s (TYO:7741) Pentax subsidiary that has a sterile, disposable elevator — a first in the U.S. The Pentax Medical duodenoscope’s design reduces the number of parts requiring cleaning and disinfection between uses, according to the FDA. Reducing reprocessing challenges, the thinking goes, will help prevent […]

Filed Under: 510(k), Endoscopic, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: duodenoscope, Pentax, superbugs

The grim stories behind seven of medtech’s worst failures

April 19, 2019 By Danielle Kirsh

Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention. For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Diagnostics, Food & Drug Administration (FDA), Implants, Metal-on-Metal, Regulatory/Compliance Tagged With: Bayer, birth control, duodenoscope, Essure, MedTech, Medtronic, metal-on-metal hips, pacemakers, Theranos

Primary Sidebar

DeviceTalks Weekly

July 1, 2022
Boston Scientific CEO Mike Mahoney on building a corporate culture that drives high growth results
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS