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 […]
duodenoscope
FDA clears Ambu single-use duodenoscope
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 […]
CMS moves to boost access to Boston Sci’s single-use duodenoscope
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 […]
FDA clears Olympus duodenoscope with disposable endcap
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 […]
BREAKING: FDA clears Pentax Medical duodenoscope meant to reduce superbug fears
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 […]
The grim stories behind seven of medtech’s worst failures
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 […]
