Devices

Olympus ‘Enhanced Reprocessing’ Duodenoscope Cleared

FDA has cleared an Olympus 510(k) for the TJF-Q190V duodenoscope with a sterile, disposable distal endcap. The device is designed to improve its cleaning and reprocessing to reduce potential contamination, the company says, adding that it responds to the agency’s call for duodenoscopes with disposable components that improve access to the elevator mechanism to simplify reprocessing. Olympus says it features:

A sterile, clear, single-use distal endcap cover that is removed and discarded post-procedure. The design prevents the possibility of reuse.
Improved visualization of and access to the distal end for manual cleaning and disinfection.
A proprietary distal-end flushing adaptor for cleaning the elevator mechanism.
A sealed elevator wire channel port that does not require separate cleaning.
A new water-resistant scope connector that minimizes the risk of fluid ingress.

Olympus says it will also “perform periodic inspection and maintenance of every TJF-Q190V based on frequency of reprocessing, to better ensure that normal wear and tear does not compromise the functionality of the duodenoscope or the ability to properly reprocess the duodenoscope.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome