Devices

FDA Clears Revamped Pentax Duodenoscope

FDA has cleared a Pentax of America 510(k) for the first duodenoscope with a disposable distal cap, a new feature that is intended to improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is indicated for use in visualizing and accessing to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. “We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” CDRH Office of Device Evaluation acting director William Maisel is quoted in a release as saying. “Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients.”

The new clearance is intended to address concerns raised earlier this year in a safety communication about a design issue with an earlier version of the Pentax duodenoscope, the ED-3490TK. The alert identified the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope's distal cap onto the scope, which could allow fluids and tissue to leak into 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