Devices

Motus GI Gets New Colonoscopy Device Cleared

FDA has cleared a Motus GI Holdings 510(k) for the Pure-Vu EVS System for colonoscopies. The device is intended to improve speed of set-up, enhance navigation capabilities in tortuous anatomy, improve cleansing capabilities and enable physicians to overcome the challenges of poorly prepared colons during a colonoscopy, according to the company. “The new Pure-Vu EVS ergonomics are much better than the current version,” it says, adding that the oversleeve and the scope feel much more integrated and it is easier to torque the scope to improve navigation. “Additionally, the new EVS oversleeve is able to be loaded on a ‘dirty’ scope in the procedure room, an important new capability that will allow broader utilization of Pure-Vu to help physicians complete difficult cases and better visualize the colon mucosa,” it says.

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