Devices

Artio Medical Embolization Device Cleared

FDA has cleared an Artio Medical 510(k) for its Solus Gold Embolization Device for peripheral vascular occlusion. The company says the Solus device offers advantages over current occlusion devices and their difficulties being positioned in challenging anatomies, which often require multiple implants. “The Solus Gold device aims to overcome these limitations with a single implant designed for precision placement and immediate occlusion, even in high-flow vessels and short landing zones,” it says.

Solus is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. “Following a controlled expansion and simple mechanical detachment, the non-porous, balloon-like gold implant provides 360° vessel apposition for immediate and complete occlusion, and resists migration and recanalization,” Artio says. Pre-clinical data also showed that the device achieved immediate occlusion in over 90% of cases, including in large and high flow vessels, and demonstrated 0% migration and 0% recanalization in testing out to 3 months, according to the company.

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