Devices

Viz.ai Algorithm Cleared for Abdominal Aneurysms

FDA has cleared a Viz.ai 510(k) for its Viz AAA, an artificial intelligence (AI) algorithm intended to detect suspected abdominal aortic aneurysms (AAA). The device uses AI to automatically search for the presence of an abdominal aortic aneurysm from computed tomography angiography from any scanner in a hospital network, the company says. The algorithm and clinical workflow solution will be a part of the Viz AORTIC Module, an AI-supported device designed to accelerate treatment decisions for all aortic pathology, it adds.

An abdominal aortic aneurysm is a bulge in the abdominal aorta, and if left undetected and untreated, it can lead to a rupture, which is often fatal, the company says. The CDC estimates that an AAA is responsible for more than 9,000 deaths each year in the U.S.

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