Devices

Viz.ai Aneurysm Module Cleared by FDA

FDA has cleared a Viz.ai 510(k) for the Viz Aneurysm module and its use on the Viz Intelligent Care Coordination Platform for detecting suspected cerebral aneurysms from computerized tomography angiograms (CTAs). The artificial intelligence platform is currently used to coordinate care across several clinical applications, including ischemic and hemorrhagic stroke, pulmonary embolism and aortic disease in more than 1,000 hospitals, according to the company.

The new algorithm uses artificial intelligence to detect suspected cerebral aneurysms, Viz.ai says. About 3% of the population has a cerebral aneurysm and about 30,000 people suffer subarachnoid hemorrhage in the U.S. every year, which is associated with a 40% mortality rate, it says, adding that the device is intended to “serve as a first of its kind population health tool to facilitate population screening and enhanced care management.”

The clearance is based on data from a study at the University of Toronto that tested the accuracy of the Viz Aneurysm, demonstrating 94% accuracy for the algorithm, according to the company. “[Aneurysms] can be often missed because they require a very methodical diagnostic approach,” it says. “The Viz.ai aneurysm algorithm was able to detect cerebral aneurysms in consecutive CTAs.”

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