Devices

Brainomix AI Stroke Tool Cleared by FDA

FDA has cleared a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence (AI) tool for stroke diagnoses. The device is a collection of tools that use AI algorithms to support doctors by providing real time interpretation of brain scans to help guide treatment and transfer decisions for stroke patients, the company says. It “assesses non-contrast CT scans to automatically generate an ASPECTS score and features a unique overlaid heatmap to visually assist clinicians to assess the output,” it says.

Brainomix describes ASPECTS as a “globally recognized” quantitative scoring system that is used to measure the extent of early ischemic changes and it is “cited as a key selection criterion for endovascular treatment in all major stroke guidelines.

“Recent studies,” it continues, “have shown that the implementation of Brainomix software enabled faster treatment by reducing door-in-door-out times by more than one hour, and improved patient outcomes by tripling the number of patients achieving functional independence after stroke, while also increasing the rates of both thrombolysis and thrombectomy by more than 50%.”

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