Drugs

Brainomix Gets Clearance for AI e-Lung Tool

FDA has cleared a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging. The artificial intelligence-based workflow enhancement and visualization tool helps assess CT scans and thoracic datasets, providing automatic and objective quantifications of the lungs including lung segmentation, volumetric measurements, structural and coarse density evaluations, the company says.

The clearance is based on recent data from Brainomix that demonstrated e-Lung biomarkers’ capability to predict both short- and long-term outcomes in idiopathic pulmonary fibrosis (IPF) and non-IPF cohorts, including relative Forced Vital Capacity (FVC) decline and survival, the company says. “When compared to current standard measures, including FVC and radiological assessment, e-Lung biomarkers were a better predictor of survival when assessing change between two timepoints,” it says. “Brainomix's proprietary e-Lung biomarkers have been trained using thousands of CT scans from leading academic institutions to accurately quantify pulmonary fibrosis and other characteristics.”

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