Devices

MR Contour DL Model Cleared for Organ Segmentation

FDA has cleared a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence (AI) model that uses deep learning for organs-at-risk (OAR) segmentation. The device “leverages the soft-tissue detail of MR [magnetic resonance] images to create precise organ contours of OAR during radiation therapy treatment planning, a process that was previously entirely manual, bringing efficiency, consistency, and accuracy,” the company says. The AI model is capable of segmenting 37 organs and structures in the head, neck and pelvic regions based on standard 2D or 3D MR image datasets, it adds.

GE says the device will be integrated into its updated Intelligent Radiation Therapy solution for radiation therapy workflow management, which enables a complete AI-powered, MR-only simulation workflow to help deliver more precise radiation therapy treatment.

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