Devices

FDA Clears Mimics Enlight Cardio Planning Software

FDA has cleared a Materialise 510(k) for its Mimics Enlight cardiovascular planning software suite. “The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures,” the company says. The device is intended to support patient selection and planning for structural heart and vascular therapy. “The TMVR workflow provides a streamlined, easy-to-use clinical workflow for planning complex procedures to correct mitral regurgitation, a disease affecting nearly one in 10 people age 75 and older,” the company says.

Materialise says the software is the first of its kind to include consistent methods of taking critical measurements. “Accurate measurements during planning are vital for predicting patients’ risk for left ventricle outflow track (LVOT) obstruction, a complication resulting in obstruction of blood flow out of the left ventricle to the rest of the body,” it says. “Using a 3D model created in Mimics Enlight Mitral improves physicians’ ability to understand and plan procedures before entering the cath lab and gives them the reliable measurements critical to successful implantation of TMVR devices in highly diseased hearts.”

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

Read more

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