Devices

FDA Approves Olympus Device for Emphysema

FDA has approved Olympus’ Spiration Valve System (SVS) for treating severe emphysema, a progressive form of chronic obstructive pulmonary disease (COPD). Approval was based on data from the EMPROVE clinical trial demonstrating that patients treated with the SVS “benefited from statistically significant and clinically meaningful improvements in lung function and quality of life compared to standard of care medical management,” the company says. Additionally, it says that data showed the device offers a favorable risk benefit profile related to its short procedure time, which may reduce adverse event risks. Serious adverse events observed in the study include COPD exacerbations, air leak (pneumothorax), pneumonia and death.

The SVS is placed in targeted airways of the lung during a short bronchoscopic procedure. Its umbrella shape is designed to improve breathing by blocking airflow to the diseased portion of the lung, Olympus says. “SVS therapy leads to volume reduction in the treated part of the lung, allowing the healthier tissue in the remaining portion of the lung to function better,” it adds.

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